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Pregabalin in Treating Women ...

Pregabalin in Treating Women With Hot Flashes

Last Updated: 2016-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2015-03-31

Brief Summary

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RATIONALE: Pregabalin may help relieve hot flashes in women with a history of breast cancer or those who have no history and do not wish to take estrogen therapy for fear of increased risk of breast cancer. It is not yet known what dose of pregabalin may be more effective in treating hot flashes.

PURPOSE: This is a randomized phase III trial to determine the efficacy of two doses of pregabalin, in comparison to placebo, in the prevention of hot flashes.

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Detailed Description

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OBJECTIVES:

* To evaluate the efficacy of 150 mg of pregabalin versus placebo on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer.
* To evaluate the side effect profile of different doses of pregabalin in these patients.
* To evaluate the effect of 150 mg of pregabalin versus placebo on the secondary outcome of interference of activities from hot flashes in these patients.
* To evaluate the efficacy and side effect profile of 75 mg of pregabalin versus placebo in these patients.

OUTLINE: Patients are stratified according to age (18-49 years vs ≥ 50 years); selective estrogen-receptor modulator (i.e., tamoxifen or raloxifene) or aromatase inhibitor use (yes vs no); duration of hot flashes (\< 9 months vs ≥ 9 months); and frequency of hot flashes per 24-hour period (4-9 vs ≥ 10). Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
* Arm II: Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
* Arm III: Patients receive oral placebo twice daily for 6 weeks. Treatment in all arms continues in the absence of unacceptable toxicity.

Patients complete Hot Flash Diaries at baseline and once daily during treatment and the Symptom Experience Diary at baseline and once weekly during treatment. Patients also complete the Profile of Mood States and the Hot Flash Related Daily Interference Scale questionnaires at baseline and after completion of study treatment.

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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Pregabalin75

Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.

Group Type EXPERIMENTAL

pregabalin

Intervention Type DRUG

Given orally

Pregabalin150

Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.

Group Type EXPERIMENTAL

pregabalin

Intervention Type DRUG

Given orally

Placebo

Patients receive oral placebo twice daily for 6 weeks.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given orally

Interventions

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pregabalin

Given orally

Intervention Type DRUG

placebo

Given orally

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Serum creatinine ≤ 1.5 times upper limit of normal

PRIOR CONCURRENT THERAPY:

* No prior gabapentin or pregabalin
* More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, or progestational agents

* Vaginal estrogen is allowed if used for the past month and not planned to be discontinued
* Concurrent adjuvant targeted therapy (i.e., lapatinib, trastuzumab \[Herceptin®\]) allowed in patients with no evidence of disease
* Concurrent tamoxifen, raloxifene, or aromatase inhibitors on a constant dose for at least 4 weeks allowed provided the medication will not be stopped during the study period
* No concurrent or planned use of other agents for hot flashes except for any of the following:

* Stable dose of vitamin E is allowed as long as agent was started \> 30 days prior to study initiation and is to be continued throughout the study period
* Soy is allowed, if it is planned to be continued at the same dose during the study period
* Stable dose of antidepressants is allowed as long as it was started \> 30 days prior to study initiation and is to be continued at a stable dose throughout the study period

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Loprinzi, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

St. Anthony Central Hospital

Denver, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

St. Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

CCOP - Colorado Cancer Research Program

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

St. Mary - Corwin Regional Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

St. Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Howard Community Hospital

Kokomo, Indiana, United States

Site Status

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Saint Joseph Regional Medical Center

South Bend, Indiana, United States

Site Status

South Bend Clinic

South Bend, Indiana, United States

Site Status