OptiTrain - Optimal Training Women With Breast Cancer

NCT02522260 | Completed DMC

• 1 other identifier: YWengstrom
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This study on women with breast cancer during and after chemo- and hormonal therapy compares the effect of different physical training programs on physical and mental well-being and systemic inflammation mechanisms in blood. In a sub-group of participants, mitochondrial biogenesis and function and other molecular processes in skeletal muscle biopsies are studied. The women will be randomly allocated into three different intervention arms, a control arm with usual care and two different training arms. All participants will respond to questionnaires and have blood samples and taken and for a subgroup muscle biopsies before and after the exercise intervention. Participants will be supported to uphold exercise through collaboration with Friskis \& Svettis and followed for 5 years. Some of the women will also be asked to participate in an in depth interview about the experiences of exercise during ongoing treatment. This study will contribute to increased knowledge about the type, intensity and frequency of training that patients with breast cancer benefit most from with regards to impact on physical and mental wellbeing. This knowledge is of great importance since experience shows that patients and relatives often seek information about rehabilitation, self-care and physical activity. The study will also contribute to the improvement of the patients´ quality of life, ability to return to work, and reduce social costs, but above all, increase the possibility for development and implementation of evidence-based rehabilitation of women with breast cancer during and after active treatment.

Conditions

Well Being

Keywords

Breast cancer, chemotherapy, symptoms, optimal training

Outcome Measures

Primary Outcomes (1)

• Cancer related fatigue

  Piper fatigue scale

  Change from baseline to 16 weeks, 1 year, 2 years, and 5 years post baseline

Secondary Outcomes (22)

• Health Related Quality of Life

  Change from baseline to 16 weeks, 1 year, 2 years, and 5 years post baseline

• Symptoms

  Change from baseline to 16 weeks, 1 year, 2 years, and 5 years post baseline

• Pain sensitivity

  Change from baseline to 16 weeks, 2 years and 5 years post baseline

• Aerobic fitness

  Change from baseline to 16 weeks, 1 year, 2 years, and 5 years post baseline

• Muscle strength

  Change from baseline to 16 weeks, 1 year, 2 years, and 5 years post baseline

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Intervention Strength/aerobic exercise, weights, bike or treadmill

Other: Resistance and aerobic training

Group 2

ACTIVE COMPARATOR

Intervention Aerobic exercise, bike or treadmill

Other: Aerobic training

Group 3

ACTIVE COMPARATOR

Standard supportive care

Other: Standard supportive care

Interventions

Resistance and aerobic training OTHER

Group 1) includes strength exercise of the large muscle groups (2-3 sets, 8-12 repetitions on an intensity of 80 % of 1-RM) and 3x3 min high intensity aerobic exercise (16-18 on Borg scale) on an exercise bike or treadmill twice a week for 16 weeks

Group 1

Aerobic training OTHER

Group 2) includes aerobic exercise on an exercise bike or treadmill, 20 min moderate intensity (13-15 on Borg scale), and 3x3 min high intensity (16-18 on Borg scale) twice a week during 16 weeks

Group 2

Standard supportive care OTHER

Standard supportive care

Group 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients up to 70 years with breast cancer Stage I-IIIa before the start of chemotherapy.

You may not qualify if:

• patients with advanced disease, patients where physical activity is considered contraindicated because of medical reasons such as heart or lung disease, brain or bone metastases, cognitive dysfunction, and patients who do not speak or understand the Swedish language.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 114, Sweden

Location

Related Publications (5)

• Ansund J, Mijwel S, Bolam KA, Altena R, Wengstrom Y, Rullman E, Rundqvist H. High intensity exercise during breast cancer chemotherapy - effects on long-term myocardial damage and physical capacity - data from the OptiTrain RCT. Cardiooncology. 2021 Feb 15;7(1):7. doi: 10.1186/s40959-021-00091-1.

  PMID: 33588948 DERIVED

• Hiensch AE, Mijwel S, Bargiela D, Wengstrom Y, May AM, Rundqvist H. Inflammation Mediates Exercise Effects on Fatigue in Patients with Breast Cancer. Med Sci Sports Exerc. 2021 Mar 1;53(3):496-504. doi: 10.1249/MSS.0000000000002490.

  PMID: 32910094 DERIVED

• Bolam KA, Mijwel S, Rundqvist H, Wengstrom Y. Two-year follow-up of the OptiTrain randomised controlled exercise trial. Breast Cancer Res Treat. 2019 Jun;175(3):637-648. doi: 10.1007/s10549-019-05204-0. Epub 2019 Mar 26.

  PMID: 30915663 DERIVED

• Mijwel S, Backman M, Bolam KA, Jervaeus A, Sundberg CJ, Margolin S, Browall M, Rundqvist H, Wengstrom Y. Adding high-intensity interval training to conventional training modalities: optimizing health-related outcomes during chemotherapy for breast cancer: the OptiTrain randomized controlled trial. Breast Cancer Res Treat. 2018 Feb;168(1):79-93. doi: 10.1007/s10549-017-4571-3. Epub 2017 Nov 14.

  PMID: 29139007 DERIVED

• Wengstrom Y, Bolam KA, Mijwel S, Sundberg CJ, Backman M, Browall M, Norrbom J, Rundqvist H. Optitrain: a randomised controlled exercise trial for women with breast cancer undergoing chemotherapy. BMC Cancer. 2017 Feb 6;17(1):100. doi: 10.1186/s12885-017-3079-x.

  PMID: 28166765 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yvonne Wengstrom, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OCN, PhD, Professor of Nursing

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: August 13, 2015
• Study Start: March 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: June 1, 2021
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

SE (1)