Clinical trial NCT02557529: Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy
Official title: Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy - The DAHANCA 31 Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Neoplasms
Weight Loss
Keywords: Head and Neck Cancer
Concomitant chemoradiotherapy
Exercise Training
Progressive Resistance Training
Weight loss
Lean Body Mass
Body Composition
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Odense University Hospital
name: Danish Head and Neck Cancer Group
First posted: 2015-09-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in LBM (lean body mass)
timeFrame: at 12-weeks post PRT
Secondary outcomes:
measure: Change in LBM (lean body mass)
timeFrame: at 6 weeks, and 6 and 12 months post RT
measure: Fat mass
timeFrame: at 6 and 12 weeks, and 6 and 12 months post RT
measure: Weight loss
timeFrame: at 6 and 12 weeks, and 6 and 12 months post RT
measure: Patient reported pain
timeFrame: at 6 and 12 weeks, and 6 and 12 months post RT
measure: Patient reported Quality of Life
timeFrame: at 6 and 12 weeks, and 6 and 12 months post RT
measure: Muscle strength
timeFrame: at 6 and 12 weeks, and 6 and 12 months post RT
measure: Chair rise
timeFrame: at 6 and 12 weeks, and 6 and 12 months post RT
measure: arm curls
timeFrame: at 6 and 12 weeks, and 6 and 12 months post RT
measure: Stair climb
timeFrame: at 6 and 12 weeks, 6 and 12 months
measure: Compliance to PRT program
timeFrame: at 12 weeks post PRT
measure: Physical activity
timeFrame: at 6 and 12 weeks, and 6 and 12 months post RT
measure: Percent of patients with feeding tubes
timeFrame: at 6 and 12 weeks, and 6 and 12 months post RT
measure: Resumption of work
timeFrame: At 12 months follow-up
measure: Percent relapses
timeFrame: at 12 months follow-up
measure: Cytokines
timeFrame: at 3, 6, 8, 10, and 12 weeks
measure: Muscle biopsies
timeFrame: at 6 and 12 weeks, and at 12 months follow-up
measure: Patient satisfaction
timeFrame: at 12 weeks
measure: NK-cells
timeFrame: at 3 and 12 weeks
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Oncology, Copenhagen University hospital, Herlev
Study officials:
affiliation: Herlev Hospital
name: Julie Gehl
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.