Acute Exercise Intervention in Breast Cancer Survivors

NCT03779867 | Terminated

• 3 other identifiers: RG1003977NCI-2018-028318766
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how a 45-minute bout of acute exercise in women with a history of breast cancer can affect factors associated with breast cancer and help doctors learn more about how exercise can help prevent breast cancer. In an earlier part of the study, investigators looked at the effects of the same intervention in women without a history of cancer.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (12)

• Mean change in homeostatic model assessment of insulin resistance (HOMA-IR)

  Will compare the average changes in HOMA-IR from baseline to 45 minutes between the exercisers and controls.

  Baseline up to 45 minutes

• Mean change in HOMA-IR

  Will compare the average changes in HOMA-IR from baseline to 105 minutes between the exercisers and controls.

  Baseline up to 105 minutes

• Change in insulin level

  Will compare changes in insulin level from baseline to 45 minutes between the exercisers and controls.

  Baseline up to 45 minutes

• Change in insulin level

  Will compare changes in insulin level from baseline to 105 minutes between the exercisers and controls.

  Baseline up to 105 minutes

• Change in glucose level

  Will compare changes in glucose level from baseline to 45 minutes between the exercisers and controls.

  Baseline up to 45 minutes

• Change in glucose level

  Will compare changes in glucose level from baseline to 105 minutes between the exercisers and controls.

  Baseline up to 105 minutes

• Change in Vascular Endothelial Growth Factor (VEGF) level

  Will compare changes in VEGF level from baseline to 45 minutes between the exercisers and controls.

  Baseline up to 45 minutes

• Change in VEGF level

  Will compare changes in VEGF level from baseline to 105 minutes between the exercisers and controls.

  Baseline up to 105 minutes

• Change in Irisin level

  Will compare changes in Irisin level from baseline to 45 minutes between the exercisers and controls.

  Baseline up to 45 minutes

• Change in Irisin level

  Will compare changes in Irisin level from baseline to 105 minutes between the exercisers and controls.

  Baseline up to 105 minutes

• Change in Plasminogen activator inhibitor type-1 (PAI-1) level

  Will compare changes in PAI-1 level from baseline to 45 minutes between the exercisers and controls.

  Baseline up to 45 minutes

• Change in PAI-1 level

  Will compare changes in PAI-1 level from baseline to 105 minutes between the exercisers and controls.

  Baseline up to 105 minutes

Secondary Outcomes (5)

• Effects of exercise on HOMA-IR in normal-weight participants

  At 45 minutes

• Effects of exercise on HOMA-IR in overweight/obese participants

  At 45 minutes

• Change in C-reactive protein (CRP)

  Baseline up to 105 minutes

• Change in Interleukin (IL)-6

  Baseline up to 105 minutes

• Change in Monocyte chemotactic protein (MCP)-1

  Baseline up to 105 minutes

Study Arms (2)

Arm I (acute exercise)

EXPERIMENTAL

Participants undergo a moderate-intensity acute exercise bout over 45 minutes.

Behavioral: Exercise Intervention; Other: Biomarker Analysis; Other: Questionnaire Administration

Arm II (rest)

ACTIVE COMPARATOR

Participants rest by sitting for 45 minutes.

Other: Resting; Other: Biomarker Analysis; Other: Questionnaire Administration

Interventions

Exercise Intervention BEHAVIORAL

Undergo acute exercise

Arm I (acute exercise)

Resting OTHER

Seated resting

Also known as: Rest

Arm II (rest)

Biomarker Analysis OTHER

Correlative studies

Arm I (acute exercise); Arm II (rest)

Questionnaire Administration OTHER

Ancillary studies

Arm I (acute exercise); Arm II (rest)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• History of Stage 0-IIIc breast cancer, diagnosed within the last 5 years
• Completed primary treatment at least 6 months ago
• Able to attend 2 clinic visits at the Fred Hutch Prevention Center for approximately 2.5 hours at a time
• Aged 36-75 years. Younger women will be excluded because a sizable proportion may remain premenopausal and will resume menstruation within 2 years of chemotherapy completion.
• Postmenopausal (no menstrual periods in the previous 12 months either naturally, or as a consequence of treatment)
• All race and ethnic groups are eligible for the study
• Able to perform all study requirements, including attendance at clinic visits and capable of responding to questionnaires and clinic and exercise facility instructions in English
• Willing to consent to release of medical records for their breast cancer diagnosis and treatment
• If a patient has received a cardiotoxic therapy (e.g., Adriamycin, Herceptin), clearance of their oncologist to participated in this study will be required.
• Resident in greater Seattle metropolitan area (King County), Pierce or Snohomish Counties
• Healthy
• Able to perform all study requirements, including attendance at clinic visits and capable of responding to questionnaires and clinic and exercise facility instructions in English
• Willing to be randomized
• Capable of providing informed consent

You may not qualify if:

• Family history of breast cancer
• If known, BRCA 1/2 mutation carrier
• If known, Li-Fraumeni Syndrome
• Personal history of cancer other than breast: exceptions are non-melanoma skin cancer and cervical neoplasia (CIN)
• Serious health conditions including diabetes, renal disease (e.g., chronic kidney disease), liver disease (e.g., cirrhosis, chronic liver failure), chronic lung disease (COPD, moderate or severe persistent asthma), auto-immune disease requiring oral or inhaled medication, congestive heart failure, or other condition likely to interfere with ability to exercise at moderate levels and undergo biosampling, or likely to interfere with study outcomes.
• Fasting glucose fingerstick \>126 mg/dL
• Taking any medications to treat high blood sugar such as metformin
• Contraindications for exercise testing (29) including: recent (within 6 months) cardiac event (MI, pulmonary edema, myocarditis, pericarditis), unstable angina, uncontrolled arrhythmia, third degree heart block, left bundle branch block, acute congestive failure, recent (within 6 months) pulmonary/systemic embolus, severe electrolyte abnormality, deep vein thrombosis, uncontrolled hypertension (systolic \> 200, diastolic \> 100), orthostatic hypotension, moderate/severe aortic stenosis, uncontrolled arrhythmia, uncontrolled congestive heart failure, history of cardiac arrest or stroke, or as assessed by the physician assistant during the physical exam.
• History of clotting disorders
• Unable or unwilling to stop aspirin or NSAIDs for 48 hours before and after the procedure
• Allergy to anesthetics or local anesthetics
• Long term use of warfarin or similar medications
• Use of medications that could affect exercise ability, blood biomarkers, or muscle biomarkers, including weight loss medications, statins, oral beta-blockers, performance-enhancing drugs, metformin or other diabetic drug, and oral corticosteroids.
• Use of any sex hormones (estrogen, progesterone, testosterone or other androgens, for the previous 3 months) of any type including oral, creams, vaginal creams or inserts, patches, implants). Participants will be allowed to be on maintenance anti-estrogen therapy - e.g., tamoxifen, aromatase inhibitors
• Consumption of (on average) more than 2 alcoholic drinks per day

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Duggan C, de Dieu Tapsoba J, Warner J, Dash A, Wang CY, McTiernan A. Effects of acute exercise on inflammatory and metabolic biomarkers in women: a randomized controlled trial. NPJ Breast Cancer. 2025 Nov 7;11(1):122. doi: 10.1038/s41523-025-00834-8.

  PMID: 41203676 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

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

Study Officials

• Anne McTiernan

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study personnel other than the statisticians and exercise physiologist will be masked to participant study arm
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: March 25, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)