Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068458
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2003-09-10
Brief Title:
Survival TRaining for ENhancing Total Health STRENGTH
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase II Randomized Study to Assess the Feasibility of Distance Medicine Based Exercise and Dietary Approaches to Prevent Body Composition Change Occurring During Adjuvant Chemotherapy for Early Stage Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE A home-based exercise andor 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 This randomized phase II trial is studying the effectiveness of three home-based diet andor 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
PURPOSE This randomized phase II trial is studying the effectiveness of three home-based diet andor 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
Detailed Description:
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 andor 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 kgm2 vs more than 25 kgm2 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 1200-2500 mgday
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
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 andor 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 kgm2 vs more than 25 kgm2 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 1200-2500 mgday
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA081851 | NIH | None | httpsreporternihgovquickSearchU10CA081851 |