NeoplasmsNCT02192216
The Effect of Resistance Training and Aerobic Training on Body Composition During Chemotherapy
A study testing Exercise in people with Neoplasms, run by Department of Public Health, Denmark at 1 site in Denmark.
Trial summary
Chemotherapy can induce muscle loss in colorectal, breast and advanced renal cell carcinoma patients. The Danish nation-wide training and rehabilitation offer 'Body \& Cancer' offers intensive resistance and endurance training to all Danish cancer patients receiving chemotherapy with the aim of reducing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Dec 2016
- 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
- Currently receiving curative, adjuvant, neo-adjuvant or palliative chemotherapy
- No documented bone metastases or myelomatosis
- No documented CNS affection
- WHO performance status 0-1
- No chronical thrombocytopenia or leukopenia
- No physical conditions preventing exercise participation
Show all 10Show fewer
- No serious symptoms of heart disease
- No dementia or mental illness preventing participation
- Signed written concent
- Age above 18 years
Who cannot join
- Participation in systematic resistance training three months prior to inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Chemotherapy can induce muscle loss in colorectal, breast and advanced renal cell carcinoma patients. The Danish nation-wide training and rehabilitation offer 'Body \& Cancer' offers intensive resistance and endurance training to all Danish cancer patients receiving chemotherapy with the aim of reducing treatment-related fatigue and physical impairments, but the potential of the training to preserve or improve muscle mass is uninvestigated.
Furthermore, the underlying biological mechanisms of treatment and/or exercise induced changes in muscle mass in cancer patients remains uninvestigated.
Read more
Thus, the primary purpose of the present study is to investigate changes in body composition during chemotherapy and after resistance and aerobic training combined with protein supplementation during ongoing chemotherapy in cancer patients. Secondly, we aim to investigate the underlying biological mechanisms of muscle mass regulation in biopsies obtained before and after a control period as well as after 10 weeks of exercise, both during chemotherapy.
We hypothesize that 10 weeks exercise will improve muscle mass and body composition in cancer patients during chemotherapy as compared to a control period during chemotherapy alone.
- Conditions
- Neoplasms
- Being tested
- Exercise
- Keywords
- Body composition, Chemotherapy, Muscle mass, Muscle function, Exercise
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Resistance training, Aerobic exercise, Protein supplementation
| Study group | Role | What they receive |
|---|---|---|
| Exercise & Chemotherapy | Experimental | Following a control period during active chemotherapy the patients undergo ten weeks of supervised exercise comprised of resistance and aerobic training in combination with protein supplementation during ongoing chemotherapy. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body composition
Changes in lean body mass and fat mass wil be assessed using Dual Energy X-Ray Absorptiometry
Measured: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
Secondary outcomes (5)
Changes in underlying biological mechanisms associated with changes in muscle mass
Analyzed from muscle biopsies from m. vastus lateralis and venous blood samples
Measured: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
Changes in dynamic muscle strength
Changes in muscle strength will be assessed using 1 repetition maximum (kg) tests using conventional training equipment.
Measured: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
Changes in aerobic performance
Changes in aerobic performance will be assessed using the Watt max bicycle ergometer test. Maximal oxygen consumption (L O2 pr min) will be estimated based on this test.
Measured: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
Changes in cancer related fatigue and quality of life
Changes in cancer related fatigue and quality of life wil be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) questionaire QLQ C30
Measured: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
Changes in functional performance
Changes in functional performance will be assessed using various validated functional performance tests. Thus, changes will be asssessed in 30 s arm curl test (max repetitions) , 30 s chair rise test (max repetitions), stair climbing test (time to ascend to flights of stairs), 10 m maximal gait speed test (time to walk 10 m as fast as possible).
