Progressive Resistance Training Program in Head and Neck Cancer Patients

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068950
• Other study ID #: HH1401
• Status: Completed
• Phase: N/A
• First received: February 13, 2014
• Last updated: September 23, 2015
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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)

Locations

Country	Name	City	State
Denmark	Dept. of Oncology	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Muscle biopsies	In order to establish energy-reserves in the muscles	up to 7 months	No
Other	Blood samples	In order to identify systemic factors released during exercise	Up to 20 months	No
Primary	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	No
Secondary	Change in LBM	Whole body LBM will be determined using dual energy x-ray absorptiometry (DXA).	up to 20 months	No
Secondary	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	No
Secondary	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	No
Secondary	Quality of Life		Up to 20 months	No
Secondary	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	No