ORIGINAL ARTICLE
Effect of prophylactic percutaneous endoscopic gastrostomy tube on swallowing in
advanced head and neck cancer: A randomized controlled study
Lars Axelsson, MD,1* Ewa Silander, RD, PhD,1 Jan Nyman, MD, PhD,2 Mogens Bove, MD, PhD,3 Leif Johansson, MD, PhD,4 Eva Hammerlid, MD, PhD1
1
Department of Otorhinolaryngology – Head and Neck Surgery, University of Gothenburg, Sahlgrenska University Hospital, G€oteborg, Sweden, 2Department of Oncology,
Sahlgrenska University Hospital, G€oteborg, Sweden, 3Department of Otorhinolaryngology, NU Hospital Group, Trollh€attan, Sweden, 4Department of Otorhinolaryngology,
Central Hospital, Sk€ovde, Sweden.
Accepted 9 December 2016
Published online 2 February 2017 in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/hed.24707
ABSTRACT: Background. Dysphagia is common in head and neck can-
cer. A percutaneous endoscopic gastrostomy (PEG) tube is used to facili-
tate nutrition; however, some retrospective studies have indicated that
the PEG tube causes dysphagia.
Methods. A randomized study of patients with head and neck cancer
was conducted with up to 10 years of follow-up. Patients were random-
ized to either the prophylactic PEG tube group (study group) or the com-
mon clinical nutritional support group (control group). At each follow-up,
a dietician assessed the oral intake, noted the patients’ weight, and if
the patients used a PEG tube. Dysphagia was also assessed by the qual-
ity of life questionnaire, European Organization for Research and Treat-
ment of Cancer Quality of Life Questionnaire-Core 30 Head and Neck
35-questions (EORTC-QLQ-H&N35).
INTRODUCTION
It is well known that head and neck cancer can cause dys-
phagia because of pain or obstruction from the cancer, or
from side effects of the treatment. In a study of patients
with advanced head and neck cancer treated with chemo-
radiation, the prevalence of dysphagia was 54%.1 Dyspha-
gia often leads to malnutrition with an increased risk
of treatment interruption, extended rehabilitation, and
decreased survival.2 Apart from providing nutritional
advice and supplements, it is unclear if there is a best
method for ensuring adequate nutrition in advanced cases
of head and neck cancer. Some studies have reported
good results giving enteral nutrition with a reactive naso-
gastric tube (rNGT; used when the patients have a clinical
need),3,4 whereas others preferred a prophylactic percuta-
neous endoscopic gastrostomy (pPEG) tube or reactive
percutaneous endoscopic gastrostomy (rPEG) tube.5,6
*Corresponding author: L. Axelsson, Department of Ear, Nose, and Throat, and
Head and Neck Surgery, University of Gothenburg Sahlgrenska University
Hospital, G€oteborg, Sweden. E-mail address: lars.axelsson@vgregion.se
Contract grant sponsor: This study was supported by the G€oteborg Medical
Society, the Stiftelsen Acta Oto-Laryngologica, the Stiftelsen Assar Gabriels-
sons Foundation, the Research and Development Council V€astra G€otaland
County (Sweden), the ALF project funding for clinically oriented medical
research projects V€astra G€otaland County (Sweden).
908 HEAD & NECK—DOI 10.1002/HED MAY 2017
Results. One hundred thirty-four patients were included in this study.
There was no significant difference in swallowing function between the
groups after 12 months, 24 months, and 8 years based on the EORTC-
QLQ-H&N35, the oral intake scale, tube dependence, esophageal inter-
vention, weight, body mass index (BMI), and overall survival.
Conclusion. A prophylactic PEG tube can be used without an increased
risk of long-term dysphagia in patients with head and neck cancer. V C
2017 Wiley Periodicals, Inc. Head Neck 39: 908–915, 2017
KEY WORDS: percutaneous endoscopic gastrostomy, dysphagia,
swallowing function, head and neck cancer, randomized controlled
study
Because a nasogastric tube (NGT) can be uncomfortable
for some patients, especially if there is a long-term need
for enteral nutrition, both pPEG and rPEG tubes are fre-
quently used. The prophylactic endoscopic gastrostomy
(PEG) tube is associated with risk of complications in the
short-term, such as local infection, the formation of gran-
ulation tissue around the stoma, and a low risk of peritoni-
tis. There is, however, a great deal of variability in the
reported incidence of these complications.7,8 More recently,
several studies have reported that long-term dysphagia may
