Clinical trial NCT02068950: Progressive Resistance Training Program in Head and Neck Cancer Patients
Official title: Feasibility of a 12-week Progressive Resistance Training Program in Head and Neck Cancer Patients During Concurrent Radiochemotherapy - a Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Head and neck cancer
Concurrent chemoradiotherapy
Progressive resistance training
Exercise
Feasibility
Weight loss
LBM
Body composition
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the feasibility of a 12-week progressive resistance training (PRT) during concurrent chemoradiotherapy in head and neck cancer patients compared to usual care.

Detailed description: 12 patients with head and neck cancer will be recruited to this trial. Entering a 12-week PRT program which will start one week before radiotherapy. The tested training program is a 12-week, supervised, group based, progressive resistance training program involving the major muscle groups of the body. The program has previously been found to successfully restore the loss of lean body mass (LBM) in head and neck cancer patients post-treatment. A group based approach will be used to facilitate a social and motivating training environment for the patients. This approach has previously been used for exercise interventions for lung cancer patients at our facility, and was highly appreciated by the patients.

In addition to baseline data (height, tumor stage, performance status, etc), the following parameters will be registered on a weekly basis: Weight, patient reported side effects, as well as a questionnaire on amount of physical activity and food intake.

Physical function and strength will be tested at baseline, after the course of chemoradiotherapy and at the end of the 12-week PRT programme, and at 2, 5, 9 and 13 months follow-up. At similar time points dual energy x-ray absorptiometry (DXA) scans for body composition will be performed using a Lunar iDXA (GE Healthcare).

Blood samples will be drawn at baseline, an additional three times during the first 6 weeks and then weekly in relation to training sessions, and at 2, 5, 9 and 13 months follow-up.

Patient reported quality of life (EORTC Quality of Life Questionaire (QLQ)-C30 and QLQ-H\&N35) will be registered at baseline, after 12-weeks PRT and during 5 and 13 months follow-up.

Study duration is expected to be 7 months for the pilot-trial, with a follow-up of additional 13 months after the last patient has completed the intervention.

Eligibility criteria: Inclusion Criteria:

* Patients with head and neck squamous cell carcinoma
* Candidates for concomitant chemoradiotherapy according to Danish Head and Neck Cancer Group (DAHANCA) guidelines.
* Performance status 0-1
* Expected to be able to complete the intervention, i.e. no major comorbidities or social issues that could compromise attendance.
* At least 18 years of age.

Primary outcomes:
measure: Feasibility
timeFrame: up to 7 months
Secondary outcomes:
measure: Change in LBM
timeFrame: up to 20 months
measure: Weight loss
timeFrame: up to 20 months
measure: Number of patients with side-effects to treatment
timeFrame: up to 7 months
measure: Quality of Life
timeFrame: Up to 20 months
measure: Change in physical function and strength
timeFrame: Up to 20 months
Other outcomes:
measure: Muscle biopsies
timeFrame: up to 7 months
measure: Blood samples
timeFrame: Up to 20 months
Locations:
city: Herlev
country: Denmark
facility: Dept. of Oncology
Study officials:
affiliation: Herlev Hospital
name: Julie Gehl, ph.d.
role: PRINCIPAL_INVESTIGATOR
References: