Breast Cancer Clinical Trial
Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors
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.
Full 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.
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
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There is 1 Location for this study
Duarte California, 91010, United States
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