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Trial record 4 of 89 for:    DESVENLAFAXINE

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

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.

Condition or disease Intervention/treatment Phase
Hot Flashes Breast Neoplasms Drug: Desvenlafaxine succinate 100mg Drug: Desvenlafaxine succinate 50mg Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Desvenlafaxine for the Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen: a Randomized, Double-blind, Placebo-controlled Study
Actual Study Start Date : November 10, 2017
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
Drug: Desvenlafaxine succinate 100mg
Pristiq 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.
Drug: Desvenlafaxine succinate 50mg
Pristiq 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.
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. Depression [ Time Frame: Baseline, Week 2, Week 5 ]
    Patient health questionnaire (PHQ-9) would be used to assess mood status.

  4. Anxiety [ Time Frame: Baseline, Week 2, Week 5 ]
    Generalized anxiety disorder-7 (GAD-7) would be used to assess anxiety.

  5. Manic or Hypomanic symptoms. [ Time Frame: Baseline, Week 2, Week 5 ]
    Mood disorder questionnaire (MDQ) would be used to assess manic or hypomanic symptoms.

  6. Sleep quality [ Time Frame: Baseline, Week 2, Week 5 ]
    Pittsburgh sleep quality index (PSQI) would be used to assess sleep quality.

  7. Chonotype [ Time Frame: Baseline ]
    Morningness-Eveningness questionnaire (MEQ) would be used to assess chronotype.

  8. Circadian misalignment [ Time Frame: Baseline, Week 2, Week 5 ]
    Munich Chronotype Questionnaire (MCTQ) would be used to assess circadian misalignment.

  9. Fatigue [ Time Frame: Baseline, Week 2, Week 5 ]
    Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) would be used to assess fatigue.

  10. 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.

  11. Beliefs about medicines [ Time Frame: Baseline ]
    Beliefs about Medicines Questionnaire (BMQ) would be used to assess beliefs about medicines.

  12. Illness perception [ Time Frame: Baseline ]
    Brief Illness Perception Questionnaire (BIPQ) would be used to assess illness perception.

  13. Social support [ Time Frame: Baseline ]
    Multidimensional Scale of Perceived Social Support (MSPSS) would be used to assess social supports.

  14. Body image [ Time Frame: Baseline ]
    Body Image Scale (BIS) would be used to assess body image.

  15. Resilience [ Time Frame: Baseline ]
    Connor-Davidson Resilience Scale (CDRS) would be used to assess resilience.

  16. 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.

  17. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819921


Locations
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Korea, Republic of
National Cancer Center
Goyang, Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 13620
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Korea Cancer Center Hospital
Pfizer
Investigators
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Principal Investigator: Bong-Jin Hahm, M.D., Ph.D. Seoul National University Hospital

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02819921     History of Changes
Other Study ID Numbers: WI209149
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Seoul National University Hospital:
Hot Flashes
Breast Neoplasms
Tamoxifen
Desvenlafaxine Succinate
Additional relevant MeSH terms:
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Desvenlafaxine Succinate
Breast Neoplasms
Hot Flashes
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Signs and Symptoms
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Antidepressive Agents
Psychotropic Drugs