Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors

NCT ID: NCT02235051

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-07
• Study Completion Date: 2022-06-03

Brief Summary

This randomized pilot trial studies how well an exercise intervention works in preventing breast cancer from coming back in postmenopausal breast cancer survivors. Regular exercise may be able to train the body to repair deoxyribonucleic acid (DNA) more efficiently and to respond to inflammation more proficiently, helping to prevent primary and recurrent breast cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To test the hypothesis that regular exercise increases DNA repair capacity.

II. To test the hypothesis that regular exercise reduces inflammatory response.

III. To test the hypothesis that regular exercise modulates telomerase activity.

SECONDARY OBJECTIVES:

I. To assess adherence to the study protocol.

II. To examine differences in body composition before and after the exercise intervention.

III. To examine differences in fitness before and after the exercise intervention.

IV. To test the hypothesis that regular exercise increases quality of life in breast cancer survivors.

V. To examine the safety of the exercise intervention.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients participate in a supervised Curves exercise program three days a week for 16 weeks. The circuit-style workout consists of 14 exercises constructed with pneumatic or hydraulic resistance that target opposing muscle groups in a concentric-only fashion. Each session at a Curves facility will include two complete circuits which correspond to exercising for approximately 30 minutes followed by a standardized stretching routine.

ARM II: Patients do not participate in a formal exercise program for 16 weeks. Patients are then offered the Curves exercise intervention.

Conditions

Cancer Survivor; Estrogen Receptor-positive Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Postmenopausal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Arm I (exercise intervention)

Patients participate in a supervised Curves exercise program three days a week for 16 weeks. The circuit-style workout consists of 14 exercises constructed with pneumatic or hydraulic resistance that target opposing muscle groups in a concentric-only fashion. Each session at Curves will include two complete circuits which correspond to exercising for approximately 30 minutes followed by a standardized stretching routine.

Group Type: EXPERIMENTAL

exercise intervention

Intervention Type: BEHAVIORAL

Undergo Curves exercise program

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

questionnaire administration

Intervention Type: OTHER

Ancillary studies

quality-of-life assessment

Intervention Type: OTHER

Ancillary studies

Arm II (no formal exercise intervention)

Patients do not participate in a formal exercise program for 16 weeks. Patients are then offered the Curves exercise intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

exercise intervention

Undergo Curves exercise program

Intervention Type: BEHAVIORAL

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

questionnaire administration

Ancillary studies

Intervention Type: OTHER

quality-of-life assessment

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

quality of life assessment

Eligibility Criteria

Inclusion Criteria

• The study will be conducted in women who have been diagnosed with a first primary invasive estrogen receptor (ER) positive (+) breast cancer (stages I-IIIa) who are within the first 3 years post-treatment
• The study will be conducted in postmenopausal women
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
• Postmenopausal, defined as meeting any of the following criteria:

• Periods stopped more than 6 months ago
• Bilateral oophorectomy
• Not already classified as pre- or peri-menopausal
• Started using hormone therapy for menopausal symptoms before periods stopped, and/or
• Hysterectomy before age 56 years but aged 56 years or more at baseline
• Any body mass index (BMI)
• Sedentary (have not participated in a regular exercise program in the past 12 months)
• Nonsmokers (not smoking during previous 12 months)
• Willing and able to travel to the exercise facility
• Diagnosed with a first primary invasive ER+ breast cancer (stages I-IIIa)
• Have undergone a lumpectomy or mastectomy
• Have completed adjuvant chemotherapy and/or radiation within the past 3 years prior to study enrollment (when cytokine levels are predicted to be high) and able to initiate an exercise program
• May use adjuvant endocrine therapy if use will be continued for duration of study period
• All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

• History of chronic disease including diabetes, uncontrolled hypertension or thyroid disease
• Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity
• Regular, necessary use of nonsteroidal anti-inflammatory drugs (NSAIDs) (will be asked to stop use during study period)
• Currently taking postmenopausal hormone replacement therapy
• Stage IV or distant metastatic disease
• Planned reconstructive surgery with flap repair during study period
• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

• Minimum Eligible Age: 56 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Clague DeHart

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

Countries

United States

Other Identifiers

NCI-2014-01876

Identifier Type: REGISTRY

Identifier Source: secondary_id

14135

Identifier Type: OTHER

Identifier Source: secondary_id

14135

Identifier Type: -

Identifier Source: org_study_id