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

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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

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.


Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Weight Loss Behavioral: Progressive Resistance Training Behavioral: physical activity Behavioral: Diet diary Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy - The DAHANCA 31 Study
Study Start Date : August 2015
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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




Primary Outcome Measures :
  1. Change in LBM (lean body mass) [ Time Frame: at 12-weeks post PRT ]
    change in kilograms


Secondary Outcome Measures :
  1. Change in LBM (lean body mass) [ Time Frame: at 6 weeks, and 6 and 12 months post RT ]
    change in kilograms

  2. Fat mass [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    change in kilograms

  3. Weight loss [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    in kilograms

  4. Patient reported pain [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    Measured by NRS-scale

  5. Patient reported Quality of Life [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    QLQ-C30 questionnaire

  6. Muscle strength [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    measured using chest press and leg press

  7. Chair rise [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    measured using 30 s. chair rise

  8. arm curls [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    measured using 30 s. arm curls

  9. Stair climb [ Time Frame: at 6 and 12 weeks, 6 and 12 months ]
    steps/sec

  10. Compliance to PRT program [ Time Frame: at 12 weeks post PRT ]
    No. of attended sessions out of total

  11. Physical activity [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
    measured by PAS (physical activity scale)

  12. Percent of patients with feeding tubes [ Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT ]
  13. 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)

  14. Percent relapses [ Time Frame: at 12 months follow-up ]
    Percent of patients having relapse within 12 months after radiotherapy

  15. 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.

  16. 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.

  17. Patient satisfaction [ Time Frame: at 12 weeks ]
    Study specific questionnaire regarding pros and cons of attending the study

  18. NK-cells [ Time Frame: at 3 and 12 weeks ]
    Measuring NK-cells. NK-cells may increase after exercise and show tumor inhibiting effect.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557529


Locations
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Denmark
Department of Oncology, Copenhagen University hospital, Herlev
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Aarhus University Hospital
Odense University Hospital
Danish Head and Neck Cancer Group
Investigators
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Principal Investigator: Julie Gehl Herlev Hospital
Publications:
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Responsible Party: Julie Gehl, M.D., Dr. Med. Sci., Herlev Hospital
ClinicalTrials.gov Identifier: NCT02557529    
Other Study ID Numbers: DAHANCA 31
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Keywords provided by Julie Gehl, Herlev Hospital:
Head and Neck Cancer
Concomitant chemoradiotherapy
Exercise Training
Progressive Resistance Training
Weight loss
Lean Body Mass
Body Composition
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Weight Loss
Neoplasms by Site
Neoplasms
Body Weight Changes
Body Weight
Signs and Symptoms