Hot FlashesNCT01000623
Venlafaxine and Hypnosis or Focused Attention in Treating Patients with Hot Flashes
A study testing venlafaxine, hypnotherapy and mind-body intervention procedure in people with Hot Flashes, run by Mayo Clinic at 1 site in United States.
Trial summary
Rationale: Venlafaxine may help relieve hot flashes in women who have had breast cancer. Hypnosis or focused attention may help control hot flashes in postmenopausal women. It is not yet known whether giving venlafaxine together with hypnosis or focused attention is more effective in treating hot flashes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes
- What is being tested?
- venlafaxine, hypnotherapy and mind-body intervention procedure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2010to 8 Sep 2015
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with a history of breast cancer (currently without malignant disease) or women who have no history of breast cancer but who wish to avoid estrogen due to a perceived increased risk of breast cancer
- Women over the age of 18 who are postmenopausal and wish to avoid hormonal therapy to treat menopausal symptoms
- Postmenopausal as defined by:
- no menstrual period in the past 12 months;
- no menstrual period in the past 6 months and an FSH level greater than 40; or
- women who have had a bilateral oophorectomy
Show all 23Show fewer
- If women have had a hysterectomy and still have their ovaries, they must meet the FSH criteria described above
- Note: We are excluding women of childbearing potential as this is a pilot trial and allowing women of childbearing potential with hot flashes to participate would introduce a hormonal heterogeneous population that would confound the ability to answer the research question
- Bothersome hot flashes (defined by their occurrence >= 28 times per week [about 4 per day]) and of sufficient severity to make the patient desire therapeutic intervention
- Presence of hot flashes for >=1 month prior to study entry
- Life expectancy >= 6 months
- ECOG Performance Status (PS) 0 or 1
- Possession of a CD/DVD player or ability to play a CD Exclusion
- Any of the following current (=< last 4 weeks) or planned therapies: antineoplastic chemotherapy, androgens, estrogens, progestational agents, other herbal supplements, including soy (herbal teas from a store are allowed), or Warfarin (1 mg of daily warfarin is allowed for central line patency)
- Tamoxifen, raloxifene, or aromatase inhibitors are allowed, but the patient must have been on a constant dose for >= 4 weeks and ust not be expected to stop the medication during the study period
- History of allergic or other adverse reaction to venlafaxine or SSRI's
- Current or planned use of other agents for treating hot flashes
- Use of venlafaxine or hypnosis in the past 6 months
- Diagnosis of/problems with chronic diarrhea or history of bowel obstruction or esophageal stricture
- Pregnant women or nursing women
- Current or planned use of any type of antidepressants
- Diagnosis of major depressive episode, acute anxiety disorder, liver or kidney dysfunction (defined by SGOT and creatinine levels 1.5 x upper limit of normal) as listed in the patient's medical history in the chart within the past year and by self report
- Uncontrolled hypertension (defined as 3 consecutive readings over the past year of over 160 systolic, and over 100 diastolic)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Biobehavioral Intervention for Hot Flashes
Rationale: Venlafaxine may help relieve hot flashes in women who have had breast cancer. Hypnosis or focused attention may help control hot flashes in postmenopausal women. It is not yet known whether giving venlafaxine together with hypnosis or focused attention is more effective in treating hot flashes.
Purpose: This randomized clinical trial is studying venlafaxine together with hypnosis or focused attention in treating patients with hot flashes.
Read the detailed description
Objectives:
- To evaluate the effect of hypnosis plus venlafaxine versus focused attention with venlafaxine versus hypnosis plus a placebo versus focused attention plus a placebo for reducing hot flashes.
II. To evaluate the side effects associated with hypnosis with venlafaxine versus focused attention with venlafaxine versus hypnosis plus a placebo versus focused attention plus a placebo for reducing hot flashes.
III. To evaluate the effects of the four treatment arms on mood, sleep, hot flash interference and menopause quality of life.
IV. To explore the role of expectancy and hypnotizability as moderators of the effect of each of the four treatment arms in reducing hot flashes.
Outline: Patients are randomized to 1 of 4 intervention arms. Patients receive oral venlafaxine or a placebo and practice hypnosis or focused attention.
