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Hypnosis for Hot Flashes in Breast Cancer Survivors - Article


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Menopause

Hot Flashes


Clinical Trial: Hypnosis for Hot Flashes in Breast Cancer Survivors

This study is currently recruiting patients.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

The purpose of this study is to determine whether hypnosis is effective in reducing hot flashes in breast cancer survivors. This study will also determine whether patients who can more easily be hypnotized will have less often and less severe hot flashes following hypnosis treatment.

Condition Treatment or Intervention
Breast Neoplasms
Hot Flashes
Menopause
 Behavior: Hypnosis

MedlinePlus related topics:  Breast Cancer;   Menopause
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  60

Study start: April 2004

Hot flashes are a significant problem for many breast cancer survivors, often resulting in disrupted sleep, anxiety, and decreased quality of life. Estrogen replacement therapy is standard treatment for hot flashes in women with no history of breast cancer. However, estrogens have been associated with increased risk of breast cancer, and therefore are not recommended for breast cancer survivors because of the increased risk of redeveloping breast cancer. Safe and effective interventions are needed to help breast cancer survivors who experience hot flashes. This study will evaluate the effectiveness of hypnosis in reducing the frequency and severity of hot flashes in breast cancer survivors.

Participants in this study will be randomly assigned to receive either five weekly sessions of hypnosis or no treatment. Participants will complete daily diaries detailing the frequency and severity of their hot flashes. Participants will be asked to complete weekly self-report questionnaires to monitor anxiety, depression, sleep quality, and sexual functioning.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • History of primary breast cancer without evidence of current detectable disease
  • Self-reported history of at least 14 hot flashes per week within 1 month prior to study entry
  • Life expectancy greater than 6 months
  • Able to attend weekly hypnosis sessions

Exclusion Criteria:

  • Current treatment for hot flashes
  • Current treatment with cytotoxic chemotherapy
  • Current hormonal therapy other than anti-hormonal agents for breast cancer
  • Use of anti-hormonal agents or other therapies for breast cancer within 1 month prior to study entry
  • Medical or psychiatric condition which may interfere with the study
  • Current treatment with hypnosis

Location and Contact Information


Texas
      Scott and White Clinic and Hospital, Temple,  Texas,  76508,  United States; Recruiting
Gary Elkins, PhD  254-724-2460    gelkins@swmail.sw.org 

Study chairs or principal investigators

Gary Elkins, PhD,  Principal Investigator,  Scott and White Clinic and Hospital   

More Information

Study ID Numbers:  CA100594-01A1
Record last reviewed:  October 2004
Last Updated:  October 14, 2004
Record first received:  October 14, 2004
ClinicalTrials.gov Identifier:  NCT00094133
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 11, 2008



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