Sleep Initiation and Maintenance DisordersNCT01162018
Acupuncture for Sleep Disruption in Cancer Survivors
A study testing acupuncture in people with Sleep Initiation and Maintenance Disorders and Breast Cancer, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Breast Cancer
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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
- Being tested
- acupuncture, placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
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.
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Arm | Experimental | Not described Receives: Procedure: acupuncture |
| Sham Acupuncture | Sham comparator | Sham Acupuncture Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue reduction
Measured: 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.
Measured: 1 month and 6 months post final acupuncture treatment
Insomnia reduction
Measured: 1 month and 3 months post final acupuncture treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startFeb 2011
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, David Spiegel, Stanford University
- Investigators
- David Spiegel, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162018
- Sponsor's protocol ID
- BRSADJ0020
- Other IDs
- 1P30AT005886-01, SU-04082010-5642
- Status last verified
- Apr 2019
- First submitted
- 2 Jul 2010
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Sleep Disruption in Cancer Survivors
- ClinicalTrials.gov ID
- NCT01162018
- Acronym / sponsor ID
- BRSADJ0020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Feb 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 14 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Arm | Experimental | Procedure: acupuncture |
| Sham Acupuncture | Sham comparator | Other: placeboSham Acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureThe 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. | Procedure or surgery | Acupuncture Arm |
| placebo | Other | Sham Acupuncture |
Primary outcome
Fatigue reduction
Time frame: 1 month and 3 months post final acupuncture treatment
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.
Insomnia reduction
Time frame: 1 month and 3 months post final acupuncture treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Spiegel principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Sleep Initiation and Maintenance Disorders and Breast Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue reduction (time frame: 1 month and 3 months post final acupuncture treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.