- Conditions
- Hot Flashes
- Being tested
- venlafaxine, placebo, hypnotherapy, mind-body intervention procedure
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venlafaxineDrug
Also called Effexor, VNF
Given orally
placeboDrug
Also called PLCB
Given orally
hypnotherapyProcedure or surgery
Also called hypnosis
Practice hypnosis
mind-body intervention procedureProcedure or surgery
Also called mind-body interventions
Practice focused attention
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral venlafaxine once or twice daily in weeks 2-8. Patients see a therapist once a week to learn hypnosis in weeks 2-5. Patients continue hypnosis at home in weeks 6-8. Receives: Drug: venlafaxine; Procedure: hypnotherapy |
| Arm II | Active comparator | Patients receive oral venlafaxine once or twice daily in weeks 2-8. Patients see a therapist once a week to learn focused attention in weeks 2-5. Patients continue focused attention at home in weeks 6-8. Receives: Drug: venlafaxine; Procedure: mind-body intervention procedure |
| Arm III | Active comparator | Patients receive oral placebo once or twice daily in weeks 2-8. Patient see a therapist once a week to learn hypnosis in weeks 2-5. Patients continue hypnosis at home in weeks 6-8. Receives: Drug: placebo; Procedure: hypnotherapy |
| Arm IV | Active comparator | Patients receive oral placebo once or twice daily in weeks 2-8. Patient see a therapist once a week to learn focused attention in weeks 2-5. Patients continue focused attention at home in weeks 6-8. Receives: Drug: placebo; Procedure: mind-body intervention procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot flash score measured by hot flash diary data
Measured: Baseline
Hot flash severity measured by hot flash diary data
Measured: Baseline
Hot flash frequency measured by hot flash diary data
Measured: Baseline
Hot flash score measured by hot flash diary data
Measured: Daily during study, weeks 2-8
Hot flash severity measured by hot flash diary data
Measured: Daily during study, weeks 2-8
Hot flash frequency measured by hot flash diary data
Measured: Daily during study, weeks 2-8
Secondary outcomes (11)
Side effects measured by CTCAE v 3.0 and patient reports
Measured: Baseline
Side effects measured by CTCAE v 3.0 and patient reports
Measured: Once a week, weeks 2-8
Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire
Measured: Baseline
Mood measured by Profile of Mood States questionnaire
Measured: Baseline
Menopause quality of life measured by MENQOL questionnaire
Measured: Baseline
Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire
Measured: Baseline
Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire
Measured: Week 8
Mood measured by Profile of Mood States questionnaire
Measured: Week 8
Menopause quality of life measured by MENQOL questionnaire
Measured: Week 8
Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire
Measured: Week 8
Evaluate the moderating effect of the expectations for the intervention to be effective and the ability of the person to be hypnotized
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study start31 Jan 2010
- Primary completion28 Feb 2012
- Study completion8 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Debra L. Barton, R.N., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000623
- Sponsor's protocol ID
- MC09C7
- Other IDs
- NCI-2009-01303, 09-003233, MC09C7
- Status last verified
- Jan 2025
- First submitted
- 19 Oct 2009
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Biobehavioral Intervention for Hot Flashes
- ClinicalTrials.gov ID
- NCT01000623
- Acronym / sponsor ID
- MC09C7
- Conditions
- Hot Flashes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Jan 2010 (actual)
- Primary completion
- 28 Feb 2012 (actual)
- Study completion
- 8 Sep 2015 (actual)
- First posted
- 23 Oct 2009 (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.
Rationale: Venlafaxine may help relieve hot flashes in women who have had breast cancer. Hypnosis or focused attention may help control hot flashes in postmenopausal women. It is not yet known whether giving venlafaxine together with hypnosis or focused attention is more effective in treating hot flashes.
Purpose: This randomized clinical trial is studying venlafaxine together with hypnosis or focused attention in treating patients with hot flashes.
Detailed description
Objectives:
- To evaluate the effect of hypnosis plus venlafaxine versus focused attention with venlafaxine versus hypnosis plus a placebo versus focused attention plus a placebo for reducing hot flashes.
