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

NCT02192216 | Terminated DMC

• 2 other identifiers: SKDM201441408
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Keywords

Body composition; Chemotherapy; Muscle mass; Muscle function; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in underlying biological mechanisms associated with changes in muscle mass

  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

  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

  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

  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

  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).

Study Arms (1)

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.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Also known as: Resistance training, Aerobic exercise, Protein supplementation

Exercise & Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Department of Public Health, Denmark: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Dept of Oncology, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30968255 DERIVED

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Simon Loenbro, M.Sc., PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc., PhD.

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 16, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2016
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

DK (1)