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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
1 other identifier
interventional
59
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedStudy Start
First participant enrolled
November 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2019
CompletedSeptember 20, 2019
September 1, 2019
1.3 years
June 24, 2016
September 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction rate of hot flashes symptom score
Participants would complete self -report daily diary on which they record the number and severities (1 - 4 points) of hot flashes from baseline to week 5. Each symptom severities are multiplied by the numbers of symptoms to determine the daily hot flashes symptom score. The mean of daily hot flashes symptom score of one week is calculated and regared as a hot flashes symptom score for the week. The efficacy of Desvenlafaxine is assessed by comparing the reduction rate of weekly hot flashes symptom score (= hot flashes symptom score at week 5 - hot flashes symptom score at baseline / hot flashes symptom score of baseline) for each group.
From baseline to Week 5 (Intervention is started from Week 1)
Secondary Outcomes (17)
Clinical impression state and change
Week 1, Week 2, Week 5
Peripheral neuropathy
Week 1, Week 2, Week 5
Depression
Baseline, Week 2, Week 5
Anxiety
Baseline, Week 2, Week 5
Manic or Hypomanic symptoms.
Baseline, Week 2, Week 5
- +12 more secondary outcomes
Study Arms (3)
Desvenlafaxine succinate 100mg
EXPERIMENTALTitration 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.
Desvenlafaxine succinate 50mg
EXPERIMENTAL50 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.
Placebo
PLACEBO COMPARATOR50 mg placebo tablet once daily for 1 week, then 2 tablets of 50mg placebo tablet once daily for 3 weeks, then 50 mg placebo tablet once daily for 3 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Seoul National University Bundang Hospitalcollaborator
- Korea Cancer Center Hospitalcollaborator
- Pfizercollaborator
Study Sites (3)
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Related Publications (1)
Kim 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: 39019875DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bong-Jin Hahm, M.D., Ph.D.
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2016
First Posted
June 30, 2016
Study Start
November 10, 2017
Primary Completion
March 15, 2019
Study Completion
June 15, 2019
Last Updated
September 20, 2019
Record last verified: 2019-09