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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
Sponsor:
Collaborators:
St. Olavs Hospital
LHL-Klinikkene, Røros
Oslo University Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Behavioral: Exercise and nutrition during radiotherapy Behavioral: Multidimensional rehabilitation after radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Preliminary effects on skeletal muscle mass as measured by computerized tomography at lumbar vertebra 3 [ Time Frame: 15 weeks ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Norway
LHL-klinikkene Røros
Røros, Norway, 7374
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
LHL-Klinikkene, Røros
Oslo University Hospital
Investigators
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Principal Investigator: Jo-Åsmund Lund, MD PhD St. Olavs Hospital
Principal Investigator: Stein Kaasa, prof MD Norwegian University of Science and Technology

Publications of Results:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02439892     History of Changes
Other Study ID Numbers: IDR-2012-01
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017

Keywords provided by Norwegian University of Science and Technology:
Radiotherapy
Exercise
Diet therapy
Rehabilitation
Patient Compliance
Feasibility Studies
Sample Size
Patient satisfaction

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms