Cancer-related Cognitive ImpairmentPhase 3EAST-ALIGNNCT07583979
Electroacupuncture for Cognitive Toxicity in Cancer Survivors: Assessing Implementation, Cost, and Effectiveness for Integration
A Phase 3 study testing True electroacupuncture in people with Cancer-related Cognitive Impairment, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
The goal of this clinical trial is to evaluate the clinical effectiveness and understand the biological mechanisms of electroacupuncture (EA) in reducing cognitive toxicity among cancer survivors. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Cancer-related Cognitive Impairment
- What is being tested?
- True electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2026to 13 Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Survivor participants
- Aged 21-85 years
- Documented cancer diagnosis in electronic health records
- Perceived by the survivor or oncology care provider that cognitive function has worsened since cancer diagnosis and/or beginning of cancer treatment
- Able to understand English or Mandarin
- Able to provide informed consent
Show all 10Show fewer
- Stakeholder participants
- Aged ≥21 years
- Identified as having a relevant role, experience, or perspective relating to the delivery, referral, coordination, or implementation of EA or supportive cancer care in the study context
- Able to provide informed consent
Who cannot join
- Survivor participants
- Presence of brain metastases
- Severe needle phobia
- Known bleeding disorder (e.g. hemophilia, von Willebrand disease, thrombocytopenia).
- Current use of antiplatelet or anticoagulant therapy (e.g. aspirin, clopidogrel, warfarin, enoxaparin, rivaroxaban, dabigatran)
- Known blood-borne communicable disease (e.g. hepatitis B, hepatitis C, human immunodeficiency virus)
Show all 14Show fewer
- Presence of a pacemaker or other electronic implant, or a history of epilepsy
- Current acupuncture treatment or acupuncture received within the past 3 months
- Current pregnancy, planned pregnancy over the next 5 months, or breastfeeding.
- Incapable of providing informed consent
- Unable to complete study procedures
- Stakeholder participants
- Incapable of providing informed consent
- Unable to complete study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Benton PT TAM, MSc contact
Singapore1 site
National Cancer Center Singapore
Singapore, 168583
Yu KE, PhD, 66836174, ke.yu@nccs.com.sg
About this study
Official title: ElectroAcupuncture to Manage Symptoms of Cognitive Toxicity in Cancer Survivors: Assessing impLementation, Cost, and effectIveness for inteGratioN (EAST-ALIGN)
The goal of this clinical trial is to evaluate the clinical effectiveness and understand the biological mechanisms of electroacupuncture (EA) in reducing cognitive toxicity among cancer survivors. The study aims are:
- To evaluate the clinical effectiveness of a 10-week EA regimen targeting neuropsychiatric-related acupoints in reducing cognitive toxicity among cancer survivors in Singapore.
- To explore the biological mechanisms underlying EA's effects on cognitive function.
- To assess the early implementation of EA for managing cognitive toxicity in cancer survivors.
Read more
Researchers will compare results from the true EA arm, sham EA arm and waitlist control arm, to see if electroacupuncture can help improve cognitive issues related to cancer and its treatment, how it may work, and what factors may affect how it is delivered in cancer care.
Participants will:
- Be assigned to either of the 3 arms (true EA, sham EA, waitlist control)
- Received 10 EA sessions (if assigned to true or sham EA arm)
- Complete 3 study assessment visits at baseline, Week 13, and Week 17
- Be invited to a one-time interview to share their study experience (optional, if selected)
Read the detailed description
Electroacupuncture (EA) is a promising, emerging intervention to manage cognitive toxicity among patients with cancer. The primary goal of the EAST-ALIGN study is to evaluate the clinical effectiveness and understand the biological mechanisms of EA in reducing cognitive toxicity among cancer survivors through a randomized, blinded sham and waitlist controlled, clinical trial. Simultaneously, the investigators will collect implementation data on engaging community Traditional Chinese Medicine (TCM) practitioners to deliver EA. This approach facilitates the early identification and resolution of implementation barriers, accelerating EA adoption into clinical practice if proven effective.
