Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031720
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2002-03-08
Brief Title:
Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen
Status:
COMPLETED
Status Verified Date:
2016-07
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 Soy protein supplement may be effective in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast disease
PURPOSE Randomized phase II trial to determine the effectiveness of soy protein supplement in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast disease such as ductal hyperplasia or breast cancer
PURPOSE Randomized phase II trial to determine the effectiveness of soy protein supplement in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast disease such as ductal hyperplasia or breast cancer
Detailed Description:
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to duration of hot flashes less than 9 months vs 9 months or more and frequency of hot flashes 7 to 9 per day vs more than 9 per day For more information regarding the treatment regimens please see the treatment arms section
Primary objectives
1 To compare the effect of daily soy supplementation versus placebo on the daily number of hot flushes experienced by postmenopausal women taking tamoxifen measured at three months from baseline
2 To compare the effect of daily soy supplementation versus placebo on hot flush severity as measured by the average daily hot flash score in this population of women measured at three months from baseline
Secondary objectives
1 To evaluate the effect of soy supplementation as compared to women randomized to placebo on quality of life as measured by the Medical Outcomes Study MOS sleep subscale the Mental Health Inventory MHI the CES-D Short Form the Menopause and Reproductive Health Questionnaire and the General Quality of Life Form
2 To measure the effect of soy supplementation as compared to women randomized to placebo on serum isoflavones estradiol SHBG IGF1 and IGFBP3 levels as measures of hormonal change
3 To estimate the effect of daily soy supplementation versus placebo on the time to first relief of hot flushes
A total of 112 patients accrued on this study Patients were followed 6 months post-randomization
Primary objectives
1 To compare the effect of daily soy supplementation versus placebo on the daily number of hot flushes experienced by postmenopausal women taking tamoxifen measured at three months from baseline
2 To compare the effect of daily soy supplementation versus placebo on hot flush severity as measured by the average daily hot flash score in this population of women measured at three months from baseline
Secondary objectives
1 To evaluate the effect of soy supplementation as compared to women randomized to placebo on quality of life as measured by the Medical Outcomes Study MOS sleep subscale the Mental Health Inventory MHI the CES-D Short Form the Menopause and Reproductive Health Questionnaire and the General Quality of Life Form
2 To measure the effect of soy supplementation as compared to women randomized to placebo on serum isoflavones estradiol SHBG IGF1 and IGFBP3 levels as measures of hormonal change
3 To estimate the effect of daily soy supplementation versus placebo on the time to first relief of hot flushes
A total of 112 patients accrued on this study Patients were followed 6 months post-randomization
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 |
|---|---|---|---|
| CDR0000069219 | REGISTRY | NCI Physicians Data Query | httpsreporternihgovquickSearchU10CA076001 |
| U10CA076001 | NIH | None | None |
| CALGB-79805 | None | None | None |
| NCI-P02-0206 | None | None | None |