Rehabilitation for Head and Neck Cancer

NCT02439892 | Completed DMC

• 1 other identifier: IDR-2012-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Neoplasms

Keywords

Radiotherapy; Exercise; Diet therapy; Rehabilitation; Patient Compliance; Feasibility Studies; Sample Size; Patient satisfaction

Outcome Measures

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.

  15 weeks

Secondary Outcomes (1)

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

  15 weeks

Study Arms (2)

Early rehabilitation

EXPERIMENTAL

Exercise and nutrition during radiotherapy: Physical exercise, nutritional advice and oral nutritional supplements.

Behavioral: Exercise and nutrition during radiotherapy

Late rehabilitation

ACTIVE COMPARATOR

Multidimensional rehabilitation after radiotherapy: Physical exercise, nutritional advice, oral nutritional supplements and patient education

Behavioral: Multidimensional rehabilitation after radiotherapy

Interventions

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.

Early rehabilitation

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.

Late rehabilitation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• stage T1N0M0 laryngeal cancer

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• LHL-Klinikkene, Røros: collaborator
• Oslo University Hospital: collaborator

Study Sites (2)

LHL-klinikkene Røros

Røros, 7374, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

• Sandmael JA, Bye A, Solheim TS, Stene GB, Thorsen L, Kaasa S, Lund JA, 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 randomized trial. Cancer. 2017 Nov 15;123(22):4440-4448. doi: 10.1002/cncr.30901. Epub 2017 Jul 31.

  PMID: 28759113 RESULT

• Sandmael JA, Bye A, Solheim TS, Balstad TR, Thorsen L, Skovlund E, Kaasa S, Lund JA, 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. Laryngoscope Investig Otolaryngol. 2020 Mar 17;5(2):330-338. doi: 10.1002/lio2.368. eCollection 2020 Apr.

  PMID: 32337365 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Motor Activity; Patient Compliance; Patient Satisfaction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jo-Åsmund Lund, MD PhD

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

• Stein Kaasa, prof MD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: May 12, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

NO (2)