Clinical trial NCT01684579: Exercising Our ABC's (African- American Breast Cancer Survivors)
Official title: Exercising Our ABC's (African- American Breast Cancer Survivors)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: Breast Cancer
African-American Women
Aerobic Exercise
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-09-13
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Recent studies have shown that some behavioral factors such as physical activity and exercise may improve quality of life and outcome in patients with breast cancer as well as decrease body fat, increase lean mass and reduce cancer-promoting hormones. None of these studies have been performed in African-American women with breast cancer. The medical field needs to understand how exercise may benefit cancer patients, particularly African Americans, and how to optimize these benefits to improve the quality of life, prognosis and survival.

Detailed description: All exercise training will take place at the Gathering Place, Beachwood OH, in the new Wellness Center that is equipped with state-of-the-art aerobic and resistance training apparati. All exercise will be performed under the supervision of the Gathering Place trained and certified staff. The patient group will perform a 20 week aerobic and resistance exercise training program to evaluate (compared to baseline) changes: in body composition (fat, lean tissue and bone mass); cytokines including insulin, leptin, adiponectin, IL-6, and TNFα; oxidative stress including urine isoprostane; cardiorespiratory fitness (VO2max); upper and lower body strength (assessed using a dynamometer); sleep (assessed using the Pittsburgh Sleep Quality Index \[PSQI\]); fatigue and quality of life (Qol) (assessed using the SF-36, FACIT instruments). Patients will be evaluated before and after a 20 week intervention and a 10 week post-intervention period. Participants also will be evaluated for motivation barriers and compliance. These feasibility parameters will provide the basis and guidance for an NCI grant application to focus on mechanisms and extend our evaluation to larger cohorts of African-American patients.

Eligibility criteria: Inclusion Criteria:

* Female patients with a histological confirmation of breast cancer.
* Age 18 years and older.
* Stage I-III. Limiting the cohort to stage I-III cancer limits mortality during the 8-month follow-up period and allows completion of follow-up procedures as well as enhances exercise participation, i.e. no painful bone metastases or danger of pathologic fracture, etc.
* Eligible patients will include African-American women only.
* Women with recently diagnosed breast cancer who are no more than 12 months after completion of initial therapies including neoadjuvant therapy, surgery, radiation and/or chemotherapy and who are not receiving or scheduled to receive further active cytotoxic therapy other than adjuvant hormonal therapy or targeted therapy. Women receiving hormonal therapy or targeted will be eligible to participate in these studies.
* Eligible patients will include those who meet the criteria for exercise safety as defined in the American Heart Association and the American College of Sports Medicine exercise pre-participation questionnaire. All Women will require clearance by cardiologist.
* Eligible patients include the ability to travel to the Gathering Place, Beachwood OH and participate in the new Wellness Center that is equipped with state-of-the-art aerobic and resistance training apparati.

Exclusion Criteria:

* Caucasian (non-African-American) and male breast cancer patients.
* Patients who are beyond 12 months after completion of initial therapies for breast cancer, or continuing to receive active therapy including neoadjuvant therapy, surgery, radiation and/or chemotherapy.
* Patients with stage IV disease, severe dementia or life-expectancy less than 6-months.
* Patients will be deemed ineligible if they do not fulfill the criteria for exercise safety as defined in the American Heart Association and the American College of Sports Medicine exercise pre-participation questionnaire or do not receive clearance from cardiologist.
* Inability to understand English as the exercise instructors may not be fluent in foreign languages and several of the instruments used to assessment have not been translated into other languages.
* Inability to travel to the Gathering Place, Beachwood OH and participate in the new Wellness Center that is equipped with state-of-the-art aerobic and resistance training apparati.(Taxi fare to and from The Gathering Place will be provided where required)
* History of connective tissue disorder that would limit exercise.
* Inability to provide informed consent.

Primary outcomes:
measure: Identify factors contributing to or limiting the success of development of the community-academic partnership.
timeFrame: 30 weeks
Secondary outcomes:
measure: Number of African-American women that participate, comply, adhere and sustain an aerobic and resistance exercise program.
timeFrame: 30 weeks
measure: Change in circulating levels of known cancer promoting cytokines, adipokines and hormones and other measurements of fitness and well-being.
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Nathan Berger, MD
role: PRINCIPAL_INVESTIGATOR
References: