Clinical trial · Interventional
Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen
Desvenlafaxine for the Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen: a Randomized, Double-blind, Placebo-controlled Study
NCT02819921CI-TRIAL-00040747terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty in Recruiting Research Participants
Summary
Brief summary (as posted)
This study is a randomized, placebo-controlled study of desvenlafaxine versus placebo. The purpose of this study is to determine if desvenlafaxine was effective in decreasing the frequency and severity of hot flashes in breast cancer patients taking tamoxifen.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hot Flashes | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Desvenlafaxine succinate 100mg | Drug | — | UNRESOLVED |
| Desvenlafaxine succinate 50mg | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Desvenlafaxine succinate 100mg
- description
- Titration with 50 mg Desvenlafaxine succinate tablet once daily for 1 week, then 2 tablets of 50mg Desvenlafaxine succinate tablet once daily for 3 weeks, then taper with 50 mg Desvenlafaxine succinate tablet once daily for 3 days.
- interventionNames
- Drug: Desvenlafaxine succinate 100mg
- type
- EXPERIMENTAL
- label
- Desvenlafaxine succinate 50mg
- description
- 50 mg Desvenlafaxine succinate tablet once daily for 1 week, then 1 tablets of 50mg Desvenlafaxine succinate tablet and 1 tablet of 50mg placebo tablet once daily for 3 weeks, then 50mg placebo tablet once daily for 3 days.
- interventionNames
- Drug: Desvenlafaxine succinate 50mg
- type
- PLACEBO_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: i. Women age 18 years and older with localized breast cancer. Histologic documentation of atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or invasive adenocarcinoma of the breast stages I-III A. ii. Current daily tamoxifen use (≥ 6 days/week). Any planned surgery, adjuvant chemotherapy or radiation must have been completed. iii. History of bothersome hot flushes: ≥ 14 hot flushes/week (average ≥ 2 hot flushes/day), sufficiently severe that intervention is desired. Participants must have had bothersome hot flushes for at least one month prior to enrollment. Exclusion Criteria: i. Women who is pregnant or breast feeding, or who has a history of seizure disorder or hepatic or renal insufficiency ii. Concurrent systemic hormone replacement therapy (estrogen, progestational agents, androgens) or use of corticosteroids iii. Concurrent use of other antidepressants, anxiolytics and antipsychotics, gabapentin, pregabalin and clonidine for treatment of hot flushes or depression. iv. Presense or past history of severe psychiatric symptoms such as hallucinations and delusions, manic episodes, or high suicide risk.
References
Publications (1)
- DERIVEDKim Y, Yeom CW, Lee HJ, Kim JH, Lee KM, Kim TY, Lee HB, Kim H, Im SA, Lee KH, Kim M, Han W, Moon HG, Spiegel D, Hahm BJ, Son KL. Differential effects of desvenlafaxine on hot flashes in women with breast cancer taking tamoxifen: a randomized controlled trial. NPJ Breast Cancer. 2024 Jul 17;10(1):59. doi: 10.1038/s41523-024-00668-w. PMID 39019875