Measured: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionDec 2016
Why it stopped: Recruiting issues and limited personel ressources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Public Health, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Simon Lønbro, Department of Public Health, Denmark
- Investigators
- Simon Loenbro, M.Sc., PhD, Principal investigator, Dept. of Public Health, Sect. for Sports Science, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192216
- Sponsor's protocol ID
- SKDM2014
- Other IDs
- 41408
- Status last verified
- Feb 2018
- First submitted
- 4 Jul 2014
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moller AB, Lonbro S, Farup J, Voss TS, Rittig N, Wang J, Hojris I, Mikkelsen UR, Jessen N. Molecular and cellular adaptations to exercise training in skeletal muscle from cancer patients treated with chemotherapy. J Cancer Res Clin Oncol. 2019 Jun;145(6):1449-1460. doi: 10.1007/s00432-019-02911-5. Epub 2019 Apr 9.
PubMed 30968255
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Resistance Training and Aerobic Training on Body Composition During Chemotherapy
- ClinicalTrials.gov ID
- NCT02192216
- Acronym / sponsor ID
- SKDM2014
- Conditions
- Neoplasms
- Keywords
- Body composition, Chemotherapy, Muscle mass, Muscle function, Exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting issues and limited personel ressources
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Department of Public Health, DenmarkUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chemotherapy can induce muscle loss in colorectal, breast and advanced renal cell carcinoma patients. The Danish nation-wide training and rehabilitation offer 'Body \& Cancer' offers intensive resistance and endurance training to all Danish cancer patients receiving chemotherapy with the aim of reducing treatment-related fatigue and physical impairments, but the potential of the training to preserve or improve muscle mass is uninvestigated.
Furthermore, the underlying biological mechanisms of treatment and/or exercise induced changes in muscle mass in cancer patients remains uninvestigated.
Thus, the primary purpose of the present study is to investigate changes in body composition during chemotherapy and after resistance and aerobic training combined with protein supplementation during ongoing chemotherapy in cancer patients. Secondly, we aim to investigate the underlying biological mechanisms of muscle mass regulation in biopsies obtained before and after a control period as well as after 10 weeks of exercise, both during chemotherapy.
We hypothesize that 10 weeks exercise will improve muscle mass and body composition in cancer patients during chemotherapy as compared to a control period during chemotherapy alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise & Chemotherapy | Experimental | Behavioral: ExerciseFollowing a control period during active chemotherapy the patients undergo ten weeks of supervised exercise comprised of resistance and aerobic training in combination with protein supplementation during ongoing chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Currently receiving curative, adjuvant, neo-adjuvant or palliative chemotherapy
- No documented bone metastases or myelomatosis
- No documented CNS affection
- WHO performance status 0-1
- No chronical thrombocytopenia or leukopenia
Key exclusion criteria (1 listed)
- Participation in systematic resistance training three months prior to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Resistance training, Aerobic exercise, Protein supplementation | Behavioural | Exercise & Chemotherapy |
Primary outcome
Changes in body composition
Time frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
Changes in lean body mass and fat mass wil be assessed using Dual Energy X-Ray Absorptiometry
5 secondary outcomes
Changes in underlying biological mechanisms associated with changes in muscle mass
Time frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
Changes in dynamic muscle strength
Time frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
Changes in aerobic performance
Time frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
Changes in cancer related fatigue and quality of life
Time frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
Changes in functional performance
Time frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
Results and safety
The study was stopped early (reason given: Recruiting issues and limited personel ressources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Derived from this study: PubMed 30968255Moller AB, Lonbro S, Farup J, Voss TS, Rittig N, Wang J, Hojris I, Mikkelsen UR, Jessen N. Molecular and cellular adaptations to exercise training in skeletal muscle from cancer patients treated with chemotherapy. J Cancer Res Clin Oncol. 2019 Jun;145(6):1449-1460. doi: 10.1007/s00432-019-02911-5. Epub 2019 Apr 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Loenbro, M.Sc., PhD principal investigator
Dept. of Public Health, Sect. for Sports Science, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Neoplasms, run by Department of Public Health, Denmark 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 10 inclusion and 1 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 1 Mar 2018. 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: Recruiting issues and limited personel ressources). 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?
Changes in body composition (time frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).). 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 NCT02192216, 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 1 Mar 2018.