be associated with the use of a PEG tube.4,9–11 The authors
hypothesized that, when compared with NGT, a PEG tube
may cause a more pronounced atrophy of the muscles
responsible for swallowing because of a prolonged absence
of oral intake.12 This hypothesis could be discussed
because, although the patients with a PEG tube do not swal-
low enough food or liquids, they still swallow their saliva
and liquids if they are able to. Most of these studies have
been retrospective, and, therefore, subject to the flaws
inherent in this type of study design and differences
between the study and control groups include, for example,
primary tumors, tumor stage, and the radiation volume and
dose.4 Nevertheless, the conclusions from these studies
have led to a restriction in the use of PEG tubes in several
countries with the unfortunate consequence of potentially
increasing the risk of malnutrition in these patients.
 EFFECT
We have previously published a randomized controlled
study in patients with advanced head and neck cancer
investigating whether a pPEG tube for enteral nutrition
(study group) could prevent malnutrition and improve
health-related quality of life. The control group received
nutritional support according to clinical praxis, including
rNGT or rPEG tubes if needed. The original study
showed no difference in hospitalizations between the 2
groups, but the PEG tube group had better quality of life,
less weight loss, and a lower number of patients consid-
ered to be malnourished 6 months after inclusion, but
these differences did not persist at the 1-year and 2-year
follow-up.13 In the current study, we conducted a long-
term follow-up of the same groups of patients. The pur-
pose of the present study was to determine if there were
any differences in the severity and frequency of dyspha-
gia between the 2 randomized groups 8 years after
treatment.
PATIENTS AND METHODS
Inclusion and randomization
Surviving patients previously participating in our pub-
lished study by Silander et al,13 “Impact of prophylactic
percutaneous endoscopic gastrostomy on malnutrition and
quality of life in patients with head and neck cancer: a
randomized study,” were contacted again after receiving
approval from the Regional Ethics Committee in Gothen-
burg, Sweden, in 2012.
The patients were initially diagnosed between 2002 and
2006 with advanced (stages III–IV) oral, hypopharyngeal,
oropharyngeal, or nasopharyngeal cancer, or malignant
neck nodes from an unknown primary cancer and were
treated with curative intent.
The patients were randomized at the Regional Cancer
Registry of Gothenburg, Sweden, to a pPEG (study
group) or nutritional support according to clinical practice
(control group). A computer-based randomization algo-
rithm was used to ensure an even distribution of patients
between the 2 treatment groups. Patients randomized to
the study group had PEG surgery at their local hospital
before the start of treatment.
PATIENTS AND METHODS
The European Organization for Research and Treatment
of Cancer Quality of Life Core 30 questionnaire
(EORTC-QLQ-C30) consists of 30 items relevant to all
patients with cancer.14 In this study, only the results from
2 items (questions 29 and 30) that measured overall quali-
ty of life were used. The EORTC-QLQ-H&N35 consists
of 35 items for patients with head and neck cancer.15
From this questionnaire, 3 scales: (1) the swallowing
scale; (2) the social eating scale; and (3) the pain scale,
and 2 single items: (1) problems with dry mouth; and (2)
opening mouth wide were analyzed. Furthermore, the fol-
lowing 2 items in the swallowing scale were analyzed
separately: problems swallowing liquids and problems
swallowing solid food. For these 2 items, the response
categories “not at all” and “a little” were combined into 1
group representing minimal problems, whereas the 2
response categories “quite a bit” and “very much” were
combined into another group representing significant
OF PROPHYLACTIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY ON SWALLOWING
problems. For the scales, the values ranged from 0 to
100. For the scales in the Head and Neck Module 35, a
higher value represented increasing problems. For global
quality of life, a higher value represented good quality
of life.
The dysphagia was assessed using a nonvalidated 5-
level ordinal oral intake scale with scores ranging from 1
