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Rehabilitation for Head and Neck Cancer

Primary Purpose

Head and Neck Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise and nutrition during radiotherapy
Multidimensional rehabilitation after radiotherapy
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Neoplasms focused on measuring Radiotherapy, Exercise, Diet therapy, Rehabilitation, Patient Compliance, Feasibility Studies, Sample Size, Patient satisfaction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LHL-klinikkene Røros
  • St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early rehabilitation

Late rehabilitation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Feasibility of interventions tracked by number of patients ineligible or refusing to participate, completion of interventions and attrition, adverse events and exercise/nutritional adherence.

Secondary Outcome Measures

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

Full Information

First Posted
April 22, 2015
Last Updated
April 28, 2020
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, LHL-Klinikkene, Røros, Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02439892
Brief Title
Rehabilitation for Head and Neck Cancer
Official Title
Rehabilitation During Versus After Radiotherapy in Head and Neck Cancer - a Pilot Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, LHL-Klinikkene, Røros, Oslo University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
Radiotherapy, Exercise, Diet therapy, Rehabilitation, Patient Compliance, Feasibility Studies, Sample Size, Patient satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early rehabilitation
Arm Type
Experimental
Arm Description
Exercise and nutrition during radiotherapy: Physical exercise, nutritional advice and oral nutritional supplements.
Arm Title
Late rehabilitation
Arm Type
Active Comparator
Arm Description
Multidimensional rehabilitation after radiotherapy: Physical exercise, nutritional advice, oral nutritional supplements and patient education
Intervention Type
Behavioral
Intervention Name(s)
Exercise and nutrition during radiotherapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multidimensional rehabilitation after radiotherapy
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Preliminary effects on skeletal muscle mass as measured by computerized tomography at lumbar vertebra 3
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo-Åsmund Lund, MD PhD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stein Kaasa, prof MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
LHL-klinikkene Røros
City
Røros
ZIP/Postal Code
7374
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
28759113
Citation
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.
Results Reference
result
PubMed Identifier
32337365
Citation
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.
Results Reference
result

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Rehabilitation for Head and Neck Cancer

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