Back to resultsDesvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen
Primary Purpose
Hot Flashes, Breast Neoplasms
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Desvenlafaxine succinate 100mg
Desvenlafaxine succinate 50mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes focused on measuring Hot Flashes, Breast Neoplasms, Tamoxifen, Desvenlafaxine Succinate
Eligibility 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.
Sites / Locations
- National Cancer Center
- Seoul National University Bundang Hospital
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Desvenlafaxine succinate 100mg
Desvenlafaxine succinate 50mg
Placebo
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Clinical impression state and change
Clinical global impression (CGI) would be used to assess clinical impression state and change.
Peripheral neuropathy
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
Patient health questionnaire (PHQ-9) would be used to assess mood status.
Anxiety
Generalized anxiety disorder-7 (GAD-7) would be used to assess anxiety.
Manic or Hypomanic symptoms.
Mood disorder questionnaire (MDQ) would be used to assess manic or hypomanic symptoms.
Sleep quality
Pittsburgh sleep quality index (PSQI) would be used to assess sleep quality.
Chonotype
Morningness-Eveningness questionnaire (MEQ) would be used to assess chronotype.
Circadian misalignment
Munich Chronotype Questionnaire (MCTQ) would be used to assess circadian misalignment.
Fatigue
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) would be used to assess fatigue.
Quality of life
Functional Assessment of Cancer Therapy-Breast (FACT-B) would be used to assess quality of life.
Beliefs about medicines
Beliefs about Medicines Questionnaire (BMQ) would be used to assess beliefs about medicines.
Illness perception
Brief Illness Perception Questionnaire (BIPQ) would be used to assess illness perception.
Social support
Multidimensional Scale of Perceived Social Support (MSPSS) would be used to assess social supports.
Body image
Body Image Scale (BIS) would be used to assess body image.
Resilience
Connor-Davidson Resilience Scale (CDRS) would be used to assess resilience.
Hormonal level
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
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.
Full Information
NCT ID
NCT02819921
First Posted
June 24, 2016
Last Updated
September 18, 2019
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital, Korea Cancer Center Hospital, Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT02819921
Brief Title
Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen
Official Title
Desvenlafaxine for the Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen: a Randomized, Double-blind, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in Recruiting Research Participants
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
June 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital, Korea Cancer Center Hospital, Pfizer
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Breast Neoplasms
Keywords
Hot Flashes, Breast Neoplasms, Tamoxifen, Desvenlafaxine Succinate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desvenlafaxine succinate 100mg
Arm Type
Experimental
Arm 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.
Arm Title
Desvenlafaxine succinate 50mg
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Desvenlafaxine succinate 100mg
Intervention Description
Pristiq 100mg
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine succinate 50mg
Intervention Description
Pristiq 50mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Reduction rate of hot flashes symptom score
Description
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.
Time Frame
From baseline to Week 5 (Intervention is started from Week 1)
Secondary Outcome Measure Information:
Title
Clinical impression state and change
Description
Clinical global impression (CGI) would be used to assess clinical impression state and change.
Time Frame
Week 1, Week 2, Week 5
Title
Peripheral neuropathy
Description
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.
Time Frame
Week 1, Week 2, Week 5
Title
Depression
Description
Patient health questionnaire (PHQ-9) would be used to assess mood status.
Time Frame
Baseline, Week 2, Week 5
Title
Anxiety
Description
Generalized anxiety disorder-7 (GAD-7) would be used to assess anxiety.
Time Frame
Baseline, Week 2, Week 5
Title
Manic or Hypomanic symptoms.
Description
Mood disorder questionnaire (MDQ) would be used to assess manic or hypomanic symptoms.
Time Frame
Baseline, Week 2, Week 5
Title
Sleep quality
Description
Pittsburgh sleep quality index (PSQI) would be used to assess sleep quality.
Time Frame
Baseline, Week 2, Week 5
Title
Chonotype
Description
Morningness-Eveningness questionnaire (MEQ) would be used to assess chronotype.
Time Frame
Baseline
Title
Circadian misalignment
Description
Munich Chronotype Questionnaire (MCTQ) would be used to assess circadian misalignment.
Time Frame
Baseline, Week 2, Week 5
Title
Fatigue
Description
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) would be used to assess fatigue.
Time Frame
Baseline, Week 2, Week 5
Title
Quality of life
Description
Functional Assessment of Cancer Therapy-Breast (FACT-B) would be used to assess quality of life.
Time Frame
Baseline, Week 2, Week 5
Title
Beliefs about medicines
Description
Beliefs about Medicines Questionnaire (BMQ) would be used to assess beliefs about medicines.
Time Frame
Baseline
Title
Illness perception
Description
Brief Illness Perception Questionnaire (BIPQ) would be used to assess illness perception.
Time Frame
Baseline
Title
Social support
Description
Multidimensional Scale of Perceived Social Support (MSPSS) would be used to assess social supports.
Time Frame
Baseline
Title
Body image
Description
Body Image Scale (BIS) would be used to assess body image.
Time Frame
Baseline
Title
Resilience
Description
Connor-Davidson Resilience Scale (CDRS) would be used to assess resilience.
Time Frame
Baseline
Title
Hormonal level
Description
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.
Time Frame
Week 2
Title
Genetic polymorphism
Description
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.
Time Frame
Week 2
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bong-Jin Hahm, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen
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