to 5 as follows: 1 5 normal diet; 2 5 semisolid diet; 3 5
pureed diet; 4 5 liquid diet; and 5 5 unable to eat.
Body mass index (BMI) was calculated from the for-
mula weight (kg)/height2 (m2) and was used to assess if a
patient was underweight, normal, overweight, or obese.
Normal weight corresponded to a BMI of 18.5 to 24.9.
Follow-up
At each follow-up visit, a dietician assessed the
patient’s oral intake, obtained the weight, and calculated
the BMI. In addition, it was noted if the patients were
using a tube (PEG or NGT). During the visit, the patients
also completed the quality of life questionnaires, EORTC-
QLQ-C30 and EORTC-QLQ-H&N35.
The patients were assessed at 8 different time points: at
inclusion, after 1 month, 2 months, 3 months, 6 months,
12 months, and 24 months, and at a long-term follow-up
visit after 6 to 10 years (mean, 8 years). At the long-term
follow-up, the patients were examined both by a physi-
cian and by a dietician.
In this long-term study, the results obtained at inclu-
sion, after 12 months, after 24 months, and after 8 years
(in mean) are presented.
Tumor treatment
Patients were treated according to the decision made at
the hospitals’ multidisciplinary tumor conference. Usual-
ly, patients with advanced (stages III and IV) oral or
unknown primary cancer were treated with surgery con-
sisting of an excision of the primary tumor, neck dissec-
tion, and postoperative radiation. Patients with pharyngeal
cancer were treated with chemoradiation.
During the study period, radiation was administered
according to a standard fractionated schedule of 64.6 Gy
in 5 weeks. The chemotherapy usually consisted of induc-
tion therapy with 2 cycles of cisplatin and 5-fluorouracil.
Statistical analysis
Statistical analyses were conducted using SAS software.
The results are presented as the means, range, median,
and percent. To compare the results between groups, the
Mann–Whitney U test was used for continuous variables,
the Fisher’s exact test for dichotomous variables, the
Mantel–Haenszel chi-square test for ordered categorical
variables, and the chi-square test for nonordered categori-
cal variables. The Kaplan–Meier curves were calculated
for survival, and the difference between the groups was
tested using the log-rank test. All significance levels were
2-tailed and conducted at the 5% significance level. For
the EORTC-QLQ-C30 and EORTC-QLQ-HN35 scales, a
difference of 10 units or more between groups was con-
sidered a significant clinical difference.16,17
HEAD & NECK—DOI 10.1002/HED MAY 2017 909
AXELSSON ET AL.
RESULTS
A total of 359 patients were diagnosed with oral, pharyn-
geal, or unknown primary cervical cancer in Western Sweden
during the inclusion period, and 234 patients fulfilled the
inclusion criteria. Two hundred two patients were asked to
participate, and 145 patients agreed to take part in the study
(57 declined; 28%). Of the 145 patients randomized to the
study or control groups, 11 patients were excluded after the
randomization for various reasons (8 in the study group and 3
in the control group). Finally, 134 patients were included, 64
in the study group and 70 in the control group (Figure 1).
There was no significant difference in age, sex, tumor
site, T classification, N classification, tumor stage, treat-
ment, weight, BMI, and performance status between the
study and control groups (Table 1). The mean age of the
910 HEAD & NECK—DOI 10.1002/HED MAY 2017
FIGURE 1. Consolidated Stand-
ards of Reporting Trials flow
diagram showing the inclusion
process.
patients was 62 years, and two thirds of the participants
were men. The mean BMI at inclusion was 24.8. The
majority of the patients were diagnosed with oropharyngeal
cancer (58%) and oral cancer (31%). Most patients had T4
disease (39%), and 75% were N-positive classification.
The most common treatment was chemoradiation (70%).
Six patients in the study group and 6 patients in the control
group had a recurrence within 24 months from inclusion.
At the long-term follow-up after 8 years, none of the 32
patients in the study group and 2 of the 30 patients in the
control group had been treated for a recurrence.
Quality of life questionnaires
The global quality of life scale from the EORTC-QLQ-
C30 and the selected scales and items related to the
 EFFECT OF PROPHYLACTIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY ON SWALLOWING

