Clinical trial · Interventional
Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy
A Phase III Randomized, Trial of Gabapentin Alone or in Conjunction With an Antidepressant in the Management of Hot Flashes in Women Who Have Inadequate Control With an Antidepressant Alone
NCT00087399CI-TRIAL-00023042completedPhase 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 women who have had breast cancer or who have concerns about taking hormone therapy to treat hot flashes. It is not yet known whether gabapentin is more effective with or without antidepressants in treating hot flashes. PURPOSE: This randomized phase III trial is studying gabapentin and antidepressants to see how well they work compared to antidepressants alone in treating hot flashes in women who have had breast cancer or who have concerns about taking hormones to treat hot flashes.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hot Flashes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antidepressant | Drug | — | UNRESOLVED |
| gabapentin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- gabapentin + antidepressant
- description
- Patients continue to receive the same antidepressant (as before study entry) on weeks 1-5. During weeks 2-5, patients also receive oral gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity. Patients complete a hot flash diary at baseline and then daily during study treatment.
- interventionNames
- Drug: gabapentin
- Drug: antidepressant
- type
- EXPERIMENTAL
- label
- gabapentin
- description
- Patients receive gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone. Patients complete a hot flash diary at baseline and then daily during study treatment.
- interventionNames
- Drug: gabapentin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* History of breast cancer OR a concern about taking hormonal therapy due to a fear of developing breast cancer
* Experiencing bothersome hot flashes, defined as patient-reported occurrence ≥ 14 times per week AND sufficiently severe to prompt desire for additional therapeutic intervention despite current use of an antidepressant
* Currently (≥ 2 weeks) being treated with a stable dose of an antidepressant
* No monoamine oxidase inhibitors or tricyclics
* No current evidence of malignant disease
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Performance status
* ECOG 0-1
Life expectancy
* At least 6 months
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Chemotherapy
* More than 4 weeks since prior antineoplastic chemotherapy
* No concurrent antineoplastic chemotherapy
Endocrine therapy
* More than 4 weeks since prior androgens, estrogens, or progestational agents
* More than 2 weeks since prior dehydroepiandrosterone (DHEA) for treatment of hot flashes
* No concurrent androgens, estrogens, or progestational agents, including oral contraceptives
* No concurrent DHEA for treatment of hot flashes
* Concurrent tamoxifen, raloxifene, or aromatase inhibitor therapy allowed if on a stable dose for at least 4 weeks prior to study entry and during study treatment
Other
* No prior gabapentin
* More than 2 weeks since other prior treatment for hot flashes (e.g., clonidine or Bellergal-S®)
* Concurrent vitamin E or soy supplements allowed if on a stable dose for at least 1 month prior to study entry and during study treatment
* No other concurrent treatment for hot flashes (e.g., clonidine or Bellergal-S®)
* No other concurrent antidepressantsReferences
Publications (2)
- RESULTLoprinzi CL, Kugler JW, Barton DL, Dueck AC, Tschetter LK, Nelimark RA, Balcueva EP, Burger KN, Novotny PJ, Carlson MD, Duane SF, Corso SW, Johnson DB, Jaslowski AJ. Phase III trial of gabapentin alone or in conjunction with an antidepressant in the management of hot flashes in women who have inadequate control with an antidepressant alone: NCCTG N03C5. J Clin Oncol. 2007 Jan 20;25(3):308-12. doi: 10.1200/JCO.2006.07.5390. Epub 2006 Dec 4. PMID 17146104
- RESULTLoprinzi CL, Kugler JW, Barton DL, et al.: Phase III randomized trial to evaluate the use of gabapentin alone vs with continuing an antidepressant in women failing an antidepressant for the treatment of hot flashes: North Central Cancer Treatment Group study N03C5. [Abstract] J Clin Oncol 24 (Suppl 18): A-526, 9s, 2006.