Feasibility of a 12-week Progressive Resistance Training Program in Head and Neck Cancer Patients During Concurrent Radiochemotherapy - a Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Herlev Hospital
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Feasibility
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Arms & Interventions
Progressive resistance training
12 weeks, 3 sessions per week, 7 exercises (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions). In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand).
Intervention: Progressive resistance training (Behavioral)
Outcomes
Primary Outcomes
Feasibility
Time Frame: up to 7 months
The feasibility outcomes will be inclusion rate defined as the number of patients recruited from the number of eligible patients and completion rate defined as the number of participants able to complete the intervention. Adherence to the exercise intervention will be evaluated via patient-reported training logs.
Secondary Outcomes
- Number of patients with side-effects to treatment(up to 7 months)
- Change in physical function and strength(Up to 20 months)
- Weight loss(up to 20 months)
- Quality of Life(Up to 20 months)
- Change in LBM(up to 20 months)
Investigators
Julie Gehl
Senior Consultant, ph.d.
Herlev Hospital