Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer - 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:	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
Cancer-Related Problem/Condition Prostate Cancer	Drug: gabapentin	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Gabapentin

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 Trial of Gabapentin in the Management of Hot Flashes in Men

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

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

Study ID Numbers:	CDR0000069107, NCCTG-N00CB, NCI-P01-0199
Study First Received:	January 4, 2002
Last Updated:	October 25, 2008
ClinicalTrials.gov Identifier:	NCT00028574
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

Study placed in the following topic categories:

Excitatory Amino Acids
Calcium, Dietary
Signs and Symptoms
Prostatic Diseases
Genital Neoplasms, Male
Gabapentin

Hot Flashes
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Cardiovascular Agents
Antimanic Agents

Pharmacologic Actions
Membrane Transport Modulators
Neoplasms
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009