TABLE 1. Patient, disease, and treatment characteristics. reported “quite a bit” or “very much” with regard to
problems swallowing solid food; the problems were at the
Randomization group Study group Control group same levels after 24 months and after 8 years, and the
No. of subjects 64 70 results were comparable between the 2 groups. Rather
Age, y, mean (range) 63 (41–87) 60 (35–83) few patients had “quite a bit” or “very much” problems
Sex, no. (%) with swallowing liquids during the study period.
Male 43 (67) 48 (69)
Female 21 (33) 22 (31) Oral intake scale
Tumor site
The patients’ swallowing function was also assessed by
Oropharynx 37 (58) 41 (58)
Oral cavity 22 (34) 20 (29) a dietitian with a 5-level scale: 1 5 normal diet; 2 5
Unknown primary 3 (5) 7 (10) semisolid diet; 3 5 pureed diet; 4 5 liquid diet; and 5 5
Hypopharynx 2 (3) 0 unable to eat (Table 2). At inclusion, there were a few
Nasopharynx 0 2 (3) patients with levels 4 and 5 swallowing function in the
T classification control group and none in the study group. However,
T1 9 (14) 8 (11) there were more patients with level 3 swallowing function
T2 17 (27) 16 (23) in the study than in the control group. After 24 months
T3 10 (16) 11 (16) and 8 years, there was no significant difference in the
T4 24 (38) 28 (40)
oral intake scale values between the groups. At inclusion,
T0 3 (5) 7 (10)
N-positive 47 (73) 54 (77) 69% of all patients could eat a normal diet, and after
Tumor stage 8 years, the number increased to 85%. After 8 years, only
III 16 (25) 18 (26) a few patients in both groups were restricted to semisolid
IV 48 (75) 52 (74) food, and only 1 patient could only swallow liquids.
Treatment According to the oral intake scale, patients had most
S 1 CRT 2 (3) 2 (3) swallowing problems after 3 months and the least swal-
S 1 RT 10 (16) 9 (23) lowing difficulties after 8 years.
CRT 44 (69) 49 (70)
RT 7 (11) 3 (4) Remaining feeding tube and esophageal intervention
Interrupted* 1 (2) 7 (10)
Weight, kg, mean (median) 75 (75) 75 (77) All patients in the study group had a pPEG and 6
BMI, mean (median) 24.9 (24.8) 24.8 (24.9) patients in the control group received an rPEG for enteral
KPS, no. (%) nutrition within the first 16 months after the treatment
100 33 (52) 32 (46) started.
90 23 (36) 24 (34) In Table 2, the number of patients using a feeding tube,
80 5 (8) 12 (17)
either PEG or NGT, was evaluated for both groups. After
70 3 (5) 2 (3)
12 months, 4 patients used a feeding tube in each group,
after 24 months, 1 patient in each group used a feeding
Abbreviations: S 1 CRT, surgery and chemoradiation; S 1 RT, surgery and radiotherapy;
CRT, chemoradiation; RT, radiotherapy; BMI, body mass index; KPS, Karnofsky Performance tube, and, after 8 years, no patient used a tube in any
Scale. group. The mean (median) use of a tube for enteral feed-
* Interrupted treatment was defined as that the patient who received less than the full dose of
radiation (64.6 Gy). These patients died during or shortly after the treatment.
ing was 177 days (149 days) for the study group and 122
days (79 days) for the control group, as reported previ-
ously by Silander et al.13
The medical records of all patients were reviewed at
swallowing function from the EORTC-QLQ-H&N35 are
the long-term follow-up visit for the results of X-rays, the
presented in Table 2. The results presented in this long-
need for procedures, such as endoscopy and dilatation of
term study are those obtained at inclusion, after 12
the esophagus, and the presence of symptoms of hypo-
months, after 24 months, and 8 years. There was no sig-
pharyngeal and esophageal disease. Three patients (5%)
nificant difference between the study and control groups
at any time point with regard to the global quality of life, in the study group and 6 patients (9%) in the control
swallowing, social eating, pain, dry mouth, and opening group underwent X-rays of the esophagus. Three patients
of the mouth. The results from the swallowing and social in each group (5% in the study and 4% in the control
eating scales are shown in more detail in Figures 2 and 3. group) underwent endoscopy of the esophagus. No patient
The swallowing function was worst after 1 to 3 months in the study group and 1 patient (1%) in the control group
but returned to the same level noted at inclusion after 24 underwent dilatation for an esophageal stricture.
months and 8 years. The problems with dry mouth and
opening the mouth wide increased after treatment and
Weight and body mass index
remained a problem without improvement at the long- The patients’ weight was obtained, and BMI was calcu-
term follow-up. Two of the items from the swallowing lated during the study period (Table 2). The mean and
scale, problems swallowing liquids and problems swal- median weights at inclusion for the study group was 75
lowing solid foods, were analyzed separately to further kg (median, 75 kg) and 75 kg (median, 77 kg) for the
examine the swallowing function. The results from the 4 control group with no difference in weight after 8 years,
response categories were divided into 2 groups: “not at 76 kg (median, 77 kg) and 75 kg (median, 74 kg), respec-
all” and “a little” versus “quite a bit” and “very much” tively. There was no significant difference in BMI
(Table 2). At inclusion, about one fourth of the patients between the study and control groups, although the BMI

