Clinical trial · Interventional
Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men
NCT00028574CI-TRIAL-00022756completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hot Flashes | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gabapentin | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Gabapentin (28 days)
- description
- Oral Gabapentin 300 mg days 1-28
- interventionNames
- Drug: gabapentin
- type
- ACTIVE_COMPARATOR
- label
- Gabapentin (7, 21)
- description
- Oral Gabapentin 300 mg once daily on days 1-7 days and twice daily days 8-28
- interventionNames
- Drug: gabapentin
- type
- ACTIVE_COMPARATOR
- label
- Gabapentin (7, 7, 14)
- description
- Oral Gabapentin 300 mg once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (2)
- RESULTLoprinzi 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. doi: 10.1093/annonc/mdn644. Epub 2009 Jan 6. PMID 19129205
- RESULTMoraska AR, Atherton PJ, Szydlo DW, Barton DL, Stella PJ, Rowland KM Jr, Schaefer PL, Krook J, Bearden JD, Loprinzi CL. Gabapentin for the management of hot flashes in prostate cancer survivors: a longitudinal continuation Study-NCCTG Trial N00CB. J Support Oncol. 2010 May-Jun;8(3):128-32. PMID 20552926