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Head and Neck NeoplasmsNCT02557529

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

A study testing Progressive Resistance Training, physical activity and Diet diary in people with Head and Neck Neoplasms and Weight Loss, run by Herlev Hospital at 1 site in Denmark.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Neoplasms, Weight Loss
What is being tested?
Progressive Resistance Training, physical activity and Diet diary
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteDenmark
Study dates
Aug 2015to Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Oncology, Copenhagen University hospital, Herlev

    Herlev, 2730

Other trials in Denmark

About this study

Official title: Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy - The DAHANCA 31 Study

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.

Read more

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.

Read the 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.

Being tested
Progressive Resistance Training, physical activity, Diet diary
Keywords
Head and Neck Cancer, Concomitant chemoradiotherapy, Exercise Training, Progressive Resistance Training, Weight loss, Lean Body Mass, Body Composition
Medical subject headings
Head and Neck Neoplasms, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive Resistance TrainingBehavioural

    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 activityBehavioural

    Also called Diary of performed physical activity

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

  • Diet diaryBehavioural

    Weekly diet diary during the 12-weeks intervention

Study groups in NCT02557529
Study groupRoleWhat they receive
Progressive Resistance TrainingExperimental12 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.
Receives: Behavioral: Progressive Resistance Training; Behavioral: physical activity; Behavioral: Diet diary
ControlActive comparatorControl arm. Optional/voluntary physical activity performed on their own is registered, as well as diet diary.
Receives: Behavioral: physical activity; Behavioral: Diet diary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in LBM (lean body mass)

    change in kilograms

    Measured: at 12-weeks post PRT

Secondary outcomes (18)

  1. Change in LBM (lean body mass)

    change in kilograms

    Measured: at 6 weeks, and 6 and 12 months post RT

  2. Fat mass

    change in kilograms

    Measured: at 6 and 12 weeks, and 6 and 12 months post RT

  3. Weight loss

    in kilograms

    Measured: at 6 and 12 weeks, and 6 and 12 months post RT

  4. Patient reported pain

    Measured by NRS-scale

    Measured: at 6 and 12 weeks, and 6 and 12 months post RT

  5. Patient reported Quality of Life

    QLQ-C30 questionnaire

    Measured: at 6 and 12 weeks, and 6 and 12 months post RT

  6. Muscle strength

    measured using chest press and leg press

    Measured: at 6 and 12 weeks, and 6 and 12 months post RT

  7. Chair rise

    measured using 30 s. chair rise

    Measured: at 6 and 12 weeks, and 6 and 12 months post RT

  8. arm curls

    measured using 30 s. arm curls

    Measured: at 6 and 12 weeks, and 6 and 12 months post RT

  9. Stair climb

    steps/sec

    Measured: at 6 and 12 weeks, 6 and 12 months

  10. Compliance to PRT program

    No. of attended sessions out of total

    Measured: at 12 weeks post PRT

  11. Physical activity

    measured by PAS (physical activity scale)

    Measured: at 6 and 12 weeks, and 6 and 12 months post RT

  12. Percent of patients with feeding tubes

    Measured: at 6 and 12 weeks, and 6 and 12 months post RT

  13. Resumption of work

    No. of days from end of radiotherapy until back at work at full time (or the hours of work per week as before therapy)

    Measured: At 12 months follow-up

  14. Percent relapses

    Percent of patients having relapse within 12 months after radiotherapy

    Measured: at 12 months follow-up

  15. Cytokines

    Measurement of different cytokines, changes over time and after bout of PRT. Will be measured regularly during the 12 weeks of PRT.

    Measured: at 3, 6, 8, 10, and 12 weeks

  16. Muscle biopsies

    protein will be measured using the proteomic approach. Muscle fiber type and size will be evaluated.

    Measured: at 6 and 12 weeks, and at 12 months follow-up

  17. Patient satisfaction

    Study specific questionnaire regarding pros and cons of attending the study

    Measured: at 12 weeks

  18. NK-cells

    Measuring NK-cells. NK-cells may increase after exercise and show tumor inhibiting effect.

    Measured: at 3 and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJan 2020
  4. Study completionJan 2020

Why it stopped: Slow recruition

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02557529
Sponsor's protocol ID
DAHANCA 31
Status last verified
May 2020
First submitted
11 Sep 2015
Last updated
27 May 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28578654

Questions about this trial

What is this clinical trial studying?

A study testing Progressive Resistance Training, physical activity and Diet diary in people with Head and Neck Neoplasms and Weight Loss, run by Herlev Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Slow recruition). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in LBM (lean body mass) (time frame: at 12-weeks post PRT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02557529, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.

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