Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy

NCT ID: NCT02557529

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2020-01-31

Brief Summary

72 patients with head and neck cancer, undergoing primary treatment with radiation therapy and concomitant weekly cisplatin, will be recruited to this multicentre trial.

Randomized 1:1 to either 12-week progressive resistance training (PRT) program or control arm, starting together with concomitant chemoradiotherapy (CCRT) Stratified by centre, gender, p16-status and body mass index (BMI) below or above 30.

Primary endpoint is difference in change in lean body mass (LBM) between the groups and the endpoint is reduction of LBM loss in intervention arm by 25% compared to control.

Secondary endpoints include side-effects to treatment, change in body composition, physical function and strength, and compliance to PRT. Questionnaires on QoL, diet, voluntary exercise and work affiliation will also be registered.

Blood samples for explorative analyses will be drawn and optional muscle biopsies drawn for proteomics analyses and histological analyses.

Detailed Description

The PRT program will start about the onset of radiotherapy. The program consists of 7 exercises in training machines and involves 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. A pilot study (NCT02068950) showed feasibility of PRT during CCRT.

In addition to baseline data (height, tumor stage, performance status, etc), the following parameters will be registered: 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 6 and 12 months follow-up. DXA scans for body composition will be performed using a Lunar iDXA (GE Healthcare).

Blood samples will be drawn at regular intervals during the 12 weeks and at follow-up.

Patient reported quality of life (EORTC Quality of Life Questionnaire (QLQ)-C30 and QLQ-H&N35) will also be registered.

Muscle biopsies will be taken three times: at baseline, after treatment and after 12-weeks PRT.

Study duration is expected to be 18 months and an additional 12 months for follow-up.

Conditions

Head and Neck Neoplasms; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Progressive Resistance Training

12 weeks progressive resistance training (PRT) during and after concomitant chemoradiotherapy. Also optional/voluntary physical activity performed on their own is registered, as well as diet diary.

Group Type: EXPERIMENTAL

Progressive Resistance Training

Intervention Type: BEHAVIORAL

12 weeks supervised resistance training program. Details of the program: 12 weeks, 3 sessions per week, 7 exercises in training machines (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)

physical activity

Intervention Type: BEHAVIORAL

Weekly diary of performed physical activity using the Physical Activity Score (PAS) during the 12-weeks intervention

Diet diary

Intervention Type: BEHAVIORAL

Weekly diet diary during the 12-weeks intervention

Control

Control arm. Optional/voluntary physical activity performed on their own is registered, as well as diet diary.

Group Type: ACTIVE_COMPARATOR

physical activity

Intervention Type: BEHAVIORAL

Weekly diary of performed physical activity using the Physical Activity Score (PAS) during the 12-weeks intervention

Diet diary

Intervention Type: BEHAVIORAL

Weekly diet diary during the 12-weeks intervention

Interventions

Progressive Resistance Training

12 weeks supervised resistance training program. Details of the program: 12 weeks, 3 sessions per week, 7 exercises in training machines (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)

Intervention Type: BEHAVIORAL

physical activity

Weekly diary of performed physical activity using the Physical Activity Score (PAS) during the 12-weeks intervention

Intervention Type: BEHAVIORAL

Diet diary

Weekly diet diary during the 12-weeks intervention

Intervention Type: BEHAVIORAL

Other Intervention Names

Diary of performed physical activity

Eligibility Criteria

Inclusion Criteria

• Patients with biopsy verified head and neck squamous cell carcinoma referred for primary curatively intended treatment.
• Candidates for concomitant chemoradiotherapy (2Gyx33-34; 6F/W; weekly cisplatin 40mg/m2, max. 70 mg/weekly) according to Danish Head and Neck Cancer Group (DAHANCA) guidelines (T1-4, N1-3, M0)

• Performance status 0-1
• At least 18 years of age.

Exclusion Criteria

• BMI below 20.5
• diabetes
• corticosteroid treatment for other diseases
• Tonsillectomy within the last week before inclusion.
• hemoglobin below 6 mmol/l
• leucocytes below 2.5 x 10^9 /l
• thrombocytes below 50 x 10^9 /l
• comorbidities, social, familial or geographical conditions, that could compromise attendance or results

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

Danish Head and Neck Cancer Group

NETWORK

Sponsor Role: collaborator

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Julie Gehl

M.D., Dr. Med. Sci.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie Gehl

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital

Locations

Department of Oncology, Copenhagen University hospital, Herlev

Herlev, , Denmark

Countries

Denmark

References

Lonkvist CK, Lonbro S, Vinther A, Zerahn B, Rosenbom E, Primdahl H, Hojman P, Gehl J. Progressive resistance training in head and neck cancer patients during concomitant chemoradiotherapy -- design of the DAHANCA 31 randomized trial. BMC Cancer. 2017 Jun 3;17(1):400. doi: 10.1186/s12885-017-3388-0.

Reference Type: BACKGROUND

PMID: 28578654 (View on PubMed)

Other Identifiers

DAHANCA 31

Identifier Type: -

Identifier Source: org_study_id