Clinical trial · Interventional
Acupuncture Prevents Chemobrain in Breast Cancer Patients
An Assessor-Blinded, Randomised Controlled Trial of Acupuncture to Prevent Chemobrain in Breast Cancer Patients
- 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)
Chemobrain is an expression used to describe a cluster of chemotherapy-induced cognitive impairment symptoms, including problems with visual and verbal memory, forgetfulness, difficulty in learning, attention, concentration and coordination of multitasking and organization. Over 75% cancer patients experienced acute cognitive symptoms during chemotherapy and 17%-34% of them have long-term post-treatment cognitive deficits which can persist up to 10 years. Breast cancer survivors even display as high as 50%-75% prevalence of post-treatment cognitive impairment. Chemobrain has become an apparent quality-of-life issue for cancer survivors and will be encountered more frequently with the rise of the number of cancer survivors. There are no effective interventions available for preventing and treating chemobrain. Acupuncture is beneficial in reducing various side effects of anti-cancer treatment. It also shows the efficacy in improving mild cognitive impairment and other dementia disorders; facilitates the recovery of pathological microstructural changes of the brain. These results have led to the hypothesis that acupuncture is effective in preventing chemobrain and this preventive effect may be associated with the protection against cytokine production, epigenetic modification and microstructural changes of the brain. To test this hypothesis, an assessor-blinded, randomised controlled trial will be conducted to determine if a combination of DCEAS and body acupuncture could reduce the incidence and symptoms of chemobrain in breast cancer patients under chemotherapy compared to least acupuncture stimulation (LAS) as controls. A total of 168 breast cancer patients who are ready for chemotherapy will be randomly assigned to comprehensive acupuncture intervention (combined DCEAS and body acupuncture regimen + chemotherapy) (CAI) (n = 84) for 2 sessions per week for 8 weeks or least acupuncture stimulation (LAS) (minimal acupuncture + chemotherapy) (n = 84). All patients receive the standard chemotherapy of breast cancer. Treatment outcomes on cognitive performance, fatigue and the depression will be assessed.
Conditions
Conditions (4)
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemo-brain | — | UNRESOLVED | — |
| Drug-Related Side Effects and Adverse Reactions | — | UNRESOLVED | — |
| Mild Cognitive Impairment | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Body acupuncture | Procedure | — | UNRESOLVED |
| Cytoxan-containing chemotherapy regimens | Drug | — | UNRESOLVED |
| Dense cranial electroacupuncture stimulation | Procedure | — | UNRESOLVED |
| Least acupuncture stimulation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Comprehensive acupuncture (CAI)
- description
- Breast cancer patients receiving Cytoxan-containing chemotherapy regimens (Chemo) will receive Dense cranial electroacupuncture stimulation (DCEAS) and Body acupuncture (BA).
- interventionNames
- Procedure: Dense cranial electroacupuncture stimulation
- Procedure: Body acupuncture
- Drug: Cytoxan-containing chemotherapy regimens
- type
- SHAM_COMPARATOR
- label
- Least acupuncture stimulation (LAS)
- description
- Breast cancer patients receiving Cytoxan-containing chemotherapy regimens (Chemo) will receive Least acupuncture stimulation (LAS)
- interventionNames
- Procedure: Least acupuncture stimulation
- Drug: Cytoxan-containing chemotherapy regimens
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Chinese females aged 18 to 65 years; 2. have a diagnosis of stage I-IIIa breast cancer; and 3. are ready for orally administered or vein injection or both with Cytoxan-containing regimens as adjuvant chemotherapy before or after surgical treatment or in combination with other pharmacotherapy. Exclusion Criteria: 1. had chemotherapy in the last 2 years; 2. have cardiac pacemakers, epilepsy or other unstable medical conditions; 3. had investigational drug treatment within the past 6 months; 4. alcoholism or drug abuse within the past 1 year; or 5. have severe needle phobia.
References
Publications (40)
- BACKGROUNDNelson CJ, Nandy N, Roth AJ. Chemotherapy and cognitive deficits: mechanisms, findings, and potential interventions. Palliat Support Care. 2007 Sep;5(3):273-80. doi: 10.1017/s1478951507000442. PMID 17969831
- BACKGROUNDAsher A. Cognitive dysfunction among cancer survivors. Am J Phys Med Rehabil. 2011 May;90(5 Suppl 1):S16-26. doi: 10.1097/PHM.0b013e31820be463. PMID 21765260
- BACKGROUNDHede K. Chemobrain is real but may need new name. J Natl Cancer Inst. 2008 Feb 6;100(3):162-3, 169. doi: 10.1093/jnci/djn007. Epub 2008 Jan 29. No abstract available. PMID 18230787
- BACKGROUNDMatsuda T, Takayama T, Tashiro M, Nakamura Y, Ohashi Y, Shimozuma K. Mild cognitive impairment after adjuvant chemotherapy in breast cancer patients--evaluation of appropriate research design and methodology to measure symptoms. Breast Cancer. 2005;12(4):279-87. doi: 10.2325/jbcs.12.279. PMID 16286908
- BACKGROUNDAvisar A, River Y, Schiff E, Bar-Sela G, Steiner M, Ben-Arye E. Chemotherapy-related cognitive impairment: does integrating complementary medicine have something to add? Review of the literature. Breast Cancer Res Treat. 2012 Nov;136(1):1-7. doi: 10.1007/s10549-012-2211-5. Epub 2012 Aug 23. PMID 22915072
- BACKGROUNDBriones TL, Woods J. Chemotherapy-induced cognitive impairment is associated with decreases in cell proliferation and histone modifications. BMC Neurosci. 2011 Dec 9;12:124. doi: 10.1186/1471-2202-12-124. PMID 22152030
- BACKGROUNDSimo M, Rifa-Ros X, Rodriguez-Fornells A, Bruna J. Chemobrain: a systematic review of structural and functional neuroimaging studies. Neurosci Biobehav Rev. 2013 Sep;37(8):1311-21. doi: 10.1016/j.neubiorev.2013.04.015. Epub 2013 May 6. PMID 23660455