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Completed

NCT Number: NCT02068950

Progressive Resistance Training Program in Head and Neck Cancer Patients

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.

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Key information

Conditions

Head and Neck Cancer Behavior Body Weight Body Weight Changes Head and Neck Neoplasms Motor Activity Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Oncology

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Progressive resistance training

Behavioral

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)

Primary outcomes

  1. 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

  1. Change in LBM

    Time frame: up to 20 months

    Whole body LBM will be determined using dual energy x-ray absorptiometry (DXA).

  2. Weight loss

    Time frame: up to 20 months

    Patient will be weighed weekly during the 12-week PRT program; afterwards at each follow-up (2, 5, 9, and 13 months)

  3. Number of patients with side-effects to treatment

    Time frame: up to 7 months

    Side-effects will be registered using Common Terminology Criteria for Advers Events v4.0 (CTCAE).

  4. Quality of Life

    Time frame: Up to 20 months

  5. Change in physical function and strength

    Time frame: Up to 20 months

    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.

Other outcomes

  1. Muscle biopsies

    Time frame: up to 7 months

    In order to establish energy-reserves in the muscles

  2. Blood samples

    Time frame: Up to 20 months

    In order to identify systemic factors released during exercise

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

Feasibility of a 12-week Progressive Resistance Training Program in Head and Neck Cancer Patients During Concurrent Radiochemotherapy - a Pilot Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 21, 2014
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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