Rehabilitation for Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT02439892|
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : August 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms||Behavioral: Exercise and nutrition during radiotherapy Behavioral: Multidimensional rehabilitation after radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Rehabilitation During Versus After Radiotherapy in Head and Neck Cancer - a Pilot Randomised Controlled Trial|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||April 1, 2017|
|Actual Study Completion Date :||April 1, 2017|
Experimental: Early rehabilitation
Exercise and nutrition during radiotherapy: Physical exercise, nutritional advice and oral nutritional supplements.
Behavioral: Exercise and nutrition during radiotherapy
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.
Active Comparator: Late rehabilitation
Multidimensional rehabilitation after radiotherapy: Physical exercise, nutritional advice, oral nutritional supplements and patient education
Behavioral: Multidimensional rehabilitation after radiotherapy
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.
- 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 ]
- Preliminary effects on skeletal muscle mass as measured by computerized tomography at lumbar vertebra 3 [ Time Frame: 15 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439892
|Røros, Norway, 7374|
|St Olavs Hospital|
|Principal Investigator:||Jo-Åsmund Lund, MD PhD||St. Olavs Hospital|
|Principal Investigator:||Stein Kaasa, prof MD||Norwegian University of Science and Technology|