- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01684579
Exercising Our ABC's (African- American Breast Cancer Survivors)
March 18, 2013 updated by: Case Comprehensive Cancer Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
-
Cleveland, Ohio, United States, 44106
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise and psychosocial counseling
Patients will participate in a psychosocial counseling session, 1 day/week for 20 weeks.
Patients will be invited to participate in a progressive aerobic and resistance exercise program designed to achieve moderate and then vigorous levels of exercise, 5 days/week for 20 weeks.
|
Resistance exercise will be performed 2 days per week for 18 weeks.
The resistance training protocol will follow the Resistance Training Strategies for Individuals With Cancer (RTSFIC).
The goals will be to keep intensity levels low at the outset (having lighter weights and more reps) and progress slowly and safely.
Training prescriptions will be modified based on the training level of the patients and their progress.
A 20-week aerobic walking exercise program will be developed for each participant based on results of initial exercise testing and prescribed to be done 5 or more days per week designed to progress from moderate exercise intensity, (50-70% maximum heart rate), to vigorous exercise intensity (75-85% maximum heart rate).
Maximum heart rate (HR max) will be determined as the peak heart rate achieved during initial cardiopulmonary exercise screening.
Heart rate during exercise will be monitored by participants using wrist monitors, already available through TREC Program.
Patient progress will also be evaluated using a six minute walk test (6MWT), which will be conducted at TGP at baseline, 6, 12 and 18 weeks and, after completion of the intervention.
The psychosocial component of the 20-week exercise program includes a 1 ½ hour support group offered prior to one of the weekly exercise classes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identify factors contributing to or limiting the success of development of the community-academic partnership.
Time Frame: 30 weeks
|
The primary endpoint is to determine if a successful partnership can be established between a community program, The Gathering Place, committed to providing support services to all community individuals with all types of cancer and academic researchers and clinicians at CWRU, Cleveland Clinic, UHCMC focused on modifying factors associated with energy balance to improve physical and psychological quality of life in cancer patients and provide the basis for future studies and programs to improve prognosis and survival.
|
30 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of African-American women that participate, comply, adhere and sustain an aerobic and resistance exercise program.
Time Frame: 30 weeks
|
A secondary endpoint is to determine if African-American women at the completion of initial therapy for stage I-III breast cancer can be engaged to participate, comply, adhere and sustain an aerobic and resistance exercise program accompanied by psychosocial counseling to improve physical and psychological quality of life.
|
30 weeks
|
Change in circulating levels of known cancer promoting cytokines, adipokines and hormones and other measurements of fitness and well-being.
Time Frame: 30 weeks
|
Ascertain if a graded program to increase aerobic and resistance exercise activities along with psychosocial counseling can be used in African-American women at the completion of initial therapy for breast cancer to improve circulating levels of known cancer promoting cytokines, adipokines and hormones and other measurements of fitness and well-being.
|
30 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nathan Berger, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
September 11, 2012
First Submitted That Met QC Criteria
September 11, 2012
First Posted (Estimate)
September 13, 2012
Study Record Updates
Last Update Posted (Estimate)
March 20, 2013
Last Update Submitted That Met QC Criteria
March 18, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE2111
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Clinical Trials on Resistance Exercise
-
Universidade Federal de PernambucoUnknownChikungunya FeverBrazil
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)TerminatedChildhood ObesityUnited States
-
Instituto de Cardiologia do Rio Grande do SulCompletedHypertension | Healthy
-
Iowa State UniversityCompletedCardiovascular Risk Factor
-
University of AlbertaDexCom, Inc.CompletedType 1 DiabetesCanada
-
VA Office of Research and DevelopmentRecruiting
-
Mekelle UniversityCompleted
-
University of Central FloridaCompletedHealthyUnited States
-
National Taiwan Normal UniversityCompletedExecutive FunctionTaiwan
-
Bangor UniversityBetsi Cadwaladr University Health BoardCompletedChronic Kidney DiseaseUnited Kingdom