Acupuncture for Sleep Disruption in Cancer Survivors

NCT ID: NCT01162018

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-08-31

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

Conditions

Sleep Initiation and Maintenance Disorders; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture Arm

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: PROCEDURE

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 Acupuncture

Sham Acupuncture

Group Type: SHAM_COMPARATOR

placebo

Intervention Type: OTHER

Interventions

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.

Intervention Type: PROCEDURE

placebo

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

David Spiegel

Jack, Samuel and Lulu Willson Professor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Spiegel

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

1P30AT005886-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SU-04082010-5642

Identifier Type: OTHER

Identifier Source: secondary_id

BRSADJ0020

Identifier Type: -

Identifier Source: org_study_id