- Conditions
- Cancer-related Cognitive Impairment
- Being tested
- True electroacupuncture, Sham electroacupuncture
- Keywords
- Electroacupuncture, Acupuncture, Traditional Chinese Medicine, Cancer-related Cognitive Impairment, Cognitive Toxicity, Oncology, Survivor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True electroacupunctureDevice
Electroacupuncture is administered at 13 predefined acupoints: Shenting (GV24), Baihui (DU20), Sishencong (EX-HN1), Zhongwan (CV12), Guanyuan (CV4), Neiguan (PC6, bilateral), Shenmen (HT7, bilateral), Zusanli (ST36, bilateral), Sanyinjiao (SP6, bilateral), Taixi (KI3, bilateral), Zhaohai (KI6, bilateral), Hegu (LI4, bilateral), and Taichong (LIV3, bilateral.
Sham electroacupunctureDevice
Electroacupuncture is administered at predefined non-disease related acupoints: Pianli (LI6) bilateral, Wenliu (LI7) bilateral, Futu (ST32) bilateral, Xiajuxu (ST39) bilateral, Daheng (SP15) bilateral, and Jiaosun (TE20) bilateral.
| Study group | Role | What they receive |
|---|---|---|
| True electroacupuncture arm | Experimental | Each participant will receive 10 electroacupuncture treatment sessions over the course of 10-12 weeks. Receives: Device: True electroacupuncture |
| Sham electroacupuncture arm | Sham comparator | Each participant will receive 10 sham electroacupuncture sessions designed to mimic treatment without therapeutic stimulation over the course of 10-12 weeks. Receives: Device: Sham electroacupuncture |
| Waitlist control arm | No intervention | Each participant will continue to receive usual care, but will not receive electroacupuncture or other acupuncture treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective cognitive function - multitasking
Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Multitasking Test, a computerized cognitive testing software. Score ranges from 0-160, with a lower score reflecting better performance. Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Multitasking Test).
Measured: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Objective cognitive function - learning and memory
Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Paired Associates Learning Test, a computerized cognitive testing software. Score ranges from 0-70, with a lower score reflecting better performance. Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Paired Associates Learning Test).
Measured: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Objective cognitive function - sustained attention
Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Rapid Visual Information Processing Test, a computerized cognitive testing software. Score ranges from 0-1, with a higher score reflecting better performance. Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Rapid Visual Information Processing Test).
Measured: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Objective cognitive function - response speed
Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Reaction Time Test, a computerized cognitive testing software. Score ranges from 100-5100 ms, with a lower score reflecting faster reaction time. Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Reaction Time Test).
Measured: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Objective cognitive function - working memory
Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Spatial Working Memory Test, a computerized cognitive testing software. Score ranges from 0-153, with a lower score reflecting better performance. Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Spatial Working Memory Test).
Measured: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Secondary outcomes (14)
Subjective cognitive function
The Functional Assessment of Cancer Therapy-Cognition (FACT-Cog) version 3 is a validated 37-item questionnaire assessing self-perceived subjective cognitive function. The total FACT-Cog score is summed from all items (range: 0-148), with higher scores indicating better subjective cognitive functioning.
Measured: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Fatigue
The Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) is a validated questionnaire that comprises 30 items and contains 5 subscales, each with 6 items: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor. The total MFSI-SF score is obtained by subtracting the vigor subscale from the sum of all items (range: 24-96), with a higher score indicating higher fatigue level.
Measured: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Symptom burden
The Rotterdam Symptom Checklist (RSCL) is a validated self-report measure of quality of life in patients with cancer. It includes 30 symptom items, 8 activity items, and 1 overall quality-of-life item. The symptom distress score combines the physical symptom distress scale (23 items, range 23-92) and, psychological distress scale (7 items, range 7-28), for a total range of 30-120. Higher scores indicate greater symptom burden, distress, or quality of life.
