Acupuncture for Sleep Disruption in Cancer Survivors

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Other: placebo; Procedure: acupuncture

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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	Other: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue reduction		1 month and 3 months post final acupuncture treatment
Quality of life in breast cancer survivors after acupuncture	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.	1 month and 6 months post final acupuncture treatment
Insomnia reduction		1 month and 3 months post final acupuncture treatment

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: July 2, 2010
• First Submitted That Met QC Criteria: July 12, 2010
• First Posted (Estimate): July 14, 2010

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: BRSADJ0020; 1P30AT005886-01 (U.S. NIH Grant/Contract); SU-04082010-5642 (Other Identifier: Stanford University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No