Acupuncture for Sleep Disruption in Cancer Survivors

• ClinicalTrials.gov Identifier: NCT01162018
• Recruitment Status: Completed
• First Posted: July 14, 2010
• Last Update Posted: April 4, 2019
• Sponsor: Stanford University
• Collaborators: National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): David Spiegel, Stanford University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Sleep Initiation and Maintenance Disorders; Breast Cancer	Procedure: acupuncture; Other: placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Acupuncture Arm	Procedure: acupuncture; 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; Sham Acupuncture	Other: placebo

Outcome Measures

Primary Outcome Measures :

1. Fatigue reduction [ Time Frame: 1 month and 3 months post final acupuncture treatment ]
2. 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.
3. Insomnia reduction [ Time Frame: 1 month and 3 months post final acupuncture treatment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

National Institutes of Health (NIH)

National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: David Spiegel; Stanford University

More Information

• Responsible Party: David Spiegel, Jack, Samuel and Lulu Willson Professor in Medicine, Stanford University
• ClinicalTrials.gov Identifier: NCT01162018
• Other Study ID Numbers: BRSADJ0020; 1P30AT005886-01 ( U.S. NIH Grant/Contract ); SU-04082010-5642 ( Other Identifier: Stanford University )
• First Posted: July 14, 2010
• 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

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders