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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557529
Recruitment Status : Terminated (Slow recruition)
First Posted : September 23, 2015
Last Update Posted : May 27, 2020
Sponsor:
Collaborators:
Aarhus University Hospital
Odense University Hospital
Danish Head and Neck Cancer Group
Information provided by (Responsible Party):
Julie Gehl, Herlev Hospital

Tracking Information
First Submitted Date  ICMJE September 11, 2015
First Posted Date  ICMJE September 23, 2015
Last Update Posted Date May 27, 2020
Study Start Date  ICMJE August 2015
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
Change in LBM (lean body mass) [ Time Frame: at 12-weeks post PRT ]
change in kilograms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2019)
  • Change in LBM (lean body mass) [ Time Frame: at 6 weeks, and 6 and 12 months post RT ]
    change in kilograms
  • Fat mass [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    change in kilograms
  • Weight loss [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    in kilograms
  • Patient reported pain [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    Measured by NRS-scale
  • Patient reported Quality of Life [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    QLQ-C30 questionnaire
  • Muscle strength [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    measured using chest press and leg press
  • Chair rise [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    measured using 30 s. chair rise
  • arm curls [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    measured using 30 s. arm curls
  • Stair climb [ Time Frame: at 6 and 12 weeks, 6 and 12 months ]
    steps/sec
  • Compliance to PRT program [ Time Frame: at 12 weeks post PRT ]
    No. of attended sessions out of total
  • Physical activity [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    measured by PAS (physical activity scale)
  • Percent of patients with feeding tubes [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
  • Resumption of work [ Time Frame: At 12 months follow-up ]
    No. of days from end of radiotherapy until back at work at full time (or the hours of work per week as before therapy)
  • Percent relapses [ Time Frame: at 12 months follow-up ]
    Percent of patients having relapse within 12 months after radiotherapy
  • Cytokines [ Time Frame: at 3, 6, 8, 10, and 12 weeks ]
    Measurement of different cytokines, changes over time and after bout of PRT. Will be measured regularly during the 12 weeks of PRT.
  • Muscle biopsies [ Time Frame: at 6 and 12 weeks, and at 12 months follow-up ]
    protein will be measured using the proteomic approach. Muscle fiber type and size will be evaluated.
  • Patient satisfaction [ Time Frame: at 12 weeks ]
    Study specific questionnaire regarding pros and cons of attending the study
  • NK-cells [ Time Frame: at 3 and 12 weeks ]
    Measuring NK-cells. NK-cells may increase after exercise and show tumor inhibiting effect.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
  • Change in LBM (lean body mass) [ Time Frame: at 6 weeks, and 6 and 12 months post RT ]
    change in kilograms
  • Fat mass [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    change in kilograms
  • Weight loss [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    in kilograms
  • pain [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    Measured by NRS-scale
  • Quality of Life [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    QLQ-C30 questionnaire
  • Muscle strength [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    measured using chest press and leg press
  • Chair rise [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    measured using 30 s. chair rise
  • arm curls [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    measured using 30 s. arm curls
  • Stair climb [ Time Frame: at 6 and 12 weeks, 6 and 12 months ]
    steps/sec
  • Compliance to PRT program [ Time Frame: at 12 weeks post PRT ]
    No. of attended sessions out of total
  • Physical activity [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    measured by PAS (physical activity scale)
  • Percent of patients with feeding tubes [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
  • Resumption of work [ Time Frame: At 12 months follow-up ]
    No. of days from end of radiotherapy until back at work at full time (or the hours of work per week as before therapy)
  • Percent relapses [ Time Frame: at 12 months follow-up ]
    Percent of patients having relapse within 12 months after radiotherapy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy
Official Title  ICMJE Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy - The DAHANCA 31 Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Head and Neck Neoplasms
  • Weight Loss
Intervention  ICMJE
  • Behavioral: 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)
  • Behavioral: physical activity
    Weekly diary of performed physical activity using the Physical Activity Score (PAS) during the 12-weeks intervention
    Other Name: Diary of performed physical activity
  • Behavioral: Diet diary
    Weekly diet diary during the 12-weeks intervention
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Behavioral: Progressive Resistance Training
    • Behavioral: physical activity
    • Behavioral: Diet diary
  • Active Comparator: Control
    Control arm. Optional/voluntary physical activity performed on their own is registered, as well as diet diary.
    Interventions:
    • Behavioral: physical activity
    • Behavioral: Diet diary
Publications * Lonkvist CK, Lønbro 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 23, 2020)
50
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2015)
72
Actual Study Completion Date  ICMJE January 2020
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02557529
Other Study ID Numbers  ICMJE DAHANCA 31
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julie Gehl, Herlev Hospital
Study Sponsor  ICMJE Herlev Hospital
Collaborators  ICMJE
  • Aarhus University Hospital
  • Odense University Hospital
  • Danish Head and Neck Cancer Group
Investigators  ICMJE
Principal Investigator: Julie Gehl Herlev Hospital
PRS Account Herlev Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP