EffEx-HN trial: study protocol for a randomized controlled trial on the EFFectiveness and feasibility of a comprehensive supervised EXercise program during radiotherapy in Head and Neck cancer patients on health-related quality of life

Background With over 500,000 annually reported cases worldwide, head and neck cancer (HNC) is the seventh most common type of cancer worldwide.

Treatment of HNC with chemoradiotherapy frequently results in serious impairments in physical and psychosocial functioning.

Besides, HNC patients typically start their cancer treatment already with poor physical and psychosocial health.

It has been shown that a sufficient level of physical activity (PA) before, during, and after cancer treatment is associated with fewer negative treatment-related side effects and a better quality of life (QOL).

In order to prevent worsening of functioning and limit the physical impact of the HNC treatment, a comprehensive supervised exercise program (CSEP) may be beneficial during early cancer treatment.

However, up to now, the feasibility and effectiveness of such a program are not yet investigated thoroughly in HNC.

Therefore, the primary objective of this study is to examine the effectiveness of a CSEP during HNC treatment, in addition to usual supportive care, compared to usual supportive care alone, on health-related QOL up to 1 year post-diagnosis.

Secondary objectives entail gathering information on (1) the effectiveness of a CSEP on secondary outcomes such as physical and mental function, activities of daily life, and participation in society and (2) the feasibility, possible barriers, and facilitators for participation in a CSEP during HNC treatment.

Methods To investigate the effectiveness of the CSEP, a parallel, open-label randomized controlled trial will be performed.

To study the feasibility of the CSEP, a mixed-method study will be performed in a subgroup of participants.

HNC patients are eligible if they receive radiotherapy at the Radiation-Oncology department of the University Hospital of Leuven.

A 4-size permuted block randomization will be used.

The control group receives the current standard of supportive care.

The intervention group receives a CSEP, additional to the same usual supportive care.

The CSEP consists of a 12-week intensive phase with 3 exercise sessions of 1 h per week, where supervision is gradually reduced after 6 weeks.

During the maintenance phase (from week 13), patients exercise at home with monthly tele-consultations with a physiotherapist.

The CSEP contains supervised aerobic and resistance training.

In both groups, outcomes of interest are evaluated through self-reported questionnaires and clinical assessments, at baseline, 6 weeks, 12 weeks, 6 months, and 12 months post-diagnosis.

The primary endpoint is health-related QOL, measured with the EORTC QLQ-C30 at 6 months post-diagnosis.

Discussion The study will be conducted in accordance with the Declaration of Helsinki.

This protocol has been approved by the ethical committee of the University Hospitals Leuven (s65549).

Recruitment started in January 2022.

Results will be disseminated via peer-reviewed scientific journals and presentations at congresses.

Trial registration Trial Registration: ClinicalTrials.gov Identifier: NCT05256238 Date of registration: February 25, 2022