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

Overview

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.

Full Title of Study: “Desvenlafaxine for the Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen: a Randomized, Double-blind, Placebo-controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 15, 2019

Interventions

  • Drug: Desvenlafaxine succinate 100mg
    • Pristiq 100mg
  • Drug: Desvenlafaxine succinate 50mg
    • Pristiq 50mg
  • Drug: Placebo
    • Placebo

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Collaborator
    • Seoul National University Bundang Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bong-Jin Hahm, M.D., Ph.D., Principal Investigator, Seoul National University Hospital

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