S9626: Megestrol in Treating Hot Flashes Following Treatment for Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00005975
First received: July 5, 2000
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

RATIONALE: Megestrol may be effective in treating hot flashes following treatment for breast cancer. It is not yet known which regimen of megestrol is most effective for hot flashes.

PURPOSE: Randomized phase III trial to compare the effectiveness of different doses of megestrol in treating hot flashes in patients who have undergone therapy for breast cancer.


Condition Intervention Phase
Breast Cancer
Hot Flashes
Drug: megestrol acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Phase III Trial of Placebo Versus Megestrol Acetate 20 MG/Day Versus Megestrol Acetate 40 MG/Day as Treatment for Symptoms of Ovarian Failure in Women Treated for Breast Cancer: SWOG Study S9626

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Effectiveness and duration of the benefit of placebo and 2 dose levels of megestrol acetate in reduction of severe and/or frequent hot flashes in patients with history of adequate local and regional treatment of invasive breast cancer [ Time Frame: 3, 6, and 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Document any effects of various dose levels of megestrol acetate on atrophic vaginitis and dyspareunia [ Time Frame: 3, 6, and 9 months ] [ Designated as safety issue: No ]
  • Evaluate toxicity of two dose levels of megestrol acetate relative to placebo [ Time Frame: 3, 6, and 9 months ] [ Designated as safety issue: Yes ]
  • Feasibility of accrual patients to placebo-controlled study [ Time Frame: At registration ] [ Designated as safety issue: No ]

Enrollment: 288
Study Start Date: April 1998
Study Completion Date: March 2002
Primary Completion Date: September 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Megestrol Acetate 20 mg/day
Double blinded study drug taken for 3 months
Drug: megestrol acetate
Double blinded in either 20mg/day or 40mg/day doses.
Other Name: NSC-71423
Active Comparator: Megestrol Acetate 40 mg/day
Double blinded drug taken for 3 months
Drug: megestrol acetate
Double blinded in either 20mg/day or 40mg/day doses.
Other Name: NSC-71423
Placebo Comparator: Placebo
Double blinded drug taken for 3 months

Detailed Description:

OBJECTIVES: I. Compare the effectiveness and duration of the benefit of placebo versus low dose megestrol versus high dose megestrol in the reduction of severe and/or frequent hot flashes in patients with previously treated invasive breast cancer. II. Document the effects of various dose levels of megestrol on atrophic vaginitis and dyspareunia in these patients. III. Evaluate the toxicity of this treatment in these patients.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to tamoxifen use (yes vs no), number of hot flashes per week (5-34 vs 35-63 vs more than 63), and duration of hot flashes (6 months or less vs longer than 6 months). Patients are randomized to one of three treatment arms. Arm I: Patients receive oral placebo daily. Arm II: Patients receive lower dose oral megestrol daily. Arm III: Patients receive higher dose oral megestrol daily. Patients who do not respond after 3 months of treatment receive an additional dose of oral megestrol daily. Treatment continues for a total of 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 months.

PROJECTED ACCRUAL: A total of 279 eligible patients (93 per arm) are expected to be accrued.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Diagnosis of infiltrating breast cancer (T1-3, N0-1, M0) treated with appropriate local and regional therapy Chemotherapy and/or surgery completed At least 10 hot flashes per week OR At least 5 severe or very severe hot flashes per week No prior participation in NCI sponsored breast cancer adjuvant protocol No recurrent or persistent vaginal bleeding If postmenopausal and had any vaginal bleeding within past year, then must have normal endometrial biopsy Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Pre or postmenopausal Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No history of deep vein thrombosis Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior malignancy in past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed At least 6 months since prior megestrol At least 1 week since prior nonestrogen containing steroid hormones (except tamoxifen) Concurrent tamoxifen allowed only if begun at least 4 months prior to study No other concurrent nonestrogen containing steroid hormones No concurrent estrogen or hormone replacement therapy Radiotherapy: Concurrent radiotherapy allowed Surgery: See Disease Characteristics Prior hysterectomy allowed No concurrent surgery Other: Concurrent nonhormonal prescription or nonprescription medications for hot flashes allowed (e.g., clonidine, ergotamine tartrate, vitamin E, or soy)

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005975

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: John W. Goodwin, MD Cancer Research for the Ozarks
  More Information

Additional Information:
Publications:
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00005975     History of Changes
Other Study ID Numbers: CDR0000067962, S9626, NCI-P00-0159, U10CA037429
Study First Received: July 5, 2000
Last Updated: January 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage I breast cancer
stage II breast cancer
hot flashes

Additional relevant MeSH terms:
Breast Neoplasms
Hot Flashes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Megestrol
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 01, 2014