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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02192216
• Other study ID #: SKDM2014
• Secondary ID: 41408
• Status: Terminated
• Phase: N/A
• First received: July 4, 2014
• Last updated: February 28, 2018
• Start date: February 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2018
• Source: Department of Public Health, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: December 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Behavioral:
• Exercise

Locations

Country	Name	City	State
Denmark	Dept of Oncology, Aarhus University Hospital	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
Department of Public Health, Denmark	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body composition	Changes in lean body mass and fat mass wil be assessed using Dual Energy X-Ray Absorptiometry	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	Changes in underlying biological mechanisms associated with changes in muscle mass	Analyzed from muscle biopsies from m. vastus lateralis and venous blood samples	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	Changes in dynamic muscle strength	Changes in muscle strength will be assessed using 1 repetition maximum (kg) tests using conventional training equipment.	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	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.	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	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	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	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).	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).