Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gabapentin; gamma-Aminobutyric Acid

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).