Clinical trial · Interventional
Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy
The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Sham-Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The proposed study is a randomized, parallel-group, placebo-controlled, subject- and assessor-blind trial. It is designed according to CONSORT and STRICTA recommendations. The 138 subjects will be randomly assigned to one of the two arms using block randomization in a 1:1 ratio: (I) acupuncture treatment, and (II) sham treatment. In groups (I) and (II), acupuncture or sham acupuncture treatment will be given twice a week for 6 weeks (12 sessions). A maintenance tapering treatment schedule will then be applied once per month for 3 months (3 sessions). The primary outcome will be improvement in sleep quality as measured by the change of ISI after 6 weeks of treatment. Secondary outcome assessment tools will include PSQI, HADS, BPI, BFI, FACT-B, sleep diaries, drug diaries, blinding success questionnaire and reports of adverse events. The subjects will be scheduled for on-site follow-up assessments at 3 and 6 months after the last treatment. An intention to treat (ITT) approach will be used for data analysis.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Chemotherapy | — | UNRESOLVED | — |
| Insomnia, Secondary | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electroacupuncture (EA) and Auricular Acupressure (AA) | Procedure | — | UNRESOLVED |
| Sham Electroacupuncture (SE) and Sham Auricular Acupressure (SA) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- True acupuncture group
- description
- 12 sessions of acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization, followed by once a month for 3 months, for a total of 15 sessions of treatments.
- interventionNames
- Procedure: Electroacupuncture (EA) and Auricular Acupressure (AA)
- type
- PLACEBO_COMPARATOR
- label
- Sham acupuncture group
- description
- 12 sessions of sham acupuncture treatment (SE+SA) will be given twice a week for 6 weeks after randomization, followed by once a month for 3 months, for a total of 15 sessions of treatments.
- interventionNames
- Procedure: Sham Electroacupuncture (SE) and Sham Auricular Acupressure (SA)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients between 18 and 75 years of age. * Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer. * Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months. * Insomnia onset after the diagnosis of breast cancer. * Insomnia occurs at least 3 nights per week, and presents for at least 1 month, with fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for brief insomnia disorder Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks. * Expected survival time of more than 6 months. * Ability to understand the nature of the study and willingness to give informed consent. * Ability to provide responses during outcome measurement. Exclusion Criteria: * Other sleep disorder (e.g., obstructive sleep apnoea). * Shift work or irregular sleep pattern. * Severe visual, hearing or language defects. * Severe hematological dysfunction (platelet count \<60,000/μL, haemoglobin \<8 g/dL or absolute neutrophil count \<1000/μL). * History of acupuncture use in the previous 3 months. * Participation in other clinical trials with intervention within 3 months of the beginning of the trial.
References
Publications (23)
- BACKGROUNDSavard J, Ivers H, Villa J, Caplette-Gingras A, Morin CM. Natural course of insomnia comorbid with cancer: an 18-month longitudinal study. J Clin Oncol. 2011 Sep 10;29(26):3580-6. doi: 10.1200/JCO.2010.33.2247. Epub 2011 Aug 8. PMID 21825267
- BACKGROUNDSavard J, Villa J, Ivers H, Simard S, Morin CM. Prevalence, natural course, and risk factors of insomnia comorbid with cancer over a 2-month period. J Clin Oncol. 2009 Nov 1;27(31):5233-9. doi: 10.1200/JCO.2008.21.6333. Epub 2009 Sep 8. PMID 19738124
- BACKGROUNDSavard J, Ivers H, Savard MH, Morin CM. Cancer treatments and their side effects are associated with aggravation of insomnia: Results of a longitudinal study. Cancer. 2015 May 15;121(10):1703-11. doi: 10.1002/cncr.29244. Epub 2015 Feb 11. PMID 25677509
- BACKGROUNDFakih R, Rahal M, Hilal L, Hamieh L, Dany M, Karam S, Shehab L, El Saghir NS, Tfayli A, Salem Z, Assi H, Temraz S, Shamseddine A, Mukherji D. Prevalence and Severity of Sleep Disturbances among Patients with Early Breast Cancer. Indian J Palliat Care. 2018 Jan-Mar;24(1):35-38. doi: 10.4103/IJPC.IJPC_137_17. PMID 29440804
- BACKGROUNDDahiya S, Ahluwalia MS, Walia HK. Sleep disturbances in cancer patients: underrecognized and undertreated. Cleve Clin J Med. 2013 Nov;80(11):722-32. doi: 10.3949/ccjm.80a.12170. PMID 24186891
- BACKGROUNDCash E, Sephton SE, Chagpar AB, Spiegel D, Rebholz WN, Zimmaro LA, Tillie JM, Dhabhar FS. Circadian disruption and biomarkers of tumor progression in breast cancer patients awaiting surgery. Brain Behav Immun. 2015 Aug;48:102-14. doi: 10.1016/j.bbi.2015.02.017. Epub 2015 Feb 26. PMID 25728235
- BACKGROUNDSavard J, Morin CM. Insomnia in the context of cancer: a review of a neglected problem. J Clin Oncol. 2001 Feb 1;19(3):895-908. doi: 10.1200/JCO.2001.19.3.895.