Pregabalin in Treating Women With Hot Flashes - Full Text View

Sponsors and Collaborators:	North Central Cancer Treatment Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00702949

Purpose

RATIONALE: Pregabalin may help relieve hot flashes in women who do not wish to take estrogen therapy for fear of increased risk of breast cancer. It is not yet known which dose of pregabalin may be more effective in treating hot flashes.

PURPOSE: This randomized phase III trial is studying the side effects of two doses of pregabalin and to see how well it works compared with a placebo in treating women with hot flashes.

Condition	Intervention	Phase
Breast Cancer Cancer-Related Problem/Condition	Drug: placebo Drug: pregabalin	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of Pregabalin for Alleviating Hot Flashes

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Hot flash score after 6 weeks of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Mood and hot flash-related daily interference on activities [ Designated as safety issue: No ]
Comparison of 75 mg of pregabalin vs placebo [ Designated as safety issue: No ]

Estimated Enrollment:	192
Study Start Date:	June 2008
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.	Drug: pregabalin Given orally
Arm II: Experimental Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.	Drug: pregabalin Given orally
Arm III: Placebo Comparator Patients receive oral placebo twice daily for 6 weeks.	Drug: placebo Given orally

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702949

Show 210 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles L. Loprinzi, MD

Mayo Clinic

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000598191, NCCTG-N07C1
Study First Received:	June 19, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00702949
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

breast cancer
breast cancer
hot flashes

Study placed in the following topic categories:

Signs and Symptoms
Skin Diseases
Hot Flashes

Pregabalin
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009