Acupuncture for Sleep Disruption in Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT01162018|
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : April 4, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Sleep Initiation and Maintenance Disorders Breast Cancer||Procedure: acupuncture Other: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acupuncture for Sleep Disruption in Cancer Survivors|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||August 2012|
|Experimental: Acupuncture Arm||
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. There are ten sessions each lasting approximately 20 minutes. All participants will have PSG data collected.
Sham Comparator: Sham Acupuncture
- Fatigue reduction [ Time Frame: 1 month and 3 months post final acupuncture treatment ]
- Quality of life in breast cancer survivors after acupuncture [ Time Frame: 1 month and 6 months post final acupuncture treatment ]Quality of life in breast cancer survivors after acupuncture will be measured through questionnaire using 28 item scale of functional assessment of chronic illness therapy- fatigue subscale (FACIT-F) version 4. Total score ranges from 0 to 108. A higher score indicates better quality of life.
- Insomnia reduction [ Time Frame: 1 month and 3 months post final acupuncture treatment ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162018
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||David Spiegel||Stanford University|
|Responsible Party:||David Spiegel, Jack, Samuel and Lulu Willson Professor in Medicine, Stanford University|
|Other Study ID Numbers:||
1P30AT005886-01 ( U.S. NIH Grant/Contract )
SU-04082010-5642 ( Other Identifier: Stanford University )
|First Posted:||July 14, 2010 Key Record Dates|
|Last Update Posted:||April 4, 2019|
|Last Verified:||April 2019|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases