Pregabalin in Treating Women With Hot Flashes

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00702949
First received: June 19, 2008
Last updated: February 26, 2010
Last verified: February 2010
  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
Hot Flashes
Drug: pregabalin
Other: placebo
Phase 3

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

Resource links provided by NLM:


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
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
Drug: pregabalin
Given orally
Experimental: Arm II
Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
Drug: pregabalin
Given orally
Placebo Comparator: Arm III
Patients receive oral placebo twice daily for 6 weeks.
Other: 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 209 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Charles L. Loprinzi, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Loprinzi CL, Qin R, Stella PJ, et al.: Pregabalin for hot flashes in women: NCCTG trial N07C1. [Abstract] J Clin Oncol 27 (Suppl 15): A-9513, 2009.

Responsible Party: Charles L. Loprinzi, North Central Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT00702949     History of Changes
Other Study ID Numbers: CDR0000598191, NCCTG-N07C1
Study First Received: June 19, 2008
Last Updated: February 26, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer
hot flashes

Additional relevant MeSH terms:
Breast Neoplasms
Hot Flashes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 17, 2014