HEAD & NECK—DOI 10.1002/HED MAY 2017 911

AXELSSON ET AL.

TABLE 2. Results from selected scales and items in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core
30-questions and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Head and Neck 35-questions,
the oral intake scale, remaining feeding tube, and the body mass index for the study and control groups at different time points.

Inclusion 12 mo 24 mo 8y
Randomization group Study Control p value Study Control p value Study Control p value Study Control p value

No. of subjects 64 70 54 54 48 46 32 30
EORTC-QLQ-C30 scales
(score) mean
Global health status 67 63 .27 68 66 .43 77 70 .27 71 79 .083
EORTC-QLQ-H&N35
scales (score) mean
Swallowing 12 19 .20 22 25 .51 19 21 .88 21 18 .97
Social eating 15 20 .32 25 26 .80 20 20 .96 17 14 .36
Pain 25 28 .74 29 27 .51 21 22 .66 16 18 .41
Dry mouth 19 21 .59 72 72 .95 66 67 .89 58 63 .59
Opening mouth 15 19 .28 33 33 1.0 23 33 .19 34 38 .72
Items, no. (%)
Swallow liquids*
1–2 59 (95) 63 (91) 52 (96) 48 (89) 45 (96) 39 (91) 29 (91) 28 (100)
3–4 3 (5) 6 (9) .60 6 (11) .27 2 (4) 4 (9) .61 3 (9) 0 .28
Swallow solid food*
1–2 47 (76) 47 (69) 35 (65) 36 (67) 32 (68) 34 (79) 23 (72) 22 (79)
3–4 15 (24) 21 (31) .51 19 (35) 18 (33) 1.0 15 (32) 9 (21) .32 9 (28) 6 (21) .93
Oral intake scale no. (%)†
1 46 (72) 46 (66) 36 (67) 29 (54) 33 (69) 32 (70) 27 (84) 26 (87)
2 12 (19) 13 (19) 14 (26) 14 (26) 12 (25) 8 (17) 4 (13) 2 (7)
3 6 (9) 4 (6) 1 (2) 3 (6) 1 (2) 0 1 (3) 1 (3)
4 0 6 (9) 2 (4) 3 (6) 0 6 (13) 0 1 (3)
5 0 1 (1) .14 1 (2) 5 (9) .057 2 (4) 0 .60 0 0 .84
Mean scale value 1.4 1.6 1.5 1.9 1.5 1.6 1.2 1.2
Remaining tubes, no. (%) 0 0 1.0 4 (7) 4 (7) 1.0 1 (2) 1 (2) 1.0 0 0 1.0
BMI mean 24.9 24.8 .91 22.5 21.8 .40 23.4 23.0 .63 25.1 24.8 .84

Abbreviations: EORTC-QLQ-C30, European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Cancer 30 questions; EORTC-QLQ-H&N35, European Organization for
Research and Treatment of Cancer-Quality of Life Questionnaire-Head and Neck 35 questions; BMI, body mass index.
A high score on global quality of life scale represents a high function, while a high score on the other scales represents a high level of problems.
* Have you had problems swallowing liquids / swallowing solid food: 1 5 not at all; 2 5 a little; 3 5 quite a bit; and 4 5 very much.
†
The oral intake scale: 1 5 normal diet; 2 5 semisolid diet; 3 5 pureed diet; 4 5 liquid diet; and 5 5 unable to eat.

tended to be a little higher in the study group than in the Survival

control group after 12 months, 24 months, and 8 years. The survival rate is shown in Figure 4. The overall 2-
After 8 years, the BMI reverted to the value at inclusion. year, 5-year, and 10-year survival rates for all patients

FIGURE 2. Results from the

swallowing scale in the Europe-
an Organization for Research
and Treatment of Cancer Quality
of Life Questionnaire Head and
Neck 35-questions (EORTC-
QLQ-H&N35) for the study and
control group at different time
points. The results are shown
as mean values. The higher the
value, the more problems there
were.

