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OpenTrials
Completed

NCT Number: NCT01162018

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

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Breast Cancer Breast Diseases Breast Neoplasms Dyssomnias Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

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.

Placebo

Other

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 14, 2010
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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