Measured: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Work productivity
The Work Productivity and Activity Impairment (WPAI) questionnaire is a patient-reported outcome measure that assesses the impact of health problems on work productivity and regular activities, including absenteeism, presenteeism, overall work impairment, and activity impairment. Scores in each of these four areas are expressed as a percentage from 0% to 100%, with higher scores indicating greater impairment and worse productivity.
Measured: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Health utility
EuroQOL Group 5-Dimension (EQ-5D-5L) contains a 5-item descriptive system measuring 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression; a visual analogue scale (VAS) measuring overall health status. EQ-5D Index Value (Utility Score) ranges from 0 to 1.0 with higher value indicating better health-related quality of life. The VAS ranges from 0 to 100, with higher scores reflecting better self-rated health.
Measured: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Biomarkers - plasma BDNF
Plasma brain-derived neurotropic factor levels at each time point will be analyzed from blood samples collected.
Measured: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Biomarkers - plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha)
Plasma concentrations of interleukin-1 beta (IL-1β), interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), and tumor necrosis factor-alpha (TNF-alpha) will be measured from blood samples. Each cytokine will be reported in picograms per milliliter (pg/mL). Higher values indicate higher plasma cytokine concentrations.
Measured: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Biomarkers - epigenetic ageing
Epigenetic ageing will be assessed using DNA methylation-based biological age metrics derived from blood samples.
Measured: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Safety assessment
Participants will be monitored for adverse events and the severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
Measured: 13 weeks after baseline and 17 weeks after baseline.
Implementation - acceptability of electroacupuncture treatment
Participants in the true and sham EA arms will complete a questionnaire evaluating their perceptions towards the true/sham EA treatment. Participants will be asked if they are satisfied and benefited from the treatment, and whether they would consider undergoing treatment again outside of a trial setting.
Measured: 13 weeks after baseline.
Implementation - adoption of EA
Adoption will be evaluated by tracking study enrollment logs, including the number of eligible individuals approached, the number recruited, and documented reasons for non-participation when available.
Measured: From commencement of study recruitment till the end of recruitment, assessed up to 3 years.
Implementation - treatment fidelity
Treatment fidelity will be assessed from standardized treatment logs for each true/sham EA session by the TCM practitioners. For blinding assessment, participants in the true and sham EA arms will be asked to guess their treatment arm allocation (True EA/ Sham EA/ Don't know).
Measured: 13 weeks after baseline.
Implementation - feasibility
Semi-structured interviews conducted using an interview guide developed based on the Consolidated Framework for Implementation Research (CFIR). Semi-structured interviews with key stakeholders (TCM practitioners, tertiary healthcare providers, clinical operations staff) to identify barriers and facilitators to integrating EA into routine oncology care.
Measured: 17 weeks after baseline, through study completion, estimated as up to 3 years.
Implementation - implementation cost
Implementation cost will be assessed using a time-driven activity-based costing approach. A structured activity log will be maintained by study personnel to document the time and resources required for each implementation activity, including personnel effort and fixed consumable resources.
Measured: From commencement of study recruitment, through study completion, estimated as up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion13 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Cancer-related Cognitive ImpairmentStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, sham- and waitlist-controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Thong Chai Medical Institution
- Responsible party
- Sponsor
- Investigators
- Yu KE, PhD, Study chair, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583979
- Sponsor's protocol ID
- 2026-0516
- Acronym
- EAST-ALIGN
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Janelsins MC, Kesler SR, Ahles TA, Morrow GR. Prevalence, mechanisms, and management of cancer-related cognitive impairment. Int Rev Psychiatry. 2014 Feb;26(1):102-13. doi: 10.3109/09540261.2013.864260.
