|
Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer Clinical research trials and Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer. Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer  Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer
Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer
For Condition: stage 2 breast cancer,stage 1 breast cancer,Quality of Life,Depression,stage 3A breast cancer,weight changes
Status: Recruiting
Sponsor(s): Comprehensive Cancer Center of Wake Forest University , National Cancer Institute (NCI)
Synopsis: RATIONALE: A home-based exercise and/or diet program may improve the quality of life of breast cancer patients by preventing an increase in body fat and weight and a loss of lean body tissue. PURPOSE: Randomizedphase II trial to compare the effectiveness of three home-based diet and/or exercise programs in preventing weight gain and loss of muscle tissue in women who are receiving chemotherapy for stage I, stage II, or stage IIIA breast cancer.
Details: OBJECTIVES: - Compare the efficacy of exercise alone or combined with a modified diet as home-based interventions to prevent increases in body fat during adjuvant chemotherapy in women with stage I, II, or IIIA breast cancer. - Compare the efficacy of these regimens, in terms of reducing gains in adipose tissue, reducing losses in absolute amounts of lean body tissue, reducing gains in weight, influencing levels of biomarkers associated with the risk of breast cancer and/or other comorbid conditions, improving self-efficacy for exercise behaviors, reducing depression, and improving quality of life in these patients. - Compare the adherence rates to these regimens in these patients. - Determine the associations between study condition and adherence and change in endpoints in patients treated with these regimens. - Determine the feasibility of conducting home-based exercise and diet studies using the infrastructure of the cooperative group. OUTLINE: This is a pilot, randomized, multicenter study. Patients are stratified according to body mass index (no more than 25 kg/m^2 vs more than 25 kg/m^2), race (white vs non-white), and prior exercise history (vigorous exercise of at least 30 minutes, 3 times a week prior to diagnosis) (yes vs no). Patients are randomized to 1 of 3 treatment arms. - Arm I (calcium-rich diet): Patients receive materials and counseling to promote a diet that contains ample amounts of calcium (1,200-2,500 mg/day). - Arm II (calcium-rich diet and exercise): Patients receive materials and counseling as in arm I and instruction and materials to promote strength training and endurance exercises. - Arm III (calcium-rich, high fruit and vegetable, low-fat diet and exercise): Patients receive materials and counseling as in arm II and materials and counseling to consume at least 5 servings of vegetables and fruit per day and limit fat intake to less than 20% of total calories. In all arms, patients continue regimens for 6 months. Measurements of body composition, weight, waist circumference, serum levels of insulin, insulin-like growth factor, sex hormone-binding globulin, and total cholesterol are obtained at baseline and 6 months. Quality of life, depression, diet composition, and physical activity are assessed at baseline and at 3 and 6 months. Patients are followed at 1 month. PROJECTED ACCRUAL: A total of 90 patients (30 per treatment arm) will be accrued for this study within 16 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer - Stage I, II, or IIIA - Scheduled to receive adjuvant chemotherapy OR received 1 prior course of chemotherapy - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal Status - Premenopausal, defined as at least 1 of the following: - Less than 4 months since last menstrual period at diagnosis - Follicle-stimulating hormone level in the premenopausal range Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - No calcium-based kidney stones Cardiovascular - No angina within the past 6 months - No myocardial infarction within the past 6 months - No abnormal MUGA and/or stress test Other - Not pregnant or nursing - Access to a telephone - Able to read and speak English - No other prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer - No history of hyperthyroidism or hypothyroidism - No paralysis - No osteoarthritis with uncontrolled joint pain that would preclude exercise - No diverticulitis - No serious medical or psychiatric illness that would preclude giving informed consent or completing study therapy or quality of life questionnaires - No medical condition that would interfere with body composition assessment - No medical condition for which unsupervised exercise is contraindicated - No medical condition for which a high vegetable and fruit diet or a calcium-rich diet is contraindicated PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - No prior bilateral oophorectomy - No prior amputation - No concurrent transverse rectus abdominis myocutaneous surgery - No concurrent surgery Other - No concurrent blood-thinners (e.g., coumadin or warfarin)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WendyDemark-Wahnefried, , Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Wendy Demark-Wahnefried 919-681-3261
Cancer Centers of the Carolinas - Eastside *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-987-7000
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1030
United States
Recruiting Edward Shaw 336-716-4647
Southeastern Medical Oncology Center *Recruiting*
Goldsboro, North Carolina, 27534
United States
Recruiting James Atkins 919-580-0000
Additional Information:
Study ID Numbers: CDR0000322831; CCCWFU-97301,CCCWFU-BG02-196,CCCWFU-00-29(A)
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068458
Other Stage 1 Breast Cancer Studies:
1. Treatment of Depression in Patients with PTSD
2. Genetics of Fibromyalgia
3. Depression In Juvenile Diabetics
4. Middle School to High School Transition Project
5. Effectiveness of Team Treatment of Depression in Primary Care
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer
|
|
|
|
|
|
|
|
