Hot FlashesPhase 4NCT02819921
Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen
A Phase 4 study testing Desvenlafaxine succinate 100mg and Desvenlafaxine succinate 50mg in people with Hot Flashes and Breast Neoplasms, run by Seoul National University Hospital at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Hot Flashes, Breast Neoplasms
- What is being tested?
- Desvenlafaxine succinate 100mg and Desvenlafaxine succinate 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 10 Nov 2017to 15 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Current daily tamoxifen use (≥ 6 days/week). Any planned surgery, adjuvant chemotherapy or radiation must have been completed.
- 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.
Who cannot join
- 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.
- Presense or past history of severe psychiatric symptoms such as hallucinations and delusions, manic episodes, or high suicide risk.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
About this study
Official title: Desvenlafaxine for the Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen: a Randomized, Double-blind, Placebo-controlled Study
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.
- Conditions
- Hot Flashes, Breast Neoplasms
- Being tested
- Desvenlafaxine succinate 100mg, Desvenlafaxine succinate 50mg, Placebo
- Keywords
- Hot Flashes, Breast Neoplasms, Tamoxifen, Desvenlafaxine Succinate
- Medical subject headings
- Hot Flashes, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desvenlafaxine succinate 100mgDrug
Pristiq 100mg
Desvenlafaxine succinate 50mgDrug
Pristiq 50mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Desvenlafaxine succinate 100mg | Experimental | 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. Receives: Drug: Desvenlafaxine succinate 100mg |
| Desvenlafaxine succinate 50mg | Experimental | 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. Receives: Drug: Desvenlafaxine succinate 50mg |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to Week 5 (Intervention is started from Week 1)
Secondary outcomes (17)
Clinical impression state and change
Clinical global impression (CGI) would be used to assess clinical impression state and change.
Measured: Week 1, Week 2, Week 5
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.
Measured: Week 1, Week 2, Week 5
Depression
Patient health questionnaire (PHQ-9) would be used to assess mood status.
Measured: Baseline, Week 2, Week 5
Anxiety
Generalized anxiety disorder-7 (GAD-7) would be used to assess anxiety.
Measured: Baseline, Week 2, Week 5
Manic or Hypomanic symptoms.
Mood disorder questionnaire (MDQ) would be used to assess manic or hypomanic symptoms.
Measured: Baseline, Week 2, Week 5
Sleep quality
Pittsburgh sleep quality index (PSQI) would be used to assess sleep quality.
Measured: Baseline, Week 2, Week 5
Chonotype
Morningness-Eveningness questionnaire (MEQ) would be used to assess chronotype.
Measured: Baseline
Circadian misalignment
Munich Chronotype Questionnaire (MCTQ) would be used to assess circadian misalignment.
Measured: Baseline, Week 2, Week 5
Fatigue
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) would be used to assess fatigue.
Measured: Baseline, Week 2, Week 5
Quality of life
Functional Assessment of Cancer Therapy-Breast (FACT-B) would be used to assess quality of life.
Measured: Baseline, Week 2, Week 5
Beliefs about medicines
Beliefs about Medicines Questionnaire (BMQ) would be used to assess beliefs about medicines.
Measured: Baseline
Illness perception
Brief Illness Perception Questionnaire (BIPQ) would be used to assess illness perception.
Measured: Baseline
Social support
Multidimensional Scale of Perceived Social Support (MSPSS) would be used to assess social supports.
Measured: Baseline
Body image
Body Image Scale (BIS) would be used to assess body image.
Measured: Baseline
Resilience
Connor-Davidson Resilience Scale (CDRS) would be used to assess resilience.
Measured: Baseline
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.
Measured: Week 2
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.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start10 Nov 2017
- Primary completion15 Mar 2019
- Study completion15 Jun 2019
Why it stopped: Difficulty in Recruiting Research Participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Korea Cancer Center Hospital, Pfizer
- Responsible party
- Sponsor
- Investigators
- Bong-Jin Hahm, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819921
- Sponsor's protocol ID
- WI209149
- Status last verified
- Sep 2019
- First submitted
- 24 Jun 2016
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39019875
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desvenlafaxine for the Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen: a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02819921
- Acronym / sponsor ID
- WI209149
- Conditions
- Hot Flashes, Breast Neoplasms
- Keywords
- Hot Flashes, Breast Neoplasms, Tamoxifen, Desvenlafaxine Succinate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in Recruiting Research Participants
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Korea Cancer Center Hospital, Pfizer
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Desvenlafaxine succinate 100mg | Experimental | Drug: Desvenlafaxine succinate 100mgTitration 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 | Experimental | Drug: Desvenlafaxine succinate 50mg50 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 comparator | Drug: Placebo50 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- Current daily tamoxifen use (≥ 6 days/week). Any planned surgery, adjuvant chemotherapy or radiation must have been completed.
- 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.
Key exclusion criteria (2 listed)
- 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.
- Presense or past history of severe psychiatric symptoms such as hallucinations and delusions, manic episodes, or high suicide risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desvenlafaxine succinate 100mgPristiq 100mg | Drug | Desvenlafaxine succinate 100mg |
| Desvenlafaxine succinate 50mgPristiq 50mg | Drug | Desvenlafaxine succinate 50mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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.
17 secondary outcomes
Clinical impression state and change
Time frame: Week 1, Week 2, Week 5
Peripheral neuropathy
Time frame: Week 1, Week 2, Week 5
Depression
Time frame: Baseline, Week 2, Week 5
Anxiety
Time frame: Baseline, Week 2, Week 5
Manic or Hypomanic symptoms.
Time frame: Baseline, Week 2, Week 5
Sleep quality
Time frame: Baseline, Week 2, Week 5
Chonotype
Time frame: Baseline
Circadian misalignment
Time frame: Baseline, Week 2, Week 5
Fatigue
Time frame: Baseline, Week 2, Week 5
Quality of life
Time frame: Baseline, Week 2, Week 5
Beliefs about medicines
Time frame: Baseline
Illness perception
Time frame: Baseline
Social support
Time frame: Baseline
Body image
Time frame: Baseline
Resilience
Time frame: Baseline
Hormonal level
Time frame: Week 2
Genetic polymorphism
Time frame: Week 2
Results and safety
The study was stopped early (reason given: Difficulty in Recruiting Research Participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Derived from this study: PubMed 39019875Kim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bong-Jin Hahm, M.D., Ph.D. principal investigator
Seoul National University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desvenlafaxine succinate 100mg and Desvenlafaxine succinate 50mg in people with Hot Flashes and Breast Neoplasms, run by Seoul National University Hospital at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty in Recruiting Research Participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction rate of hot flashes symptom score (time frame: From baseline to Week 5 (Intervention is started from Week 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02819921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.