PubMed 24716504Wesevich A, Johnson K, Altomare I: Cancer-Related Cognitive Impairment, 2021, pp 139-152
Cerulla Torrente N, Navarro Pastor JB, de la Osa Chaparro N. Systematic review of cognitive sequelae of non-central nervous system cancer and cancer therapy. J Cancer Surviv. 2020 Aug;14(4):464-482. doi: 10.1007/s11764-020-00870-2. Epub 2020 Mar 7.
PubMed 32146576Cheung YT, Shwe M, Tan YP, Fan G, Ng R, Chan A. Cognitive changes in multiethnic Asian breast cancer patients: a focus group study. Ann Oncol. 2012 Oct;23(10):2547-2552. doi: 10.1093/annonc/mds029. Epub 2012 Mar 6.
PubMed 22396443Moreno AM, Hamilton RA, Currier MB: Chapter 20 - Cancer-Related Cognitive Impairment: Diagnosis, Pathogenesis, and Management, in Cristian A (ed): Breast Cancer and Gynecologic Cancer Rehabilitation. St. Louis, Elsevier, 2021, pp 211-223
Bolton G, Isaacs A. Women's experiences of cancer-related cognitive impairment, its impact on daily life and care received for it following treatment for breast cancer. Psychol Health Med. 2018 Dec;23(10):1261-1274. doi: 10.1080/13548506.2018.1500023. Epub 2018 Jul 26.
PubMed 30048158Yang Y, Von Ah D. Cancer-related cognitive impairment: updates to treatment, the need for more evidence, and impact on quality of life-a narrative review. Ann Palliat Med. 2024 Sep;13(5):1265-1280. doi: 10.21037/apm-24-70. Epub 2024 Sep 9.
PubMed 39260437Dorland HF, Abma FI, Roelen CAM, Stewart RE, Amick BC, Ranchor AV, Bultmann U. Work functioning trajectories in cancer patients: Results from the longitudinal Work Life after Cancer (WOLICA) study. Int J Cancer. 2017 Nov 1;141(9):1751-1762. doi: 10.1002/ijc.30876. Epub 2017 Jul 19.
PubMed 28681478Xie L, Ng DQ, Heshmatipour M, Acharya M, Coluzzi P, Guerrero N, Lee S, Malik S, Parajuli R, Stark C, Tain R, Zabokrtsky K, Torno L, Chan A. Electroacupuncture for the management of symptom clusters in cancer patients and survivors (EAST). BMC Complement Med Ther. 2023 Mar 27;23(1):92. doi: 10.1186/s12906-023-03926-9.
PubMed 36973688Liu S, Wang ZF, Su YS, Ray RS, Jing XH, Wang YQ, Ma Q. Somatotopic Organization and Intensity Dependence in Driving Distinct NPY-Expressing Sympathetic Pathways by Electroacupuncture. Neuron. 2020 Nov 11;108(3):436-450.e7. doi: 10.1016/j.neuron.2020.07.015. Epub 2020 Aug 12.
PubMed 32791039Hwang IK, Chung JY, Yoo DY, Yi SS, Youn HY, Seong JK, Yoon YS. Effects of electroacupuncture at Zusanli and Baihui on brain-derived neurotrophic factor and cyclic AMP response element-binding protein in the hippocampal dentate gyrus. J Vet Med Sci. 2010 Nov;72(11):1431-6. doi: 10.1292/jvms.09-0527. Epub 2010 Jul 7.
PubMed 20622480O'Leary OF, Ogbonnaya ES, Felice D, Levone BR, C Conroy L, Fitzgerald P, Bravo JA, Forsythe P, Bienenstock J, Dinan TG, Cryan JF. The vagus nerve modulates BDNF expression and neurogenesis in the hippocampus. Eur Neuropsychopharmacol. 2018 Feb;28(2):307-316. doi: 10.1016/j.euroneuro.2017.12.004.
