Progressive Resistance Training Program in Head and Neck Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: Progressive resistance training

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Dept. of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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).

Behavioral: Progressive resistance training; A 12-week, supervised, group based, progressive resistance training program involving the major muscle groups of the body will be tested. Details of the program: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	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.	up to 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LBM	Whole body LBM will be determined using dual energy x-ray absorptiometry (DXA).	up to 20 months
Weight loss	Patient will be weighed weekly during the 12-week PRT program; afterwards at each follow-up (2, 5, 9, and 13 months)	up to 20 months
Number of patients with side-effects to treatment	Side-effects will be registered using Common Terminology Criteria for Advers Events v4.0 (CTCAE).	up to 7 months
Quality of Life		Up to 20 months
Change in physical function and strength	Change in muscle strength will be evaluated by 1 repetition maximum test (1RM) measured in kg. Change in muscle power will be evaluated by Nottingham Power Rig and measured in watts and watt/kg. Change in physical function will be evaluated by 30 second sit-to-stand test, arm curl test and stair climbing.	Up to 20 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle biopsies	In order to establish energy-reserves in the muscles	up to 7 months
Blood samples	In order to identify systemic factors released during exercise	Up to 20 months

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Investigators: Principal Investigator: Julie Gehl, ph.d., Herlev Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 20, 2014
• First Posted (Estimate): February 21, 2014

Study Record Updates

• Last Update Posted (Estimate): September 25, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Exercise; Feasibility; Progressive resistance training; Weight loss; Body composition; Head and neck cancer; Concurrent chemoradiotherapy; LBM
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: HH1401