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Acupuncture for Sleep Disruption in Cancer Survivors

Primary Purpose

Sleep Initiation and Maintenance Disorders, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acupuncture
placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupuncture Arm

Sham Acupuncture

Arm Description

Sham Acupuncture

Outcomes

Primary Outcome Measures

Fatigue reduction
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.
Insomnia reduction

Secondary Outcome Measures

Full Information

First Posted
July 2, 2010
Last Updated
April 2, 2019
Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01162018
Brief Title
Acupuncture for Sleep Disruption in Cancer Survivors
Official Title
Acupuncture for Sleep Disruption in Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders, Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture Arm
Arm Type
Experimental
Arm Title
Sham Acupuncture
Arm Type
Sham Comparator
Arm Description
Sham Acupuncture
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
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
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Fatigue reduction
Time Frame
1 month and 3 months post final acupuncture treatment
Title
Quality of life in breast cancer survivors after acupuncture
Description
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.
Time Frame
1 month and 6 months post final acupuncture treatment
Title
Insomnia reduction
Time Frame
1 month and 3 months post final acupuncture treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Spiegel
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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Acupuncture for Sleep Disruption in Cancer Survivors

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