Rehabilitation for Head and Neck Cancer

Study Overview
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Brief Summary
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Patients treated for head and neck cancer (HNC) suffer from severe side-effects such as pain and difficulties in swallowing, often leading to weight loss. More than 70 % of the weight loss is attributed to lean muscle wasting that is associated with decline in physical function, substantial fatigue and significantly decreased quality of life. Rehabilitation that includes physical exercise, nutritional counselling and oral nutritional supplements (ONS) can potentially reduce or prevent muscle wasting. The primary aim of this pilot randomised trial is to assess feasibility, evaluate patient experiences and assess preliminary effects on muscle mass, physical function, nutritional status and quality of life of rehabilitation interventions during and after radiotherapy (RT). Newly diagnosed HNC patients referred for curative RT with or without chemotherapy, will be randomised to a) rehabilitation during RT or b) rehabilitation after RT. Rehabilitation during RT will be carried out at an outpatient facility during the treatment period (6-7 weeks) and rehabilitation after RT will be carried at a rehabilitation centre and last for 3 weeks.

Official Title
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Rehabilitation During Versus After Radiotherapy in Head and Neck Cancer - a Pilot Randomised Controlled Trial

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Behavioral: Exercise and nutrition during radiotherapy
* Behavioral: Multidimensional rehabilitation after radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of squamous cell cancer (SCC) originated in the head/neck (naso, oro, hypo pharynx, larynx and oral cavity) Due to commence curative radiotherapy (RT) or chemoradiotherapy (CRT) All baseline assessments can be completed within 4 weeks prior to first cycle of RT or CRT Written informed consent is present willing to comply with study procedures Exclusion Criteria: stage T1N0M0 laryngeal cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early rehabilitation<br>Exercise and nutrition during radiotherapy: Physical exercise, nutritional advice and oral nutritional supplements. | Behavioral: Exercise and nutrition during radiotherapy<br>* The intervention consists of physical exercise, nutritional counselling and supplements. The exercise sessions will be conducted twice a week for 30 minutes each time during the RT treatment period, and include a main part of progressive resistance training (PRT). The PRT will be conducted by conventional upper and lower body exercises at a load of 60 - 80 % of 1 repetition maximum (RM) in 3-4 sets of 6-12 repetitions. The patients will receive nutritional information and dietary advice, and up to 2 energy dense oral nutritional supplements (ONS) daily. A nutrition interview will be conducted at study baseline and individual goals and targets will be set during the first counselling and monitored during the intervention period.<br>|
| Active Comparator: Late rehabilitation<br>Multidimensional rehabilitation after radiotherapy: Physical exercise, nutritional advice, oral nutritional supplements and patient education | Behavioral: Multidimensional rehabilitation after radiotherapy<br>* The intervention consists of physical exercise, nutritional counselling and supplements and patient education. The exercise sessions will be conducted 3 times a week for 45 minutes each time during the 3 week rehabilitation programme, and include a main part of progressive resistance training (PRT). PRT will be conducted as described in the intervention during treatment. The nutritional intervention will be carried out as described in the intervention during treatment. Patient education will be run as 45-60 minutes lecture/group discussion on relevant topics, lead by health professionals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of interventions tracked by number of patients ineligible or refusing to participate, completion of interventions and attrition, adverse events and exercise/nutritional adherence. |  | 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary effects on skeletal muscle mass as measured by computerized tomography at lumbar vertebra 3 |  | 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Exercise, Diet therapy, Rehabilitation, Patient Compliance, Feasibility Studies, Sample Size, Patient satisfaction