Hypnosis in Treating Hot Flashes in Breast Cancer Survivors

NCT00094133 | Unknown

• 2 other identifiers: CDR0000481365S-WHITE-8165
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Hot flash control by Hot Flash Daily Diary in week 6

Interventions

hot flashes attenuation PROCEDURE

hypnotherapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Scott and White Hospital & Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Scott and White Cancer Institute

Temple, Texas, 76508, United States

RECRUITING

Related 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. Epub 2008 Sep 22.

  PMID: 18809612 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes; Breast Carcinoma In Situ; Inflammatory Breast Neoplasms

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gary Elkins, PhD

  Scott and White Hospital & Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 14, 2004
• First Posted: October 15, 2004
• Study Start: April 1, 2006
• Last Updated: September 20, 2013

Record last verified: 2007-09

Locations

US (1)