Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019643
Status:
TERMINATED
Last Update Posted:
2023-10-31
First Post:
2007-03-02
Brief Title:
Factors Affecting Weight Gain in Women Receiving Adjuvant Chemotherapy for Breast Cancer
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Prospective Study of Potential Factors Affecting Weight in Breast Cancer Patients Receiving Adjuvant Chemotherapy
Status:
TERMINATED
Status Verified Date:
2012-03
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 Chemotherapy may affect various factors that can lead to weight gain
PURPOSE Clinical trial to evaluate factors that may affect weight gain in women receiving adjuvant chemotherapy for stage I stage II or stage IIIA breast cancer
PURPOSE Clinical trial to evaluate factors that may affect weight gain in women receiving adjuvant chemotherapy for stage I stage II or stage IIIA breast cancer
Detailed Description:
OBJECTIVES I Evaluate the relative contributions of factors that may lead to weight gain in breast cancer patients receiving adjuvant chemotherapy Factors examined include Hormonal and growth factor status follicle stimulating hormone total bound and free estradiol androgens sex hormone binding globulin thyroid hormones prolactin insulin-like growth factors I and II and plasma leptin Factors affecting energy intake or expenditure oral intake physical activity and resting metabolic rate Psychological factors depression and quality of life II Evaluate the effect of chemotherapy on hormonal and growth factor status in these patients
III Assess the impact of chemotherapy on bone marrow density in these patients
PROTOCOL OUTLINE
Data is collected from women diagnosed with primary breast cancer at 3 points 5 visits i after breast cancer surgery but before chemotherapy begins 2 visits to NIH day hospital 1 week apart ii 2-3 weeks after chemotherapy has ended 2 visits 1 week apart and iii 6 months after chemotherapy has ended 1 visit Tests conducted during these visits include evaluation of blood for hormones growth factors and leptin body composition by DXA visceral and subcutaneous abdominal adipose tissue by an axial CT scan and evaluation of resting metabolic rate and daily energy expenditure by a single administration of doubly labeled water at visits a and b during data collection timepoints 1 and 2 Questionnaires assessing epidemiologic risk factors for breast cancer dietary intake physical activity depression and quality of life are also administered at the three timepoints
PROJECTED ACCRUAL
A total of 140 patients will be accrued for this study within 1-2 years
III Assess the impact of chemotherapy on bone marrow density in these patients
PROTOCOL OUTLINE
Data is collected from women diagnosed with primary breast cancer at 3 points 5 visits i after breast cancer surgery but before chemotherapy begins 2 visits to NIH day hospital 1 week apart ii 2-3 weeks after chemotherapy has ended 2 visits 1 week apart and iii 6 months after chemotherapy has ended 1 visit Tests conducted during these visits include evaluation of blood for hormones growth factors and leptin body composition by DXA visceral and subcutaneous abdominal adipose tissue by an axial CT scan and evaluation of resting metabolic rate and daily energy expenditure by a single administration of doubly labeled water at visits a and b during data collection timepoints 1 and 2 Questionnaires assessing epidemiologic risk factors for breast cancer dietary intake physical activity depression and quality of life are also administered at the three timepoints
PROJECTED ACCRUAL
A total of 140 patients will be accrued for this study within 1-2 years
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 |
|---|---|---|---|
| CDR0000066928 | None | None | None |
| 99-C-0026 | None | None | None |
| NCI-99-C-0020 | None | None | None |