Clinical trial · Interventional
The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy
The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Wait-list Controlled Pilot Study
NCT03762694CI-TRIAL-00058044completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This pilot study is designed to determine whether acupuncture is a feasible, effective and safe method for alleviating insomnia among breast cancer patients undergoing chemotherapy as compared with a wait-list control.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Electroacupuncture (EA) and Auricular Acupuncture (AA)
- description
- 12 sessions acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization.
- interventionNames
- Device: Acupuncture
- type
- NO_INTERVENTION
- label
- Wait-list control
- description
- No treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as Acupuncture group.
Primary outcomes (1)
- measure
- Change in Insomnia Severity Index (ISI)
- timeFrame
- week 0, 3, 6 (primary outcome), 10, 14
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients between 18 and 75 years of age; 2. Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer; 3. Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months; 4. Insomnia onset after the diagnosis of breast cancer; 5. 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; 6. Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks; 7. Expected survival time of more than 6 months; 8. Ability to understand the nature of the study and willingness to give informed consent; 9. Ability to provide responses during outcome measurement. Exclusion Criteria: 1. Insomnia before the diagnosis of breast cancer; 2. Other sleep disorder (e.g., obstructive sleep apnoea); 3. Shift work or irregular sleep pattern; 4. Severe visual, hearing or language defects; 5. Severe hematological dysfunction (platelet count \<60,000/μL, haemoglobin \<8 g/dL or absolute neutrophil count \<1000/μL); 6. With pacemakers or other electronic implants that could interfere with electroacupuncture; 7. History of acupuncture use in the previous 3 months; 8. Participation in other clinical trials with intervention within 3 months of the beginning of the trial.
References
Publications (1)
- DERIVEDZhang J, Qin Z, So TH, Chen H, Lam WL, Yam LL, Yan Chan P, Lao L, Zhang ZJ. Electroacupuncture Plus Auricular Acupressure for Chemotherapy-Associated Insomnia in Breast Cancer Patients: A Pilot Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019103. doi: 10.1177/15347354211019103. PMID 34036813