PubMed 29426666Hou Z, Qiu R, Wei Q, Liu Y, Wang M, Mei T, Zhang Y, Song L, Shao X, Shang H, Chen J, Sun Z. Electroacupuncture Improves Cognitive Function in Senescence-Accelerated P8 (SAMP8) Mice via the NLRP3/Caspase-1 Pathway. Neural Plast. 2020 Nov 4;2020:8853720. doi: 10.1155/2020/8853720. eCollection 2020.
PubMed 33204250Jiang J, Liu H, Wang Z, Tian H, Wang S, Yang J, Li Z. Effects of electroacupuncture on DNA methylation of the TREM2 gene in senescence-accelerated mouse prone 8 mice. Acupunct Med. 2022 Oct;40(5):463-469. doi: 10.1177/09645284221077103. Epub 2022 Mar 2.
PubMed 35232269Hou Z, Yang X, Li Y, Chen J, Shang H. Electroacupuncture Enhances Neuroplasticity by Regulating the Orexin A-Mediated cAMP/PKA/CREB Signaling Pathway in Senescence-Accelerated Mouse Prone 8 (SAMP8) Mice. Oxid Med Cell Longev. 2022 Feb 4;2022:8694462. doi: 10.1155/2022/8694462. eCollection 2022.
PubMed 35154573
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ElectroAcupuncture to Manage Symptoms of Cognitive Toxicity in Cancer Survivors: Assessing impLementation, Cost, and effectIveness for inteGratioN (EAST-ALIGN)
- ClinicalTrials.gov ID
- NCT07583979
- Acronym / sponsor ID
- EAST-ALIGN / 2026-0516
- Conditions
- Cancer-related Cognitive Impairment
- Keywords
- Electroacupuncture, Acupuncture, Traditional Chinese Medicine, Cancer-related Cognitive Impairment, Cognitive Toxicity, Oncology, Survivor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Singapore Thong Chai Medical Institution
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 13 Jan 2029 (estimated)
- First posted
- 13 May 2026 (actual)
- 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 goal of this clinical trial is to evaluate the clinical effectiveness and understand the biological mechanisms of electroacupuncture (EA) in reducing cognitive toxicity among cancer survivors. The study aims are:
- To evaluate the clinical effectiveness of a 10-week EA regimen targeting neuropsychiatric-related acupoints in reducing cognitive toxicity among cancer survivors in Singapore.
- To explore the biological mechanisms underlying EA's effects on cognitive function.
- To assess the early implementation of EA for managing cognitive toxicity in cancer survivors.
Researchers will compare results from the true EA arm, sham EA arm and waitlist control arm, to see if electroacupuncture can help improve cognitive issues related to cancer and its treatment, how it may work, and what factors may affect how it is delivered in cancer care.
Participants will:
- Be assigned to either of the 3 arms (true EA, sham EA, waitlist control)
- Received 10 EA sessions (if assigned to true or sham EA arm)
- Complete 3 study assessment visits at baseline, Week 13, and Week 17
- Be invited to a one-time interview to share their study experience (optional, if selected)
Detailed description
Electroacupuncture (EA) is a promising, emerging intervention to manage cognitive toxicity among patients with cancer. The primary goal of the EAST-ALIGN study is to evaluate the clinical effectiveness and understand the biological mechanisms of EA in reducing cognitive toxicity among cancer survivors through a randomized, blinded sham and waitlist controlled, clinical trial. Simultaneously, the investigators will collect implementation data on engaging community Traditional Chinese Medicine (TCM) practitioners to deliver EA. This approach facilitates the early identification and resolution of implementation barriers, accelerating EA adoption into clinical practice if proven effective.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized, sham- and waitlist-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| True electroacupuncture arm | Experimental | Device: True electroacupunctureEach participant will receive 10 electroacupuncture treatment sessions over the course of 10-12 weeks. |
| Sham electroacupuncture arm | Sham comparator | Device: Sham electroacupunctureEach participant will receive 10 sham electroacupuncture sessions designed to mimic treatment without therapeutic stimulation over the course of 10-12 weeks. |
| Waitlist control arm | No intervention | –Each participant will continue to receive usual care, but will not receive electroacupuncture or other acupuncture treatments. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Survivor participants
- Aged 21-85 years
- Documented cancer diagnosis in electronic health records
- Perceived by the survivor or oncology care provider that cognitive function has worsened since cancer diagnosis and/or beginning of cancer treatment
- Able to understand English or Mandarin
Key exclusion criteria (14 listed)
- Survivor participants
- Presence of brain metastases
- Severe needle phobia
- Known bleeding disorder (e.g. hemophilia, von Willebrand disease, thrombocytopenia).
