Background
Approximately 9000 new cases of head and neck squamous cell cancers
(HNSCCs) are treated by the NHS each year. Chemoradiation therapy (CRT) is a
commonly used treatment for advanced HNSCC. Approximately 90% of patients
undergoing CRT require nutritional support via gastrostomy or nasogastric tube
feeding. Long-term dysphagia following CRT is a primary concern for patients.
The effect of enteral feeding routes on swallowing function is not well
understood, and the two feeding methods have, to date (at the time of writing),
not been compared. The aim of this pilot randomised controlled trial (RCT) was
to compare these two options.
Methods
This was a mixed-methods multicentre study to establish the feasibility of
a RCT comparing oral feeding plus pre-treatment gastrostomy with oral feeding
plus as-required nasogastric tube feeding in patients with HNSCC. Patients were
recruited from four tertiary centres treating cancer and randomised to the two
arms of the study (using a 1 : 1 ratio). The eligibility criteria were patients
with advanced-staged HNSCC who were suitable for primary CRT with curative
intent and who presented with no swallowing problems.
Main outcome measures
The primary outcome was the willingness to be randomised. A qualitative
process evaluation was conducted alongside an economic modelling exercise. The
criteria for progression to a Phase III trial were based on a hypothesised
recruitment rate of at least 50%, collection of outcome measures in at least
80% of those recruited and an economic value-of-information analysis for
cost-effectiveness.
Results
Of the 75 patients approached about the trial, only 17 consented to be
randomised [0.23, 95% confidence interval (CI) 0.13 to 0.32]. Among those who
were randomised, the compliance rate was high (0.94, 95% CI 0.83 to 1.05).
Retention rates were high at completion of treatment (0.94, 95% CI 0.83 to
1.05), at the 3-month follow-up (0.88, 95% CI 0.73 to 1.04) and at the 6-month
follow-up (0.88, 95% CI 0.73 to 1.04). No serious adverse events were recorded
in relation to the trial. The qualitative substudy identified several factors
that had an impact on recruitment, many of which are amenable to change. These
included organisational factors, changing cancer treatments and patient and
clinician preferences. A key reason for the differential recruitment between
sites was the degree to which the multidisciplinary team gave a consistent
demonstration of equipoise at all patient interactions at which supplementary
feeding was discussed. An exploratory economic model generated from published
evidence and expert opinion suggests that, over the 6-month model time horizon,
pre-treatment gastrostomy tube feeding is not a cost-effective option, although
this should be interpreted with caution and we recommend that this should not
form the basis for policy. The economic value-of-information analysis indicates
that additional research to eliminate uncertainty around model parameters is
highly likely to be cost-effective.
Study limitations
The recruitment issues identified for this cohort may not be applicable to
other populations undergoing CRT. There remains substantial uncertainty in the
economic evaluation.
Conclusions
The trial did not meet one of the three criteria for progression, as the
recruitment rate was lower than hypothesised. Once patients were recruited to
the trial, compliance and retention in the trial were both high. The
implementation of organisational and operational measures can increase the
numbers recruited. The economic analysis suggests that further research in this
area is likely to be cost-effective.
Future work
The implementation of organisational and operational measures can increase
recruitment. The appropriate research question and design of a future study
needs to be identified. More work is needed to understand the experiences of
nasogastric tube feeding in patients undergoing CRT.
Trial registration
Current Controlled Trials ISRCTN48569216.
Funding
This project was funded by the National Institute for Health Research
(NIHR) Health Technology Assessment programme and will be published in full in
Health Technology Assessment; Vol. 22, No. 16.
See the NIHR Journals Library website for further project information.