Acupuncture for Sleep Disruption in Cancer Survivors

Not Applicable

Completed

• Conditions: Breast Cancer; Sleep Initiation and Maintenance Disorders
• Interventions: Other: placebo; Procedure: acupuncture

• Registration Number: NCT01162018
• Lead Sponsor: Stanford University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-12
• Study First Posted: 2010-07-14
• Study Start: 2011-02
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Acupuncture	placebo	Sham Acupuncture
Acupuncture Arm	acupuncture	-

Primary Outcome Measures

Name	Time	Method
Fatigue reduction	1 month and 3 months post final acupuncture treatment
Insomnia reduction	1 month and 3 months post final acupuncture treatment
Quality of life in breast cancer survivors after acupuncture	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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States