- Current use of antiplatelet or anticoagulant therapy (e.g. aspirin, clopidogrel, warfarin, enoxaparin, rivaroxaban, dabigatran)
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 |
|---|---|---|
| True electroacupunctureElectroacupuncture is administered at 13 predefined acupoints: Shenting (GV24), Baihui (DU20), Sishencong (EX-HN1), Zhongwan (CV12), Guanyuan (CV4), Neiguan (PC6, bilateral), Shenmen (HT7, bilateral), Zusanli (ST36, bilateral), Sanyinjiao (SP6, bilateral), Taixi (KI3, bilateral), Zhaohai (KI6, bilateral), Hegu (LI4, bilateral), and Taichong (LIV3, bilateral. | Device | True electroacupuncture arm |
| Sham electroacupunctureElectroacupuncture is administered at predefined non-disease related acupoints: Pianli (LI6) bilateral, Wenliu (LI7) bilateral, Futu (ST32) bilateral, Xiajuxu (ST39) bilateral, Daheng (SP15) bilateral, and Jiaosun (TE20) bilateral. | Device | Sham electroacupuncture arm |
Primary outcome
Objective cognitive function - multitasking
Time frame: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Multitasking Test, a computerized cognitive testing software. Score ranges from 0-160, with a lower score reflecting better performance. Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Multitasking Test).
Objective cognitive function - learning and memory
Time frame: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Paired Associates Learning Test, a computerized cognitive testing software. Score ranges from 0-70, with a lower score reflecting better performance. Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Paired Associates Learning Test).
Objective cognitive function - sustained attention
Time frame: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Rapid Visual Information Processing Test, a computerized cognitive testing software. Score ranges from 0-1, with a higher score reflecting better performance. Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Rapid Visual Information Processing Test).
Objective cognitive function - response speed
Time frame: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Reaction Time Test, a computerized cognitive testing software. Score ranges from 100-5100 ms, with a lower score reflecting faster reaction time. Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Reaction Time Test).
Objective cognitive function - working memory
Time frame: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB®) Spatial Working Memory Test, a computerized cognitive testing software. Score ranges from 0-153, with a lower score reflecting better performance. Clinically significant improvement is defined as a Reliable Change Index (RCI) exceeding 1.96 from baseline in at least one out of five tests (including this Spatial Working Memory Test).
14 secondary outcomes
Subjective cognitive function
Time frame: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Fatigue
Time frame: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Symptom burden
Time frame: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Work productivity
Time frame: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Health utility
Time frame: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Biomarkers - plasma BDNF
Time frame: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Biomarkers - plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha)
Time frame: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Biomarkers - epigenetic ageing
Time frame: Baseline, 13 weeks after baseline, and 17 weeks after baseline.
Safety assessment
Time frame: 13 weeks after baseline and 17 weeks after baseline.
Implementation - acceptability of electroacupuncture treatment
Time frame: 13 weeks after baseline.
Implementation - adoption of EA
Time frame: From commencement of study recruitment till the end of recruitment, assessed up to 3 years.
Implementation - treatment fidelity
Time frame: 13 weeks after baseline.
Implementation - feasibility
Time frame: 17 weeks after baseline, through study completion, estimated as up to 3 years.
