Protocol for the SEHNeCa randomised clinical trial assesing Supervised Exercise for Head and Neck Cancer patients

Area of Science:

• Oncology
• Exercise Physiology
• Rehabilitation Medicine

Background:

• Head and neck cancer patients undergoing radiotherapy often experience loss of lean body mass, functional capacity, and reduced quality of life.
• Current management often involves autonomous physical activity plans, with limited evidence on the optimal timing of supervised exercise interventions.
• This study investigates a supervised exercise program's efficacy in mitigating negative impacts of radiotherapy.

Purpose of the Study:

• To evaluate the effectiveness of a supervised exercise program in preserving lean body mass, functional capacity, and quality of life in head and neck cancer patients.
• To determine the optimal timing for implementing the supervised exercise program: before or after radiotherapy.
• To compare the supervised program against a self-directed physical activity plan.

Main Methods:

• 144 patients with squamous cell carcinoma of the head and neck undergoing radiotherapy were randomized into three groups: pre-radiotherapy supervised exercise, post-radiotherapy supervised exercise, and autonomous exercise.
• The supervised exercise program consisted of 36 sessions over 12 weeks, combining moderate and high-intensity strength and aerobic exercises.
• Primary outcome: change in lean body mass at 6 months (bioimpedance). Secondary outcomes: functional capacity, symptoms, quality of life, and adverse effects. Longitudinal analysis using generalized mixed models at 3, 6, and 12 months.

Main Results:

• The pilot study demonstrated the feasibility and safety of the supervised exercise program.
• A notable decrease in session attendance was observed as the program progressed.
• Further analysis of primary and secondary outcomes is pending longitudinal data collection.

Conclusions:

• The supervised exercise program is feasible and safe for head and neck cancer patients.
• Strategies to enhance patient adherence and engagement are crucial for program success.
• Long-term follow-up will assess treatment toxicity and the program's response and adherence.