ClinicalTrials.gov
ClinicalTrials.gov Menu

Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00028574
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 28, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

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 or disease Intervention/treatment Phase
Hot Flashes Prostate Cancer Drug: gabapentin Other: placebo Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men
Study Start Date : December 2001
Actual Primary Completion Date : December 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Gabapentin (28 days)
Oral Gabapentin 300 mg days 1-28
Drug: gabapentin
Active Comparator: Gabapentin (7, 21)
Oral Gabapentin 300 mg once daily on days 1-7 days and twice daily days 8-28
Drug: gabapentin
Active Comparator: Gabapentin (7, 7, 14)
Oral Gabapentin 300 mg once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28
Drug: gabapentin
Placebo Comparator: Placebo

Oral Placebo 300 mg on one of the following schedules:

  • once daily on days 1-28
  • once daily on days 1-7, twice daily on days 8-28
  • once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28
Other: placebo



Primary Outcome Measures :
  1. Hot flash reduction by diary scores at 4 weeks [ Time Frame: 5 weeks from study entry ]

Secondary Outcome Measures :
  1. Toxicity by questionnaires at 4 weeks [ Time Frame: 5 weeks from study entry ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Required characteristics:

  1. Men with a history of prostate cancer who have received or are receiving androgen ablation therapy.
  2. Must be on a stable dose of hormone therapy for the past 4 weeks and must not be planning on discontinuing hormone therapy throughout the duration of the randomized phase (5 weeks).
  3. Presence of hot flashes for ≥1 month prior to study entry.
  4. Bothersome hot flashes (defined by their occurrence ≥14 times per week and of sufficient severity to make the patient desire therapeutic intervention).
  5. Life expectancy ≥ 6 months.
  6. ECOG Performance Status (PS) 0 or 1.
  7. ≥18 years of age

Contraindications:

  1. History of renal insufficiency (defined as a creatinine ≥1.5 x UNL in the last two years).
  2. Any of the following current (≤ 4 weeks) or planned therapies:

    • Antineoplastic chemotherapy
    • Androgens
    • Estrogens
    • Progestational agents
  3. History of allergic or other adverse reaction to gabapentin.
  4. Prior use of gabapentin.
  5. Antidepressants (use is allowed if patient has been on a stable dose for ≥1 month and does not plan to modify this treatment during the next 5 weeks).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028574


  Show 170 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Charles Loprinzi, MD Mayo Clinic

Publications of Results:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00028574     History of Changes
Other Study ID Numbers: NCCTG-N00CB
NCCTG-N00CB
NCI-P01-0199
CDR0000069107 ( Registry Identifier: NCI Physician Data Query )
NCI-2012-02435 ( Registry Identifier: NCI Clinical Trials Reporting Program )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer
hot flashes

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