Rehabilitation for Head and Neck Cancer

Norwegian University of Science and Technology

Status: Completed

Conditions: Head and Neck Neoplasms

Treatments: Behavioral: Multidimensional rehabilitation after radiotherapy; Behavioral: Exercise and nutrition during radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02439892

IDR-2012-01

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Early rehabilitation

Experimental group

Description:

Exercise and nutrition during radiotherapy: Physical exercise, nutritional advice and oral nutritional supplements.

Treatment:

Behavioral: Exercise and nutrition during radiotherapy

Late rehabilitation

Active Comparator group

Description:

Multidimensional rehabilitation after radiotherapy: Physical exercise, nutritional advice, oral nutritional supplements and patient education

Treatment:

Behavioral: Multidimensional rehabilitation after radiotherapy