912 HEAD & NECK—DOI 10.1002/HED MAY 2017

 EFFECT OF PROPHYLACTIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY ON SWALLOWING

FIGURE 3. Results from the

social eating scale in the Euro-
pean Organization for Research
and Treatment of Cancer Quality
of Life Questionnaire Head and
Neck 35-questions (EORTC-
QLQ-H&N35) for the study and
control group at different time
points. The results are shown
as mean values. The higher the
value, the more problems there
were.

from both groups was 73%, 61%, and 47%, respectively.
The 2-year, 5-year, and 10-year survival rates for the
study group was 77%, 64%, and 48%, respectively, and
for the control group was 70%, 59%, and 46%, respec-
tively. No significant difference in survival was found.
DISCUSSION
Dysphagia and malnutrition are common complications
in advanced head and neck cancer, and a PEG tube can
be used to ensure adequate enteral nutrition. Some retro-
spective and 1 prospective nonrandomized study have
indicated that a PEG tube can cause dysphagia in the
short-term18–20 and long-term,4,9,10,21 but, to our
knowledge, no randomized controlled study has been per-
formed to confirm this assertion. In the current random-
ized controlled long-term follow-up study of 134 patients
with advanced head and neck cancer, we investigated
whether pPEG caused dysphagia using a variety of
approaches.
One method with which to assess swallowing function
is to use patient-reported questionnaires. The results from
selected symptom scales related to swallowing from the
quality of life questionnaires, EORTC-QLQ-C30 and
EORTC-QLQ-H&N35, showed no significant difference
between patients having a pPEG and those who did not
after 12 months, after 24 months, and after 8 years. Vari-
ous swallowing questionnaires have been used previously

FIGURE 4. Kaplan–Meier curve

of the overall survival from
inclusion for the study and con-
trol groups. The number of
patients at risk is shown at the
bottom of the figure.

