Status:
COMPLETED
Acupuncture for Sleep Disruption in Cancer Survivors
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Sleep Initiation and Maintenance Disorders
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The proposed study will recruit 60 women with breast cancer who finished undergoing treatment who complain of persistent insomnia problems that began with onset of their cancer diagnosis. The eligible...
Eligibility Criteria
Inclusion
- Females diagnosed with breast cancer who are not currently undergoing cancer treatment (hormonal treatment is permitted).
- The last cancer treatment ≥ 2 weeks prior to screening.
- ≥ 21 years of age.
- Able to understand written and spoken English.
- Have a habitual bedtime between 9:00 pm and 3:00 am and a habitual rise time between 4:00 am and 11 am.
- Meet DSM-IV criteria for insomnia (determined by the of the Duke Structured Interview of Sleep Disorders) with duration ≥ 1 month by Screening.
- Willingness to discontinue the use of any current sleep aides (prescription, OTC, or naturopathic agents).
- Properly executed Informed Consent.
- Karnofsky Performance Scale Index score ≥ to 70, (patients who score between 61-69 might be included per PI's evaluation).
- Insomnia Severity Index (ISI) \> 8 at Screening.
- Able to travel to Stanford University and vicinity for assessments and acupuncture treatments.
Exclusion
- Unstable medical or psychiatric illness (eMINI, current or within the last 5 years).
- Exposure to acupuncture within 6 months prior to screening.
- Currently pregnant or nursing.
- History of substance abuse or meet criteria for current alcohol abuse or dependence.
- Center for Epidemiological Studies Depression Scale (CES-D) \>27 at Screening. Meet criteria for sleep apnea, restless legs syndrome or Circadian Rhythm Sleep Disorder on the basis of the Duke Structured Interview of Sleep Disorders (DSISD) or STOP-BANG is ≥ to 3.
- Major surgery within 4 weeks prior to first acupuncture treatment.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01162018
Start Date
February 1 2011
End Date
August 1 2012
Last Update
April 4 2019
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305