Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02819921
Previous Study | Return to List | Next Study

Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02819921
Recruitment Status : Terminated (Difficulty in Recruiting Research Participants)
First Posted : June 30, 2016
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
Korea Cancer Center Hospital
Pfizer
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE June 24, 2016
First Posted Date  ICMJE June 30, 2016
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE November 10, 2017
Actual Primary Completion Date March 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2017)
Reduction rate of hot flashes symptom score [ Time Frame: From baseline to Week 5 (Intervention is started from Week 1) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
  • Average Daily Number of Hot Flashes [ Time Frame: From baseline to Week 13 (Intervention is started from Week 1) ]
    Participants would complete self -report daily diary on which they record the number hot flashes and severity of hot flashes from baseline to Week 13.
  • Average Daily Severity of Hot Flashes [ Time Frame: From baseline to Week 13 (Intervention is started from Week 1) ]
    Participants would be instructed to fill out diaries at least daily and to characterize each hot flash as grade 1 (mild), 2 (moderate), 3 (severe), or 4 (very severe). The average daily severity of hot flashes for each week would be the sum of the daily severity scores divided by the number of days in that week with data.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2017)
  • Clinical impression state and change [ Time Frame: Week 1, Week 2, Week 5 ]
    Clinical global impression (CGI) would be used to assess clinical impression state and change.
  • Peripheral neuropathy [ Time Frame: Week 1, Week 2, Week 5 ]
    European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy(EORTC-QLQ-CIPN-20) would be used to assess peripheral neuropathy.
  • Depression [ Time Frame: Baseline, Week 2, Week 5 ]
    Patient health questionnaire (PHQ-9) would be used to assess mood status.
  • Anxiety [ Time Frame: Baseline, Week 2, Week 5 ]
    Generalized anxiety disorder-7 (GAD-7) would be used to assess anxiety.
  • Manic or Hypomanic symptoms. [ Time Frame: Baseline, Week 2, Week 5 ]
    Mood disorder questionnaire (MDQ) would be used to assess manic or hypomanic symptoms.
  • Sleep quality [ Time Frame: Baseline, Week 2, Week 5 ]
    Pittsburgh sleep quality index (PSQI) would be used to assess sleep quality.
  • Chonotype [ Time Frame: Baseline ]
    Morningness-Eveningness questionnaire (MEQ) would be used to assess chronotype.
  • Circadian misalignment [ Time Frame: Baseline, Week 2, Week 5 ]
    Munich Chronotype Questionnaire (MCTQ) would be used to assess circadian misalignment.
  • Fatigue [ Time Frame: Baseline, Week 2, Week 5 ]
    Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) would be used to assess fatigue.
  • Quality of life [ Time Frame: Baseline, Week 2, Week 5 ]
    Functional Assessment of Cancer Therapy-Breast (FACT-B) would be used to assess quality of life.
  • Beliefs about medicines [ Time Frame: Baseline ]
    Beliefs about Medicines Questionnaire (BMQ) would be used to assess beliefs about medicines.
  • Illness perception [ Time Frame: Baseline ]
    Brief Illness Perception Questionnaire (BIPQ) would be used to assess illness perception.
  • Social support [ Time Frame: Baseline ]
    Multidimensional Scale of Perceived Social Support (MSPSS) would be used to assess social supports.
  • Body image [ Time Frame: Baseline ]
    Body Image Scale (BIS) would be used to assess body image.
  • Resilience [ Time Frame: Baseline ]
    Connor-Davidson Resilience Scale (CDRS) would be used to assess resilience.
  • Hormonal level [ Time Frame: Week 2 ]
    Serum estradiol, follicle-stimulating hormone (FSH) and anti-Müllerian hormone (AMH) levels would be used to examine pathophysiological mechanisms associated with the presence of hot flashes, mood status and desvenlafaxine treatment.
  • Genetic polymorphism [ Time Frame: Week 2 ]
    estrogen receptors (ESR1 PvuII; rs#2234693 and XbaI; rs#9340799 and ESR2-02; rs#4986938) and serotonin transporter gene (SLC6A4; rs#11080121) would be used to examine pathophysiological mechanisms associated with the presence of hot flashes, mood status and desvenlafaxine treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
  • Clinical impression state and change [ Time Frame: Baseline, Week 2, Week 7, Week 13 ]
    Clinical global impression (CGI) would be used to assess clinical impression state and change.
  • Depression [ Time Frame: Baseline, Week 2, Week 7, Week 13 ]
    Patient health questionnaire (PHQ-9) would be used to assess mood status.
  • Anxiety and depression [ Time Frame: Baseline, Week 2, Week 7, Week 13 ]
    Hospital anxiety and depression scale (HADS) would be used to assess depression and anxiety.
  • Fatigue [ Time Frame: Baseline, Week 2, Week 7, Week 13 ]
    Fatigue severity scale (FSS) would be used to assess fatigue.
  • Sleep quality [ Time Frame: Baseline, Week 2, Week 7, Week 13 ]
    Pittsburgh sleep quality index (PSQI) would be used to assess sleep quality.
  • Quality of life [ Time Frame: Baseline, Week 2, Week 7, Week 13 ]
    Functional assessment of cancer therapy - breast (FACT-B) would be used to assess quality of life.
  • Perceived cognition [ Time Frame: Baseline, Week 2, Week 7, Week 13 ]
    Functional assessment of cancer therapy - cognition (FACT-Cog) would be used to assess perceived cognition.
  • Hormonal level [ Time Frame: Week 7 ]
    Serum estradiol level would be used to examine pathophysiological mechanisms associated with the presence of hot flashes, mood status and desvenlafaxine treatment.
  • Genetic polymorphism [ Time Frame: Week 7 ]
    estrogen receptors (ESR1 PvuII; rs#2234693 and XbaI; rs#9340799 and ESR2-02; rs#4986938) and serotonin transporter gene (SLC6A4; rs#11080121) would be used to examine pathophysiological mechanisms associated with the presence of hot flashes, mood status and desvenlafaxine treatment.
  • Daily activity [ Time Frame: From baseline to Week 13 (Intervention is started from Week 1) ]
    Wearable actigraphy would be used to assess psychophysiological patterns.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen
Official Title  ICMJE Desvenlafaxine for the Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen: a Randomized, Double-blind, Placebo-controlled Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hot Flashes
  • Breast Neoplasms
Intervention  ICMJE
  • Drug: Desvenlafaxine succinate 100mg
    Pristiq 100mg
  • Drug: Desvenlafaxine succinate 50mg
    Pristiq 50mg
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Desvenlafaxine succinate 100mg
    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.
    Intervention: Drug: Desvenlafaxine succinate 100mg
  • Experimental: Desvenlafaxine succinate 50mg
    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.
    Intervention: Drug: Desvenlafaxine succinate 50mg
  • Placebo Comparator: Placebo
    50 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 18, 2019)
59
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2016)
200
Actual Study Completion Date  ICMJE June 15, 2019
Actual Primary Completion Date March 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02819921
Other Study ID Numbers  ICMJE WI209149
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE
  • Seoul National University Bundang Hospital
  • Korea Cancer Center Hospital
  • Pfizer
Investigators  ICMJE
Principal Investigator: Bong-Jin Hahm, M.D., Ph.D. Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP