Clinical trial NCT02235051: Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors
Official title: Deciphering the Breast Cancer Exercise Paradox: The Role of DNA Repair and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-09-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 56
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in 60 minutes mean olive tail moments measured by the Comet assay
timeFrame: Baseline to 16 weeks
measure: Change in level of interleukin-6 (IL-6) cytokine measured by the 13 Plex-Immunology Multiplex Assay by EMD Millipore
timeFrame: Baseline to 16 weeks
measure: Change in telomerase activity using the Trypan blue method and ImagedQuant
timeFrame: Baseline to up to 16 weeks
Secondary outcomes:
measure: Change in the number of gamma-H2A histone, member X (H2AX) foci measured by the gamma-H2AX assay
timeFrame: Baseline to 16 weeks
measure: Change in C-reactive protein (CRP) and levels of cytokines measured by the 13 Plex-Immunology Multiplex Assay by EMD Millipore
timeFrame: Baseline to 16 weeks
measure: Adherence to the study protocol
timeFrame: 16 weeks
measure: Changes in weight
timeFrame: Baseline to 16 weeks
measure: Changes in BMI
timeFrame: Baseline to 16 weeks
measure: Changes in percent body fat
timeFrame: Baseline to 16 weeks
measure: Changes in cardiopulmonary function
timeFrame: Baseline to 16 weeks
measure: Changes in muscle strength
timeFrame: Baseline to 16 weeks
measure: Changes in functional capacity
timeFrame: Baseline to 16 weeks
measure: Changes in quality of life scores
timeFrame: Baseline to 16 weeks
measure: Incidence of exercise-attributed injury
timeFrame: 16 weeks
measure: Change in telomere length as measured by quantitative polymerase chain reaction
timeFrame: Baseline up to 16 weeks
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Jessica Clague DeHart
role: PRINCIPAL_INVESTIGATOR
References: