Acute Exercise Intervention in Breast Cancer Survivors

Not Applicable

Terminated

• Conditions: Breast Carcinoma
• Interventions: Other: Resting; Behavioral: Exercise Intervention; Other: Biomarker Analysis; Other: Questionnaire Administration

• Registration Number: NCT03779867
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

Detailed Description

OUTLINE: Participants are randomized to 1 of 2 arms.

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

ARM II: Participants rest by sitting for 45 minutes.

EXTENSION: After completion of initial study recruitment and data collection, an extension was approved in 2023.

EXTENSION OUTLINE: Participants are randomized to 1 of 2 arms.

EXTENSION ARM I: Participants exercise on a stationary bike for 45 minutes.

EXTENSION ARM II: Participants rest by sitting for 45 minutes.

Study Timeline

• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-03-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (acute exercise)	Questionnaire Administration	Participants undergo a moderate-intensity acute exercise bout over 45 minutes.
Arm II (rest)	Resting	Participants rest by sitting for 45 minutes.
Arm II (rest)	Biomarker Analysis	Participants rest by sitting for 45 minutes.
Arm I (acute exercise)	Exercise Intervention	Participants undergo a moderate-intensity acute exercise bout over 45 minutes.
Arm I (acute exercise)	Biomarker Analysis	Participants undergo a moderate-intensity acute exercise bout over 45 minutes.
Arm II (rest)	Questionnaire Administration	Participants rest by sitting for 45 minutes.

Primary Outcome Measures

Name	Time	Method
Change in Plasminogen activator inhibitor type-1 (PAI-1) level	Baseline up to 45 minutes	Will compare changes in PAI-1 level from baseline to 45 minutes between the exercisers and controls.
Change in PAI-1 level	Baseline up to 105 minutes	Will compare changes in PAI-1 level from baseline to 105 minutes between the exercisers and controls.
Change in Vascular Endothelial Growth Factor (VEGF) level	Baseline up to 45 minutes	Will compare changes in VEGF level from baseline to 45 minutes between the exercisers and controls.
Mean change in homeostatic model assessment of insulin resistance (HOMA-IR)	Baseline up to 45 minutes	Will compare the average changes in HOMA-IR from baseline to 45 minutes between the exercisers and controls.
Mean change in HOMA-IR	Baseline up to 105 minutes	Will compare the average changes in HOMA-IR from baseline to 105 minutes between the exercisers and controls.
Change in insulin level	Baseline up to 105 minutes	Will compare changes in insulin level from baseline to 105 minutes between the exercisers and controls.
Change in glucose level	Baseline up to 105 minutes	Will compare changes in glucose level from baseline to 105 minutes between the exercisers and controls.
Change in VEGF level	Baseline up to 105 minutes	Will compare changes in VEGF level from baseline to 105 minutes between the exercisers and controls.
Change in Irisin level	Baseline up to 105 minutes	Will compare changes in Irisin level from baseline to 105 minutes between the exercisers and controls.

Secondary Outcome Measures

Name	Time	Method
Effects of exercise on HOMA-IR in normal-weight participants	At 45 minutes	Will use the generalized estimating equations (GEE) model including the potential effect modification of weight category (normal weight versus \[vs\] overweight/obese) to compare the 45-minute exercise session on HOMA-IR in normal-weight versus overweight/obese women.
Effects of exercise on HOMA-IR in overweight/obese participants	At 45 minutes	Will use the GEE model including the potential effect modification of weight category (normal weight versus \[vs.\] overweight/obese) to compare the 45-minute exercise session on HOMA-IR in normal-weight versus overweight/obese women.
Change in C-reactive protein (CRP)	Baseline up to 105 minutes	Will compare changes in CRP level from baseline to 105 minutes between the exercisers and controls.
Change in Monocyte chemotactic protein (MCP)-1	Baseline up to 105 minutes	Will compare changes in MCP-1 level from baseline to 105 minutes between the exercisers and controls.
Change in Interleukin (IL)-6	Baseline up to 105 minutes	Will compare changes in IL-6 level from baseline to 105 minutes between the exercisers and controls.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States