Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509626
Status:
COMPLETED
Last Update Posted:
2010-02-12
First Post:
2007-07-30
Brief Title:
Physical Activity or Usual Care in Preventing Weight Gain in Women With Stage I or Stage II Breast Cancer Undergoing Chemotherapy
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Physical Activity Intervention to Prevent Weight Gain in Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2010-02
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 Physical activity may prevent or reduce weight gain in women receiving chemotherapy for early stage breast cancer
PURPOSE This randomized phase III trial is studying physical activity to see how well it works compared with usual care to prevent or reduce weight gain in women with stage I or stage II breast cancer undergoing chemotherapy
PURPOSE This randomized phase III trial is studying physical activity to see how well it works compared with usual care to prevent or reduce weight gain in women with stage I or stage II breast cancer undergoing chemotherapy
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility for conducting a clinical trial that uses a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer and prior to initiation of adjuvant chemotherapy hormonal therapy andor radiotherapy phase I
Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases weight gain in patients treated with adjuvant chemotherapy phase II
Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer differentially affects weight change in women who are premenopausal compared to those who are postmenopausal at diagnosis phase II
Secondary
Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases gains in adiposity in patients treated with adjuvant chemotherapy phase II
Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer differentially affects change in adiposity among women who are premenopausal compared to those who are postmenopausal at diagnosis phase II
Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases the frequency of depressive symptomology and improves quality of life among patients treated with adjuvant chemotherapy phase II
OUTLINE This is a randomized multicenter study Patients are stratified according to participating site and menopausal status premenopausal vs postmenopausal Patients are randomized to 1 of 2 intervention arms
Arm I exercise and usual care Patients receive usual care and are enrolled in an exercise and weight control program at Curves fitness center The Curves program which begins during the third week of study uses aerobic activity and resistance training to reduce weight and increase strength and fitness Patients exercise a minimum of 3 times per week approximately 30 minutes every time for up to 6 months in the absence of disease progression or unacceptable toxicity Patients physical activity is measured at baseline and at the 3- and 6-month follow-up visits
Patients also undergo behavior modification counseling with a study nurse to help them overcome the specific barriers to adhering to the recommended exercise routine Counseling sessions are conducted every 2 to 3 weeks during chemotherapy and at least monthly after completion of chemotherapy for up to 6 months starting within 2 weeks after randomization and prior to initiation of the Curves intervention
Arm II control usual care alone Patients receive usual care and general advice on coping with their breast cancer treatment for up to 6 months in the absence of disease progression or unacceptable toxicity Patients receive no counseling or recommendations concerning emotional and practical barriers encountered during breast cancer treatment
Dietary information is obtained from patients by telephone during three 24-hour dietary recalls performed within 2 weeks of baseline and at the 3-month and 6-month follow-up visits to estimate total energy intake throughout the study Patients complete questionnaires at baseline and periodically during study assessing demographic characteristics and established breast cancer risk factors medical history and health changes Weight adiposity as measured by waist circumference quality of life and depressive symptomology are assessed at baseline and at the 3- and 6-month follow-up visits
After completion of the study intervention patients are followed for up to 6 months
Primary
Determine the feasibility for conducting a clinical trial that uses a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer and prior to initiation of adjuvant chemotherapy hormonal therapy andor radiotherapy phase I
Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases weight gain in patients treated with adjuvant chemotherapy phase II
Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer differentially affects weight change in women who are premenopausal compared to those who are postmenopausal at diagnosis phase II
Secondary
Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases gains in adiposity in patients treated with adjuvant chemotherapy phase II
Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer differentially affects change in adiposity among women who are premenopausal compared to those who are postmenopausal at diagnosis phase II
Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases the frequency of depressive symptomology and improves quality of life among patients treated with adjuvant chemotherapy phase II
OUTLINE This is a randomized multicenter study Patients are stratified according to participating site and menopausal status premenopausal vs postmenopausal Patients are randomized to 1 of 2 intervention arms
Arm I exercise and usual care Patients receive usual care and are enrolled in an exercise and weight control program at Curves fitness center The Curves program which begins during the third week of study uses aerobic activity and resistance training to reduce weight and increase strength and fitness Patients exercise a minimum of 3 times per week approximately 30 minutes every time for up to 6 months in the absence of disease progression or unacceptable toxicity Patients physical activity is measured at baseline and at the 3- and 6-month follow-up visits
Patients also undergo behavior modification counseling with a study nurse to help them overcome the specific barriers to adhering to the recommended exercise routine Counseling sessions are conducted every 2 to 3 weeks during chemotherapy and at least monthly after completion of chemotherapy for up to 6 months starting within 2 weeks after randomization and prior to initiation of the Curves intervention
Arm II control usual care alone Patients receive usual care and general advice on coping with their breast cancer treatment for up to 6 months in the absence of disease progression or unacceptable toxicity Patients receive no counseling or recommendations concerning emotional and practical barriers encountered during breast cancer treatment
Dietary information is obtained from patients by telephone during three 24-hour dietary recalls performed within 2 weeks of baseline and at the 3-month and 6-month follow-up visits to estimate total energy intake throughout the study Patients complete questionnaires at baseline and periodically during study assessing demographic characteristics and established breast cancer risk factors medical history and health changes Weight adiposity as measured by waist circumference quality of life and depressive symptomology are assessed at baseline and at the 3- and 6-month follow-up visits
After completion of the study intervention patients are followed for up to 6 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA006927 | NIH | None | None |
| FCCC-FCRB-05-009 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006927 |