Clinical trial NCT01162018: Acupuncture for Sleep Disruption in Cancer Survivors
Official title: Acupuncture for Sleep Disruption in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-07-14
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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


Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue reduction
timeFrame: 1 month and 3 months post final acupuncture treatment
measure: Quality of life in breast cancer survivors after acupuncture
timeFrame: 1 month and 6 months post final acupuncture treatment
measure: Insomnia reduction
timeFrame: 1 month and 3 months post final acupuncture treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: David Spiegel
role: PRINCIPAL_INVESTIGATOR
References: