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Pregabalin in Treating Women With Hot Flashes

Primary Purpose

Breast Cancer, Hot Flashes

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

pregabalin

placebo

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, hot flashes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

DISEASE CHARACTERISTICS:

Meeting 1 of the following criteria:
- History of breast cancer (currently without malignant disease)
- No history of breast cancer, but patient wishes to avoid estrogen due to a perceived increased risk of breast cancer
Bothersome hot flashes (defined by their occurrence ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention)
Presence of hot flashes for ≥ 1 month prior to study entry

PATIENT CHARACTERISTICS:

Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Life expectancy ≥ 6 months
Able to complete questionnaire(s) by themselves or with assistance
Women of childbearing potential not eligible (per the judgment of the attending clinician)
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

Sites / Locations

Mayo Clinic Scottsdale
Aurora Presbyterian Hospital
Boulder Community Hospital
Penrose Cancer Center at Penrose Hospital
St. Anthony Central Hospital
Porter Adventist Hospital
Presbyterian - St. Luke's Medical Center
St. Joseph Hospital
Rose Medical Center
CCOP - Colorado Cancer Research Program
Swedish Medical Center
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
North Colorado Medical Center
Sky Ridge Medical Center
Hope Cancer Care Center at Longmont United Hospital
McKee Medical Center
St. Mary - Corwin Regional Medical Center
North Suburban Medical Center
Exempla Lutheran Medical Center
Mayo Clinic - Jacksonville
Rush-Copley Cancer Care Center
St. Joseph Medical Center
Graham Hospital
Memorial Hospital
Eureka Community Hospital
Galesburg Clinic, PC
Galesburg Cottage Hospital
Mason District Hospital
Hopedale Medical Complex
Joliet Oncology-Hematology Associates, Limited - West
McDonough District Hospital
BroMenn Regional Medical Center
Community Cancer Center
Community Hospital of Ottawa
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Cancer Treatment Center at Pekin Hospital
Proctor Hospital
CCOP - Illinois Oncology Research Association
Oncology Hematology Associates of Central Illinois, PC - Peoria
Methodist Medical Center of Illinois
OSF St. Francis Medical Center
Illinois Valley Community Hospital
Perry Memorial Hospital
St. Margaret's Hospital
Carle Cancer Center at Carle Foundation Hospital
CCOP - Carle Cancer Center
Elkhart General Hospital
Howard Community Hospital
Center for Cancer Therapy at LaPorte Hospital and Health Services
Saint Anthony Memorial Health Centers
CCOP - Northern Indiana CR Consortium
Memorial Hospital of South Bend
Saint Joseph Regional Medical Center
South Bend Clinic
Cedar Rapids Oncology Associates
Mercy Capitol Hospital
CCOP - Iowa Oncology Research Association
John Stoddard Cancer Center at Iowa Methodist Medical Center
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Medical Oncology and Hematology Associates at Mercy Cancer Center
Mercy Cancer Center at Mercy Medical Center - Des Moines
John Stoddard Cancer Center at Iowa Lutheran Hospital
McCreery Cancer Center at Ottumwa Regional
Siouxland Hematology-Oncology Associates, LLP
Mercy Medical Center - Sioux City
St. Luke's Regional Medical Center
Cancer Center of Kansas, PA - Chanute
Cancer Center of Kansas, PA - Dodge City
Cancer Center of Kansas, PA - El Dorado
Cancer Center of Kansas-Independence
Cancer Center of Kansas, PA - Kingman
Southwest Medical Center
Cancer Center of Kansas, PA - Newton
Cancer Center of Kansas, PA - Parsons
Cancer Center of Kansas, PA - Pratt
Cancer Center of Kansas, PA - Salina
Cancer Center of Kansas, PA - Wellington
Associates in Womens Health, PA - North Review
Cancer Center of Kansas, PA - Medical Arts Tower
Cancer Center of Kansas, PA - Wichita
CCOP - Wichita
Via Christi Cancer Center at Via Christi Regional Medical Center
Cancer Center of Kansas, PA - Winfield
Hickman Cancer Center at Bixby Medical Center
Saint Joseph Mercy Cancer Center
CCOP - Michigan Cancer Research Consortium
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Green Bay Oncology, Limited - Escanaba
Genesys Hurley Cancer Institute
Hurley Medical Center
Van Elslander Cancer Center at St. John Hospital and Medical Center
Dickinson County Healthcare System
Foote Memorial Hospital
Haematology-Oncology Associates of Ohio and Michigan, PC
Sparrow Regional Cancer Center
St. Mary Mercy Hospital
Community Cancer Center of Monroe
Mercy Memorial Hospital - Monroe
St. Joseph Mercy Oakland
Mercy Regional Cancer Center at Mercy Hospital
Seton Cancer Institute at Saint Mary's - Saginaw
Lakeland Regional Cancer Care Center - St. Joseph
St. John Macomb Hospital
MeritCare Bemidji
Fairview Ridges Hospital
Mercy and Unity Cancer Center at Mercy Hospital
Fairview Southdale Hospital
Mercy and Unity Cancer Center at Unity Hospital
Immanuel St. Joseph's
Minnesota Oncology Hematology, PA - Maplewood
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Mayo Clinic Cancer Center
CentraCare Clinic - River Campus
Coborn Cancer Center
CCOP - Metro-Minnesota
Park Nicollet Cancer Center
United Hospital
Ridgeview Medical Center
Minnesota Oncology Hematology, PA - Woodbury
Missouri Baptist Cancer Center
Arch Medical Services, Incorporated at Center for Cancer Care and Research
CCOP - Montana Cancer Consortium
Hematology-Oncology Centers of the Northern Rockies - Billings
Northern Rockies Radiation Oncology Center
St. Vincent Healthcare Cancer Care Services
Billings Clinic - Downtown
Bozeman Deaconess Cancer Center
St. James Healthcare Cancer Care
Great Falls Clinic - Main Facility
Northern Montana Hospital
St. Peter's Hospital
Glacier Oncology, PLLC
Kalispell Medical Oncology at KRMC
Kalispell Regional Medical Center
Community Medical Center
Guardian Oncology and Center for Wellness
Montana Cancer Specialists at Montana Cancer Center
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Cancer Resource Center - Lincoln
CCOP - Missouri Valley Cancer Consortium
Creighton University Medical Center
Bismarck Cancer Center
Medcenter One Hospital Cancer Care Center
Mid Dakota Clinic, PC
St. Alexius Medical Center Cancer Center
CCOP - MeritCare Hospital
MeritCare Broadway
Mary Rutan Hospital
Wood County Oncology Center
Adena Regional Medical Center
Riverside Methodist Hospital Cancer Care
CCOP - Columbus
Grant Medical Center Cancer Care
Mount Carmel Health - West Hospital
Doctors Hospital at Ohio Health
Grady Memorial Hospital
Fairfield Medical Center
Lima Memorial Hospital
Strecker Cancer Center at Marietta Memorial Hospital
Northwest Ohio Oncology Center
St. Luke's Hospital
Licking Memorial Cancer Care Program at Licking Memorial Hospital
St. Charles Mercy Hospital
Toledo Clinic - Oregon
North Coast Cancer Care, Incorporated
Mercy Medical Center
Community Hospital of Springfield and Clark County
Flower Hospital Cancer Center
Mercy Hospital of Tiffin
Toledo Hospital
St. Vincent Mercy Medical Center
Medical University of Ohio Cancer Center
CCOP - Toledo Community Hospital
Toledo Clinic, Incorporated - Main Clinic
Fulton County Health Center
Mount Carmel St. Ann's Cancer Center
Genesis - Good Samaritan Hospital
Legacy Mount Hood Medical Center
Providence Milwaukie Hospital
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Providence Cancer Center at Providence Portland Medical Center
Adventist Medical Center
CCOP - Columbia River Oncology Program
Providence St. Vincent Medical Center
Legacy Emanuel Hospital and Health Center and Children's Hospital
Legacy Meridian Park Hospital
Geisinger Cancer Institute at Geisinger Health
Geisinger Hazleton Cancer Center
Geisinger Medical Group - Scenery Park
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Mercy Hospital at Wilkes-Barre
Rapid City Regional Hospital
Avera Cancer Institute
Medical X-Ray Center, PC
Sanford Cancer Center at Sanford USD Medical Center
Fredericksburg Oncology, Incorporated
Southwest Washington Medical Center Cancer Center
Central Wisconsin Cancer Program at Agnesian HealthCare
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay Oncology, Limited at St. Mary's Hospital
St. Mary's Hospital Medical Center - Green Bay
St. Vincent Hospital Regional Cancer Center
Bay Area Cancer Care Center at Bay Area Medical Center
Green Bay Oncology, Limited - Oconto Falls
Green Bay Oncology, Limited - Sturgeon Bay
Welch Cancer Center at Sheridan Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Pregabalin75

Pregabalin150

Placebo

Arm Description

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

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

Patients receive oral placebo twice daily for 6 weeks.

Outcomes

Primary Outcome Measures

Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).

Hot flash activity will be analyzed in a number of ways. For the primary analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).

Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).

Hot flash activity will be analyzed in a number of ways. For the primary analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).

Secondary Outcome Measures

Numerical Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).

The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).

Percent Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).

Comparison of 75 mg of Pregabalin vs Placebo, Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).

Hot flash activity will be analyzed in a number of ways. For the this analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).

Comparison of 75 mg of Pregabalin vs Placebo. Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).

Hot flash activity will be analyzed in a number of ways. For the this analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).

Toxicity Data for the Individual Study Arms From the Symptom Experience Diary .

A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire weekly. This patient diary contains several questions related to potential side effects and side benefits of pregabalin measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity, providing numbers representing the worst median changes from baseline minus Maximum (Week 1-6) Symptom Experience Diary Distributions).

Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment

Endpoints for this analysis will be median change from baseline to after week 6 of treatment. Hot Flash Related Daily Interference Scale is used to evaluate the specific impact of the study treatment on the effect hot flashes have on various life activities such as work, social, leisure and relationships. Responses to the questionnaire are recorded on a 0 to 10 scale. Lower scores are better.

Full Information

NCT ID

NCT00702949

First Posted

June 19, 2008

Last Updated

July 1, 2016

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00702949

Brief Title

Pregabalin in Treating Women With Hot Flashes

Official Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of Pregabalin for Alleviating Hot Flashes

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Hot Flashes

Keywords

breast cancer, hot flashes

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

207 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pregabalin75

Arm Type

Experimental

Arm Description

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

Arm Title

Pregabalin150

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients receive oral placebo twice daily for 6 weeks.

Intervention Type

Drug

Intervention Name(s)

pregabalin

Intervention Description

Given orally

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

Given orally

Primary Outcome Measure Information:

Title

Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).

Description

Time Frame