II. To evaluate the side effects associated with hypnosis with venlafaxine versus focused attention with venlafaxine versus hypnosis plus a placebo versus focused attention plus a placebo for reducing hot flashes.
III. To evaluate the effects of the four treatment arms on mood, sleep, hot flash interference and menopause quality of life.
IV. To explore the role of expectancy and hypnotizability as moderators of the effect of each of the four treatment arms in reducing hot flashes.
Outline: Patients are randomized to 1 of 4 intervention arms. Patients receive oral venlafaxine or a placebo and practice hypnosis or focused attention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: venlafaxine, Procedure: hypnotherapyPatients receive oral venlafaxine once or twice daily in weeks 2-8. Patients see a therapist once a week to learn hypnosis in weeks 2-5. Patients continue hypnosis at home in weeks 6-8. |
| Arm II | Active comparator | Drug: venlafaxine, Procedure: mind-body intervention procedurePatients receive oral venlafaxine once or twice daily in weeks 2-8. Patients see a therapist once a week to learn focused attention in weeks 2-5. Patients continue focused attention at home in weeks 6-8. |
| Arm III | Active comparator | Drug: placebo, Procedure: hypnotherapyPatients receive oral placebo once or twice daily in weeks 2-8. Patient see a therapist once a week to learn hypnosis in weeks 2-5. Patients continue hypnosis at home in weeks 6-8. |
| Arm IV | Active comparator | Drug: placebo, Procedure: mind-body intervention procedurePatients receive oral placebo once or twice daily in weeks 2-8. Patient see a therapist once a week to learn focused attention in weeks 2-5. Patients continue focused attention at home in weeks 6-8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Women with a history of breast cancer (currently without malignant disease) or women who have no history of breast cancer but who wish to avoid estrogen due to a perceived increased risk of breast cancer
- Women over the age of 18 who are postmenopausal and wish to avoid hormonal therapy to treat menopausal symptoms
- Postmenopausal as defined by:
- If women have had a hysterectomy and still have their ovaries, they must meet the FSH criteria described above
- Note: We are excluding women of childbearing potential as this is a pilot trial and allowing women of childbearing potential with hot flashes to participate would introduce a hormonal heterogeneous population that would confound the ability to answer the research question
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| venlafaxineAlso: Effexor, VNFGiven orally | Drug | Arm I, Arm II |
| placeboAlso: PLCBGiven orally | Drug | Arm III, Arm IV |
| hypnotherapyAlso: hypnosisPractice hypnosis | Procedure or surgery | Arm I, Arm III |
| mind-body intervention procedureAlso: mind-body interventionsPractice focused attention | Procedure or surgery | Arm II, Arm IV |
Primary outcome
Hot flash score measured by hot flash diary data
Time frame: Baseline
Hot flash severity measured by hot flash diary data
Time frame: Baseline
Hot flash frequency measured by hot flash diary data
Time frame: Baseline
Hot flash score measured by hot flash diary data
Time frame: Daily during study, weeks 2-8
Hot flash severity measured by hot flash diary data
Time frame: Daily during study, weeks 2-8
Hot flash frequency measured by hot flash diary data
Time frame: Daily during study, weeks 2-8
11 secondary outcomes
Side effects measured by CTCAE v 3.0 and patient reports
Time frame: Baseline
Side effects measured by CTCAE v 3.0 and patient reports
Time frame: Once a week, weeks 2-8
Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire
Time frame: Baseline
Mood measured by Profile of Mood States questionnaire
Time frame: Baseline
Menopause quality of life measured by MENQOL questionnaire
Time frame: Baseline
Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire
Time frame: Baseline
Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire
Time frame: Week 8
Mood measured by Profile of Mood States questionnaire
Time frame: Week 8
Menopause quality of life measured by MENQOL questionnaire
Time frame: Week 8
Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire
Time frame: Week 8
Evaluate the moderating effect of the expectations for the intervention to be effective and the ability of the person to be hypnotized
Time frame: Week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
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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.
Debra L. Barton, R.N., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing venlafaxine, hypnotherapy and mind-body intervention procedure in people with Hot Flashes, run by Mayo Clinic at 1 site in United States.
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 23 inclusion and 0 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: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hot flash score measured by hot flash diary data (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2025.