Clinical trial NCT00094133: Hypnosis in Treating Hot Flashes in Breast Cancer Survivors
Official title: Hypnosis for Hot Flashes in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Cancer Survivor
Hot Flashes
Keywords: cancer survivor
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
breast cancer in situ
inflammatory breast cancer
hot flashes
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-10-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Hypnosis may be effective in decreasing hot flashes in breast cancer survivors.

PURPOSE: This randomized clinical trial is studying how well hypnosis works in treating hot flashes in breast cancer survivors.

Detailed description: OBJECTIVES:

* Determine the efficacy of hypnosis in controlling hot flashes in women who are breast cancer survivors.
* Determine the extent to which hypnotizability is related to the success of the hypnotherapy intervention.

OUTLINE: This is a randomized, controlled study. Patients are stratified according to age, gender, race, and educational background. All patients complete a Hot Flash Daily Diary to record frequency and severity of hot flashes for 1 week. Patients are then randomized to 1 of 2 treatment arms.

* Arm I (hypnotherapy): Patients undergo hypnotherapy once a week for 5 weeks. Patients complete the Hot Flash-Related Daily Interference Scale, the Hospital Depression and Anxiety Sub-scale, the CES Depression Scale, and the MOS-Sleep and Sexual Function Scales in week 5 after the last hypnotherapy intervention. Patients also complete another Hot Flash Daily Diary for 1 week in week 6 and are administered the Stanford Hypnotic Clinical Scale in week 7.
* Arm II (control): Patients receive no contact for 4 weeks. Patients complete the questionnaires as in arm I in week 5. Patients also complete another Hot Flash Daily Diary for 1 week in week 6 and are administered the Stanford Hypnotic Clinical Scale in week 7.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* History of primary breast cancer

  * No evidence of detectable disease
* At least 14 hot flashes per week for ≥ 1 month by self-reporting
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Life expectancy \> 6 months
* Menopausal status not specified
* Outpatient status
* No medical or psychiatric condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

* Concurrent antihormonal agents for breast cancer (e.g., tamoxifen or raloxifene) allowed provided the patient has been on them for ≥ 1 month
* No other concurrent hormonal therapy
* No other putative therapies for hot flashes ≥ 1 month prior to study entry

  * Concurrent vitamin E allowed
* No other concurrent treatment for hot flashes
* No concurrent cytotoxic chemotherapy
* Not concurrently using hypnosis for any reason

Primary outcomes:
measure: Hot flash control by Hot Flash Daily Diary in week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Temple
country: United States
facility: Scott and White Cancer Institute
state: Texas
Study officials:
affiliation: Scott and White Hospital & Clinic
name: Gary Elkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elkins G, Marcus J, Stearns V, Perfect M, Rajab MH, Ruud C, Palamara L, Keith T. Randomized trial of a hypnosis intervention for treatment of hot flashes among breast cancer survivors. J Clin Oncol. 2008 Nov 1;26(31):5022-6. doi: 10.1200/JCO.2008.16.6389. Epub 2008 Sep 22.