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

NCT02235051 | Completed DMC

• 2 other identifiers: 14135NCI-2014-01876
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Change in 60 minutes mean olive tail moments measured by the Comet assay

  Comet assay data will be analyzed according to methods by Wiklund et al. Log-transformed, mean Olive tail moments, assessing DNA damage, will be calculated and compared using a paired t-test. For the ex vivo analyses using a challenge assay, Log-transformed, mean Olive tail moments will be calculated before and after the introduction of the damaging agent at 0, 1 and 6 hours. Differences between the changes will be analyzed using the paired t-test. Multivariate analysis of variance (MANOVA) for repeated measure will be performed and linear regression models will be fitted.

  Baseline to 16 weeks

• Change in level of interleukin-6 (IL-6) cytokine measured by the 13 Plex-Immunology Multiplex Assay by EMD Millipore

  Paired t-tests will be used to compare pre-exercise cytokine concentrations in order to test whether the 16-week Curves exercise intervention decreased markers of inflammation. As secondary analysis linear regression models will be fitted.

  Baseline to 16 weeks

• Change in telomerase activity using the Trypan blue method and ImagedQuant

  Paired t-tests will be used to compare pre-exercise telomerase activity in order to test the 16-week Curves exercise intervention. As a second analysis regression models will be fitted. Potential confounding factors that may contribute to differences within the two groups of women (e.g. BMI, exercise intensity, etc.) will be investigated and included as appropriate. The impact of exercise intensity via CurvesSmart card will also be examined.

  Baseline to up to 16 weeks

Secondary Outcomes (12)

• Change in the number of gamma-H2A histone, member X (H2AX) foci measured by the gamma-H2AX assay

  Baseline to 16 weeks

• Change in C-reactive protein (CRP) and levels of cytokines measured by the 13 Plex-Immunology Multiplex Assay by EMD Millipore

  Baseline to 16 weeks

• Adherence to the study protocol

  16 weeks

• Changes in weight

  Baseline to 16 weeks

• Changes in BMI

  Baseline to 16 weeks

Study Arms (2)

Arm I (exercise intervention)

EXPERIMENTAL

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.

Behavioral: exercise intervention; Other: laboratory biomarker analysis; Other: questionnaire administration; Other: quality-of-life assessment

Arm II (no formal exercise intervention)

NO INTERVENTION

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

Interventions

exercise intervention BEHAVIORAL

Undergo Curves exercise program

Arm I (exercise intervention)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (exercise intervention)

questionnaire administration OTHER

Ancillary studies

Arm I (exercise intervention)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Arm I (exercise intervention)

Eligibility Criteria

• Age: 56 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jessica Clague DeHart

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 9, 2014
• Study Start: September 7, 2014
• Primary Completion: December 19, 2016
• Study Completion: June 3, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

US (1)