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Nutritional prehabilitation in head and neck cancer patients (PreHead) - A randomized controlled trial study protocol
D Sijbrands1, D Gort-van Dijk2, S A H J de Visscher3
1Department of Otorhinolaryngology and Head and Neck Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Rationale:
Up to 60% of patients with head and neck cancer are malnourished upon first presentation. Malnutrition has been associated with a higher risk of adverse events and decreased quality of life and survival. Patients with a high risk of malnutrition often receive pretreatment dietary treatment before surgery or (chemo)radiotherapy, i.e., nutritional prehabilitation. However, previous research suggests that patients with a low or medium risk of malnutrition may also benefit from nutritional prehabilitation.
Objective:
To investigate the effect of nutritional prehabilitation on adverse events, nutritional status, patient-reported quality of life, tumor recurrence, and (disease-specific and overall) survival. To evaluate the cost-effectiveness of nutritional prehabilitation compared with standard care.
Study Design:
A single-center, non-blinded, randomized controlled trial.
Study Population:
Patients with locoregionally advanced stage (III or IV) primary mucosal squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx treated with curative intent and with a low or medium risk of malnutrition according to the Malnutrition Universal Screening tool.
Sample Size:
Based on a power analysis, a total of 128 patients will be included.
Intervention:
The intervention arm will receive nutritional prehabilitation and the control arm will receive standard care (no nutritional prehabilitation).
Main Study Parameters/Endpoints:
Adverse events (i.e., surgical complications and (chemo)radiotherapy toxicity). Complications will be measured within 30 days after surgery using the Clavien-Dindo classification. Toxicity will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), 6 and 12 weeks after the start of (chemo)radiotherapy.
Significance:
It is hypothesized that nutritional prehabilitation, compared with no nutritional prehabilitation, will result in fewer (severe) adverse events, improvement of nutritional status, higher quality of life, equal risk of recurrence and better survival. It is hypothesized that the intervention will be cost-effective.
Trial Registration:
The trial is registered in the Dutch Trial Register under registration number NL87676.042.24.
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