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Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: January 4, 2002   Last Updated: September 16, 2009   History of Changes
Sponsor: North Central Cancer Treatment Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028574
  Purpose

RATIONALE: Gabapentin may be effective in relieving hot flashes in men who have prostate cancer. It is not yet known which regimen of gabapentin is most effective in treating hot flashes.

PURPOSE: Randomized phase III trial to compare different regimens of gabapentin in treating men who have prostate cancer.


Condition Intervention Phase
Hot Flashes
Prostate Cancer
 Drug: gabapentin
 Phase III

Study Type: Interventional
Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title: A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Gabapentin
U.S. FDA Resources

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

Primary Outcome Measures:
  • Hot flash reduction by diary scores at 4 weeks

Secondary Outcome Measures:
  • Toxicity by questionnaires at 4 weeks

Estimated Enrollment: 220
Study Start Date: December 2001
Detailed Description:

OBJECTIVES:

  • Determine the effectiveness of gabapentin in managing hot flashes in men with prostate cancer.
  • Determine the response of patients to this drug.
  • Determine the toxicity of this drug in these patients.
  • Determine the quality of life of patients treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to the number of hot flashes per day (2-3 vs 4-9 vs 10 or more) and duration of hot flash symptoms (less than 9 months vs 9 months or more). Patients are randomized to one of four treatment arms.

All patients are observed for 7 days prior to drug administration in order to collect baseline hot flash information.

  • Arm I: Patients receive oral gabapentin once daily on days 1-28.
  • Arm II: Patients receive oral gabapentin once daily on days 1-7 and twice daily on days 8-28.
  • Arm III: Patients receive oral gabapentin once daily on days 1-7, twice daily on days 8-14, and three times daily on days 15-28.
  • Arm IV: Patients receive oral placebo on one of three schedules corresponding to arms I-III.

Patients in all arms may continue therapy with gabapentin for an additional 8 weeks.

Quality of life is assessed at baseline, day 28, and at the end of the additional 8 weeks.

Patients are followed at 6, 12, and 24 months.

PROJECTED ACCRUAL: A total of 220 patients (55 per treatment arm) will be accrued for this study within 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of prostate cancer
  • Received or are currently receiving androgen ablation therapy

  • Hot flashes for at least 1 month

    • At least 14 times per week and severe enough to require therapeutic intervention

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 6 months

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Creatinine < 1.5 times upper limit of normal over the past 2 years

Other:

  • No prior allergic or adverse reaction to gabapentin

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior antineoplastic chemotherapy
  • No concurrent antineoplastic chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior androgens, estrogens, or progestational agents
  • No concurrent androgens, estrogens, or progestational agents
  • Concurrent hormonal therapy allowed if on stable dose for at least 4 weeks and plan to continue therapy throughout study

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No prior gabapentin
  • No other concurrent treatment for hot flashes
  • Concurrent antidepressants allowed if on stable dose for at least 1 month and plan to continue therapy throughout study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028574

  Show 170 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Investigators
Study Chair: Charles L. Loprinzi, MD Mayo Clinic
Investigator: Debra Barton, RN, PhD, AOCN Mayo Clinic
  More Information

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

Publications:
Loprinzi CL, Dueck AC, Khoyratty BS, Barton DL, Jafar S, Rowland KM Jr, Atherton PJ, Marsa GW, Knutson WH, Bearden JD 3rd, Kottschade L, Fitch TR. A phase III randomized, double-blind, placebo-controlled trial of gabapentin in the management of hot flashes in men (N00CB). Ann Oncol. 2009 Mar;20(3):542-9. Epub 2009 Jan 6.

Study ID Numbers: CDR0000069107, NCCTG-N00CB, NCI-P01-0199
Study First Received: January 4, 2002
Last Updated: September 16, 2009
ClinicalTrials.gov Identifier: NCT00028574     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
 stage IV prostate cancer
recurrent prostate cancer
hot flashes

Additional relevant MeSH terms:
Neurotransmitter Agents
Prostatic Diseases
Genital Neoplasms, Male
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Hot Flashes
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Urogenital Neoplasms
Membrane Transport Modulators
Signs and Symptoms
 Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Analgesics
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Genital Diseases, Male
Pharmacologic Actions
Neoplasms
Anti-Anxiety Agents
Peripheral Nervous System Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009



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