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

NCT ID: NCT00005975

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-30

Study Completion Date

2002-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Hot Flashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Megestrol Acetate/Placebo 20 mg/day

Double blinded Megestrol Acetate 20 mg/day or Megestrol Acetate Placebo 20 mg/day taken for 3 months

Group Type ACTIVE_COMPARATOR

Megestrol Acetate 20mg/day

Intervention Type DRUG

Double blinded Megestrol Acetate 20 mg/day

Megestrol Acetate Placebo 20 mg/day

Intervention Type DRUG

Megestrol Acetate Placebo 20 mg/day

Megestrol Acetate/Placebo 40 mg/day

Double blinded Megestrol Acetate 40 mg/day or Megestrol Acetate Placebo 40 mg/day taken for 3 months

Group Type ACTIVE_COMPARATOR

Megestrol Acetate 40 mg/day

Intervention Type DRUG

Double blinded Megestrol Acetate 40 mg/day

Megestrol Acetate Placebo 40 mg/day

Intervention Type DRUG

Megestrol Acetate Placebo 40 mg/day

Interventions

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Megestrol Acetate 20mg/day

Double blinded Megestrol Acetate 20 mg/day

Intervention Type DRUG

Megestrol Acetate 40 mg/day

Double blinded Megestrol Acetate 40 mg/day

Intervention Type DRUG

Megestrol Acetate Placebo 20 mg/day

Megestrol Acetate Placebo 20 mg/day

Intervention Type DRUG

Megestrol Acetate Placebo 40 mg/day

Megestrol Acetate Placebo 40 mg/day

Intervention Type DRUG

Other Intervention Names

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NSC-71423 NSC-71423 NSC-71423 NSC-71423

Eligibility Criteria

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Inclusion 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)
Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John W. Goodwin, MD

Role: STUDY_CHAIR

Cancer Research for the Ozarks

References

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Goodwin JW, Green SJ, Moinpour CM, Bearden JD 3rd, Giguere JK, Jiang CS, Lippman SM, Martino S, Albain KS. Phase III randomized placebo-controlled trial of two doses of megestrol acetate as treatment for menopausal symptoms in women with breast cancer: Southwest Oncology Group Study 9626. J Clin Oncol. 2008 Apr 1;26(10):1650-6. doi: 10.1200/JCO.2006.10.6179.

Reference Type RESULT
PMID: 18375894 (View on PubMed)

Other Identifiers

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S9626

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-P00-0159

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA037429

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000067962

Identifier Type: -

Identifier Source: org_study_id