Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-25 @ 2:47 PM
Study NCT ID:
NCT02068950
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2014-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Progressive Resistance Training Program in Head and Neck Cancer Patients
Sponsor:
Herlev Hospital
Organization:
Study Overview
Official Title:
Feasibility of a 12-week Progressive Resistance Training Program in Head and Neck Cancer Patients During Concurrent Radiochemotherapy - a Pilot Trial
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: