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Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy

NCT00087399 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2016-07-14

No results posted yet for this study

Summary

RATIONALE: Gabapentin may be effective in relieving hot flashes in women who have had breast cancer or who have concerns about taking hormone therapy to treat hot flashes. It is not yet known whether gabapentin is more effective with or without antidepressants in treating hot flashes.

PURPOSE: This randomized phase III trial is studying gabapentin and antidepressants to see how well they work compared to antidepressants alone in treating hot flashes in women who have had breast cancer or who have concerns about taking hormones to treat hot flashes.

Conditions

Interventions

DRUG

gabapentin

DRUG

antidepressant

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Charles L. Loprinzi, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00087399 on ClinicalTrials.gov