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Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer Clinical research trials and Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer. Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer clinical trial. Subjects frequently get the best healthcare possible for their Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer  Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer
Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer
For Condition: stage 1 breast cancer,ductal breast carcinoma,menopausal symptoms,Hot Flashes,stage 2 breast cancer,breast cancer in situ
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Hormone replacement therapy may be effective in managing the hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of hormone replacement therapy in managing hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.
Details: OBJECTIVES: I. Determine the efficacy of hormone replacement therapy in managing hot flashes and menopausal vaginal symptoms in postmenopausal women with a history of node-negative invasive carcinoma or ductal carcinoma in situ of the breast who are receiving adjuvant tamoxifen. II. Determine the effect of this regimen on blood coagulation and lipid profiles in these patients. III. Determine the quality of life of patients treated with this regimen. PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior hysterectomy (yes vs no), symptom complex (vasomotor vs vaginal vs both), duration of hot flashes (less than 1 year or no hot flashes vs 1 year or more), and average daily number of hot flashes (less than 10 or none vs 10 or more). Patients are randomized to one of two treatment arms. Arm I: Patients who have not undergone prior hysterectomy receive oral medroxyprogesterone once daily for 6 months. If, after 1 month, symptoms do not resolve, patients receive oral conjugated estrogens once daily in addition to medroxyprogesterone for 5 months. Patients who have undergone prior hysterectomy receive oral conjugated estrogens once daily for 6 months. Arm II: Patients receive oral placebo once daily for 6 months. Quality of life is assessed at baseline and months 1, 2, 3, and 6. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed node-negative invasive carcinoma or ductal carcinoma in situ of the breast - No contralateral breast cancer - No recurrent or metastatic disease - Completion of active non-hormonal therapy for breast cancer - Receiving tamoxifen (20 mg/day) for at least 3 months prior to study and plan to continue drug while on study - Hot flashes severe enough to seek medical intervention (at least 7-8 moderate to severe hot flashes per day or 60 per week at baseline) AND/OR - Vaginal symptoms, including dyspareunia, vaginal dryness, irritation, or thinning due to estrogen deficiency - If uterus present, no prior histologically confirmed adenomatous or atypical endometrial hyperplasia or endometrial carcinoma AND no concurrent endometrial cancer confirmed by pelvic exam within the past year - No active endometriosis - No unexplained vaginal bleeding - Hormone receptor status: Estrogen and progesterone receptor status known for patients with invasive breast cancer --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: See Disease Characteristics; No other concurrent estrogen or hormone replacement therapy; No concurrent clonidine, bellergal, progestational agent, or methyldopa for hot flashes; No concurrent topical vaginal estrogen cream (e.g., Estring or Vagifem) for patients with vaginal symptoms only - Radiotherapy: Not specified - Surgery: At least 4 weeks since prior surgery - Other: At least 12 months since prior treatment for congestive heart failure; Concurrent selective serotonin reuptake inhibitors (SSRI) or antidepressants with SSRI activity allowed if begun at least 3 months prior to study and continue during study --Patient Characteristics-- - Age: 18 and over - Sex: Female - Menopausal status: Postmenopausal; No menstrual period for more than 12 months OR prior bilateral oophorectomy; Must be over 55 years of age OR have documented follicle-stimulating hormone levels in postmenopausal range if one or both ovaries remain after prior hysterectomy - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Cardiovascular: No prior superficial or deep venous or arterial thrombosis; No serious venous stasis disease - Pulmonary: No pulmonary embolus - Other: Must be able to read and speak English; No lower extremity trauma, swelling, or tenderness within the past 4 weeks; No active gallbladder disease; No migraine headaches; No other prior malignancy unless curatively treated with no evidence of recurrence; No concurrent seizure disorder requiring anti-seizure medication
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MelodyCobleigh, Study Chair, Eastern Cooperative Oncology Group
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: CDR0000069015; NCI-P01-0194,E-2193
Study Start Date: September 2000
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026286
Other Hot Flashes Studies:
1. Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery
2. Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
3. Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer
4. 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
5. Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer
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Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer
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