Hypnosis in Treating Hot Flashes in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Hypnosis for Hot Flashes in Breast Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00094133
• Other study ID #: CDR0000481365
• Secondary ID: S-WHITE-8165
• Status: Recruiting
• Phase: N/A
• First received: October 14, 2004
• Last updated: September 19, 2013
• Start date: April 2006

Study information

• Verified date: September 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00324337

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer Survivor
• Hot Flashes

Intervention

Procedure:
• hot flashes attenuation

• hypnotherapy

Locations

Country	Name	City	State
United States	Scott and White Cancer Institute	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Scott and White Hospital & Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hot flash control by Hot Flash Daily Diary in week 6