HEAD & NECK—DOI 10.1002/HED MAY 2017 913

AXELSSON ET AL.
to assess dysphagia in patients with pPEGs, as summa-
rized by Shaw et al.22 The results from these studies dif-
fer. For example, Oozeer et al9 retrospectively included
31 patients with cancer of the head and neck in 2
matched groups receiving a pPEG or an rNGT and used a
dysphagia questionnaire to evaluate swallowing outcomes
(MD Anderson Dysphagia Inventory). In contrast to our
study, the authors reported significantly better swallowing
outcomes in the rNGT group than in the pPEG group.
The Oozeer et al9 study, however, included a small sam-
ple of patients and lacked information regarding pretreat-
ment swallowing function. Conversely, a retrospective
study by Prestwich et al23 reported an outcome in line
with our results, finding no difference in the long-term
swallowing function of 2-year survival patients with oro-
pharyngeal cancer who received either a pPEG or an
rNGT. The results from the quality of life questionnaires
in the current study suggest that use of a pPEG in patients
with head and neck cancer does not increase the risk of
long-term dysphagia.
The patients’ swallowing function was also assessed
with a 5-level oral intake scale. At inclusion, a small
number of patients in the control group, but none in the
study group, could only swallow liquids or were unable
to eat. After 24 months and at the long-term follow-up,
there was no difference between the groups in the
patients’ ability to swallow foods of different textures.
Different swallowing scales have been used in previous
studies.22 For example, Williams et al10 and Prestwich
et al23 used a swallowing assessment tool similar to the
one used is this study. Although it has not been validated,
the 5-level oral intake scale provides significant informa-
tion about the swallowing function.
Another indicator of dysphagia is the duration of a
patient’s need for a feeding tube, a PEG or NGT. In the
present study, 8 of the 108 surviving patients used a feed-
ing tube after 12 months, 2 of 94 patients after 24
months, and none after 8 years. At all of these time
points, the use of a feeding tube was equal in both
groups. The mean and median use of a tube for enteral
feeding was longer for the study group (177 days [medi-
an, 149 days]) than for the control group (122 days
[median, 79 days]), even though the patients in both
groups were encouraged to drink/eat as much as possible
during their tube-dependence. Several authors have used
the duration of tube dependence in patients with head and
neck cancer after pPEG versus non-pPEG use as an indi-
cator of dysphagia.5,10,18,21 Chen et al,18 Williams et al,10
and Pohar et al21 reported an increased risk of tube
dependence after pPEG, whereas Rutter et al5 found no
difference between the groups. Again, because all of these
studies were retrospective, it is difficult to draw any firm
conclusions. The current study found that although the
pPEG tube is associated with a longer use of a feeding
tube during the first year, there is no increased risk of
long-term tube dependence.
To examine if the patients developed clinically relevant
esophageal strictures, medical records were reviewed at
the long-term follow-up visit for the results of X-rays and
the need for procedures, such as endoscopy and dilatation
of the esophagus. No significant difference was found
between the pPEG and non-pPEG groups in any of these
914 HEAD & NECK—DOI 10.1002/HED MAY 2017
parameters. Only 4% of all patients were examined with
endoscopy, and 1 patient (<1%) underwent dilatation for
an esophageal stricture. In a retrospective case-control
study of 136 patients with head and neck cancer, Ahlberg
et al24 found a strong association between enteral feeding
during radiotherapy and the development of esophageal
strictures. However, several limitations with this study
include the retrospective design and differences in tumor
stages, as well as differences and uncertainties regarding
the doses of radiation to the upper esophagus (more than
50% missing data) between the groups. Enteral feeding
during radiotherapy can be considered a prognostic factor
for the risk of developing a stricture rather than the cause
of a stricture. Another retrospective study by Chen et al18
studied 120 consecutive patients treated with chemoradia-
tion for advanced head and neck cancer and compared
outcomes of pPEG tube and non-pPEG tube use. The
authors reported that more patients were examined with
endoscopy of the esophagus because of persistent dyspha-
gia in the pPEG tube group than the non-pPEG tube
group (44% in the pPEG tube group and 18% in the non-
pPEG tube group). Overall, a much higher percentage of
patients in the Chen et al18 study underwent endoscopic
examination than in our study. The higher need of esoph-
ageal endoscopy in the Chen et al18 study could partly be
explained by a higher proportion of hypopharyngeal and
laryngeal cancer and by differences in the radiation proto-
cols. The differences between the 2 groups could, as dis-
cussed by the authors, probably be explained by
differences in the radiation dose of the mucosa, in tumor
size/involvement of the larynx/hypopharynx, and in pre-
treatment nutritional status. According to our results, the
use of a pPEG tube does not seem to increase the risk for
esophageal strictures.
The patients’ weight and BMI were recorded as an
indicator of their nutritional status, and no significant dif-
ference was found between the groups after 12 months,
after 24 months, and after 8 years. After 8 years, the BMI
had returned to the same level noted at inclusion. Thus,
the pPEG tube and common nutritional support in patients
with head and neck cancer seem to have the same long-
term nutritional outcome.
The overall 5-year survival rate for all the patients in
the study with advanced head and neck cancer was rela-
tively high at 61%. There was no significant difference in
overall survival between the pPEG tube group and the
common nutritional support group during the long follow-
up. Previous studies comparing patients with the pPEG
tube and the non-pPEG tube have not shown any signifi-
cant difference in survival between the groups.10,18
The current study was prospective and randomized.
However, a limitation of the study was that relatively few
patients were available 6 to 10 years after diagnosis. The
5-year survival rate for advanced head and neck cancer in
general is below 50%. In this study, the survival rate was
relatively high (5-year survival 61%) and compliance was
good, 60 of 62 patients answered the EORTC-QLQ ques-
tionnaires at the long-term follow-up. Nonetheless, it
would have been favorable to include more patients. A
problem with intervention studies could be that more
patients in the study group tend to leave the study than in
the control group after randomization because of their
 EFFECT
hesitation regarding the interventional treatment. In the
present study, 8 patients in the study group and 3 patients
in the control group withdrew their informed consent.
The number was small, however, compared with previous
studies. In a prospective study by Corry et al,19 the
patients refused to allow the randomization process to
determine the type of feeding tube they would be
assigned and, as a result, the randomization protocol
needed to be discarded. Another limitation was that no
validated dysphagia scale was used. Instead, a nonvali-
dated 5-level oral intake scale was used, chosen when the
study started in 2002. At that time, there were few vali-
dated scales assessing the patient’s ability to swallow
foods of different textures.
CONCLUSIONS
In this randomized controlled follow-up study of
patients with advanced head and neck cancer, the use of
pPEG tubes compared with common nutritional support
up to 10 years from the time of inclusion resulted in no
difference in swallowing function, as assessed by quality
of life questionnaires and a 5-level oral intake scale, tube
dependence, and the prevalence of clinically relevant
esophageal strictures. There was no difference in weight,
BMI, and overall survival between the groups. We con-
clude that pPEG tubes can be used without an increased
risk of long-term dysphagia in patients with advanced
head and neck cancer.
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HEAD & NECK—DOI 10.1002/HED MAY 2017 915