Venlafaxine and Hypnosis or Focused Attention in Treating Patients with Hot Flashes
Evaluation of a Biobehavioral Intervention for Hot Flashes
3 other identifiers
interventional
71
1 country
1
Brief 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. Purpose: This randomized clinical trial is studying venlafaxine together with hypnosis or focused attention in treating patients with hot flashes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2009
CompletedFirst Posted
Study publicly available on registry
October 23, 2009
CompletedStudy Start
First participant enrolled
January 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2015
CompletedJanuary 8, 2025
January 1, 2025
2.1 years
October 19, 2009
January 6, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
Hot flash score measured by hot flash diary data
Baseline
Hot flash severity measured by hot flash diary data
Baseline
Hot flash frequency measured by hot flash diary data
Baseline
Hot flash score measured by hot flash diary data
Daily during study, weeks 2-8
Hot flash severity measured by hot flash diary data
Daily during study, weeks 2-8
Hot flash frequency measured by hot flash diary data
Daily during study, weeks 2-8
Secondary Outcomes (11)
Side effects measured by CTCAE v 3.0 and patient reports
Baseline
Side effects measured by CTCAE v 3.0 and patient reports
Once a week, weeks 2-8
Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire
Baseline
Mood measured by Profile of Mood States questionnaire
Baseline
Menopause quality of life measured by MENQOL questionnaire
Baseline
- +6 more secondary outcomes
Study Arms (4)
Arm I
EXPERIMENTALPatients 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 COMPARATORPatients 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 COMPARATORPatients 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 COMPARATORPatients 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.
Interventions
Practice focused attention
Eligibility Criteria
You may qualify if:
- 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
- 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
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Debra L. Barton, R.N., Ph.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2009
First Posted
October 23, 2009
Study Start
January 31, 2010
Primary Completion
February 28, 2012
Study Completion
September 8, 2015
Last Updated
January 8, 2025
Record last verified: 2025-01