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Status unknownNCT00094133Updated Sep 20, 2013

Hypnosis in Treating Hot Flashes in Breast Cancer Survivors

An interventional study of hot flashes attenuation and hypnotherapy in Breast Cancer, Cancer Survivor and Hot Flashes, sponsored by Scott and White Hospital & Clinic. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-20.

Sponsored by Scott and White Hospital & Clinic · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Sep 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 60 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Scott and White Hospital & Clinic is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Enrollment
60 participants (estimated)

Interventions

  • Procedurehot flashes attenuation
  • Procedurehypnotherapy
06

What researchers measure

Primary outcomes

  1. Hot flash control by Hot Flash Daily Diary in week 6

07

Study locations

1 of 1 sites recruiting
  • Scott and White Cancer Institute
    Temple, Texas 76508, United States
    • Clinical Trials Office - Scott and White Cancer Institute · Contact · 800-882-4366
    Recruiting
08

References and documents

Publications

  • 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. PubMed 18809612 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00094133
Lead sponsor
Scott and White Hospital & Clinic
Collaborators
National Cancer Institute (NCI)
First posted
Oct 15, 2004
Start date
Apr 2006
Last update
Sep 20, 2013

Study contacts

Gary Elkins, PhD
principal investigator · Scott and White Hospital & Clinic
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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