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OptiTrain - Optimal Training Women With Breast Cancer (OptiTrain)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02522260
Recruitment Status : Active, not recruiting
First Posted : August 13, 2015
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Yvonne Wengstrom, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Well Being Other: Resistance and aerobic training Other: Aerobic training Other: Standard supportive care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: OptiTrain - Optimal Training for Women With Breast Cancer During Chemotherapy Treatment
Actual Study Start Date : March 2013
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Group 1
Intervention Strength/aerobic exercise, weights, bike or treadmill
Other: Resistance and aerobic training
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

Active Comparator: Group 2
Intervention Aerobic exercise, bike or treadmill
Other: Aerobic training
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

Active Comparator: Group 3
Standard supportive care
Other: Standard supportive care
Standard supportive care




Primary Outcome Measures :
  1. Cancer related fatigue [ Time Frame: Change from baseline to 16 weeks ]
    Piper fatigue scale


Secondary Outcome Measures :
  1. Health Related Quality of Life [ Time Frame: Change from baseline to 16 weeks ]
    EORTC-QLQ-C30

  2. Symptoms [ Time Frame: Change from baseline to 16 weeks ]
    Memorial Symptom Assessment Scale

  3. Pain sensitivity [ Time Frame: Change from baseline to 16 weeks ]
    Algometer

  4. Aerobic fitness [ Time Frame: Change from baseline to 16 weeks ]
    Submaximal cycling test

  5. Muscle strength [ Time Frame: Change from baseline to 16 weeks ]
    Upper and lower limb muscle strength

  6. Body mass [ Time Frame: Change from baseline to 16 weeks ]
    Scale

  7. Inflammation parameters [ Time Frame: Change from baseline to 16 weeks ]
    Blood

  8. Muscle cross sectional area [ Time Frame: Change from baseline to 16 weeks ]
    Muscle biopsy

  9. Mitochondrial function, gene activity [ Time Frame: Change from baseline to 16 weeks ]
    Muscle biopsy

  10. Sense of coherence [ Time Frame: Baseline ]
    Sense of coherence questionnaire

  11. Chemotherapy completion [ Time Frame: Baseline to 16 weeks ]
    Relative dose intensity extracted from medical records

  12. Hospitalization [ Time Frame: Baseline to 16 weeks ]
    Hospitalizion rates during chemotherapy extracted from medical records

  13. Blood concentrations [ Time Frame: Baseline to 16 weeks ]
    Neutrophil, lymphocyte, hemoglobin, and platelet concentrations extracted from medical records



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522260


Locations
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Sweden
Karolinska University Hospital
Stockholm, Sweden, 114
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Yvonne Wengstrom, Professor Karolinska Institutet, Stockholm, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yvonne Wengstrom, OCN, PhD, Professor of Nursing, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02522260    
Other Study ID Numbers: YWengstrom
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Keywords provided by Yvonne Wengstrom, Karolinska Institutet:
Breast cancer, chemotherapy, symptoms, optimal training
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases