Head and Neck Cancer Clinical Trial
Official title:
Feasibility of a 12-week Progressive Resistance Training Program in Head and Neck Cancer Patients During Concurrent Radiochemotherapy - a Pilot Trial
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.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label
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