Rehabilitation for Head and Neck Cancer

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439892
• Other study ID #: IDR-2012-01
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: April 1, 2017

Study information

• Verified date: April 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	LHL-klinikkene Røros	Røros
Norway	St Olavs Hospital	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	LHL-Klinikkene, Røros, Oslo University Hospital, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Sandmæl JA, Bye A, Solheim TS, Balstad TR, Thorsen L, Skovlund E, Kaasa S, Lund JÅ, Oldervoll L. Physical rehabilitation in patients with head and neck cancer: Impact on health-related quality of life and suitability of a post-treatment program. Laryngosc — View Citation

Sandmael JA, Bye A, Solheim TS, Stene GB, Thorsen L, Kaasa S, Lund JÅ, Oldervoll LM. Feasibility and preliminary effects of resistance training and nutritional supplements during versus after radiotherapy in patients with head and neck cancer: A pilot ran — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Preliminary effects on skeletal muscle mass as measured by computerized tomography at lumbar vertebra 3		15 weeks