Rehabilitation for Head and Neck Cancer

Not Applicable

Completed

• Conditions: Head and Neck Neoplasms
• Interventions: Behavioral: Exercise and nutrition during radiotherapy; Behavioral: Multidimensional rehabilitation after radiotherapy

• Registration Number: NCT02439892
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-12
• Primary Completion: 2017-04-01
• Study Completion: 2017-04-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early rehabilitation	Exercise and nutrition during radiotherapy	Exercise and nutrition during radiotherapy: Physical exercise, nutritional advice and oral nutritional supplements.
Late rehabilitation	Multidimensional rehabilitation after radiotherapy	Multidimensional rehabilitation after radiotherapy: Physical exercise, nutritional advice, oral nutritional supplements and patient education

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Preliminary effects on skeletal muscle mass as measured by computerized tomography at lumbar vertebra 3	15 weeks

Trial Locations

Locations (2)

LHL-klinikkene Røros; 🇳🇴 Røros, Norway

St Olavs Hospital; 🇳🇴 Trondheim, Norway