Rehabilitation During Versus After Radiotherapy in Head and Neck Cancer - a Pilot Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 41
- Locations
- 3
- Primary Endpoint
- Feasibility of interventions tracked by number of patients ineligible or refusing to participate, completion of interventions and attrition, adverse events and exercise/nutritional adherence.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Feasibility of interventions tracked by number of patients ineligible or refusing to participate, completion of interventions and attrition, adverse events and exercise/nutritional adherence.
Time Frame: 15 weeks
Secondary Outcomes
- Preliminary effects on skeletal muscle mass as measured by computerized tomography at lumbar vertebra 3(15 weeks)