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Acupuncture for Sleep Disruption in Cancer Survivors
Not Recruiting
Trial ID: NCT01162018
Purpose
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 women would be randomized and stratified by sleep problems to two arms:
(Acupuncture Arm vs. Sham Acupuncture) with a goal of having 48 patients complete the study
(we anticipate about 20% attrition rate). The study interventions will begin after patients
completed their treatment. The placebo control for acupuncture will be a validated sham
acupuncture control Assessments will be made with daily diaries and with weekly
questionnaires. PSG data will be collected on the subsample of the population. Data will be
gathered via pencil-and-paper measures before, during, immediately following, one month
following the completion of treatment and six months after the conclusion of treatment. In
addition, actigraphy data (objective sleep continuity data) will be acquired prior to and
following treatment
Official Title
Acupuncture for Sleep Disruption in Cancer Survivors
Stanford Investigator(s)
David Spiegel
Jack, Lulu and Sam Willson Professor of Medicine
Rachel Manber, PhD
Professor of Psychiatry and Behavioral Sciences (General Psychiatry and Psychology-Adult)
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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.
Intervention(s):
procedure: acupuncture
other: placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
David Spiegel
6507236421