The Effect of Resistance Training and Aerobic Training on Body Composition During Chemotherapy

NCT ID: NCT02192216

Last Updated: 2018-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise & Chemotherapy

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Interventions

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Exercise

Intervention Type BEHAVIORAL

Other Intervention Names

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Resistance training Aerobic exercise Protein supplementation

Eligibility Criteria

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Inclusion Criteria

* 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
* No serious symptoms of heart disease
* No dementia or mental illness preventing participation
* Signed written concent
* Age above 18 years

Exclusion Criteria

* Participation in systematic resistance training three months prior to inclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Department of Public Health, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Simon Lønbro

M.Sc., PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon Loenbro, M.Sc., PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Public Health, Sect. for Sports Science, Aarhus University

Locations

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Dept of Oncology, Aarhus University Hospital

Aarhus C, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 30968255 (View on PubMed)

Other Identifiers

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41408

Identifier Type: OTHER

Identifier Source: secondary_id

SKDM2014

Identifier Type: -

Identifier Source: org_study_id

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