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Completed

NCT Number: NCT02439892

Rehabilitation for Head and Neck Cancer

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.

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Key information

Conditions

Head and Neck Neoplasms Behavior Health Behavior Motor Activity Neoplasms Neoplasms by Site Patient Acceptance of Health Care Patient Compliance Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LHL-klinikkene Røros, Røros, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise and nutrition during radiotherapy

Behavioral

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.

Multidimensional rehabilitation after radiotherapy

Behavioral

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.

Primary outcomes

  1. 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

  1. Preliminary effects on skeletal muscle mass as measured by computerized tomography at lumbar vertebra 3

    Time frame: 15 weeks

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • LHL-Klinikkene, Røros
  • Oslo University Hospital
  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 12, 2015
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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