Clinical trial NCT02192216: The Effect of Resistance Training and Aerobic Training on Body Composition During Chemotherapy
Official title: The Effect of Resistance Training and Aerobic Training on Body Composition During Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neoplasms
Keywords: Body composition
Chemotherapy
Muscle mass
Muscle function
Exercise
Lead sponsor: Department of Public Health, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2014-07-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in body composition
timeFrame: 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:
measure: Changes in underlying biological mechanisms associated with changes in muscle mass
timeFrame: 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).
measure: Changes in dynamic muscle strength
timeFrame: 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).
measure: Changes in aerobic performance
timeFrame: 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).
measure: Changes in cancer related fatigue and quality of life
timeFrame: 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).
measure: Changes in functional performance
timeFrame: 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).
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Dept of Oncology, Aarhus University Hospital
Study officials:
affiliation: Dept. of Public Health, Sect. for Sports Science, Aarhus University
name: Simon Loenbro, M.Sc., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.