Implementation - implementation cost
Time frame: From commencement of study recruitment, through study completion, estimated as up to 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 24716504Janelsins MC, Kesler SR, Ahles TA, Morrow GR. Prevalence, mechanisms, and management of cancer-related cognitive impairment. Int Rev Psychiatry. 2014 Feb;26(1):102-13. doi: 10.3109/09540261.2013.864260.
- BackgroundWesevich A, Johnson K, Altomare I: Cancer-Related Cognitive Impairment, 2021, pp 139-152
- Background: PubMed 32146576Cerulla Torrente N, Navarro Pastor JB, de la Osa Chaparro N. Systematic review of cognitive sequelae of non-central nervous system cancer and cancer therapy. J Cancer Surviv. 2020 Aug;14(4):464-482. doi: 10.1007/s11764-020-00870-2. Epub 2020 Mar 7.
- Background: PubMed 22396443Cheung YT, Shwe M, Tan YP, Fan G, Ng R, Chan A. Cognitive changes in multiethnic Asian breast cancer patients: a focus group study. Ann Oncol. 2012 Oct;23(10):2547-2552. doi: 10.1093/annonc/mds029. Epub 2012 Mar 6.
- BackgroundMoreno AM, Hamilton RA, Currier MB: Chapter 20 - Cancer-Related Cognitive Impairment: Diagnosis, Pathogenesis, and Management, in Cristian A (ed): Breast Cancer and Gynecologic Cancer Rehabilitation. St. Louis, Elsevier, 2021, pp 211-223
- Background: PubMed 30048158Bolton G, Isaacs A. Women's experiences of cancer-related cognitive impairment, its impact on daily life and care received for it following treatment for breast cancer. Psychol Health Med. 2018 Dec;23(10):1261-1274. doi: 10.1080/13548506.2018.1500023. Epub 2018 Jul 26.
- Background: PubMed 39260437Yang Y, Von Ah D. Cancer-related cognitive impairment: updates to treatment, the need for more evidence, and impact on quality of life-a narrative review. Ann Palliat Med. 2024 Sep;13(5):1265-1280. doi: 10.21037/apm-24-70. Epub 2024 Sep 9.
- Background: PubMed 28681478Dorland HF, Abma FI, Roelen CAM, Stewart RE, Amick BC, Ranchor AV, Bultmann U. Work functioning trajectories in cancer patients: Results from the longitudinal Work Life after Cancer (WOLICA) study. Int J Cancer. 2017 Nov 1;141(9):1751-1762. doi: 10.1002/ijc.30876. Epub 2017 Jul 19.
- Background: PubMed 36973688Xie L, Ng DQ, Heshmatipour M, Acharya M, Coluzzi P, Guerrero N, Lee S, Malik S, Parajuli R, Stark C, Tain R, Zabokrtsky K, Torno L, Chan A. Electroacupuncture for the management of symptom clusters in cancer patients and survivors (EAST). BMC Complement Med Ther. 2023 Mar 27;23(1):92. doi: 10.1186/s12906-023-03926-9.
- Background: PubMed 32791039Liu S, Wang ZF, Su YS, Ray RS, Jing XH, Wang YQ, Ma Q. Somatotopic Organization and Intensity Dependence in Driving Distinct NPY-Expressing Sympathetic Pathways by Electroacupuncture. Neuron. 2020 Nov 11;108(3):436-450.e7. doi: 10.1016/j.neuron.2020.07.015. Epub 2020 Aug 12.
- Background: PubMed 20622480Hwang IK, Chung JY, Yoo DY, Yi SS, Youn HY, Seong JK, Yoon YS. Effects of electroacupuncture at Zusanli and Baihui on brain-derived neurotrophic factor and cyclic AMP response element-binding protein in the hippocampal dentate gyrus. J Vet Med Sci. 2010 Nov;72(11):1431-6. doi: 10.1292/jvms.09-0527. Epub 2010 Jul 7.
- Background: PubMed 29426666O'Leary OF, Ogbonnaya ES, Felice D, Levone BR, C Conroy L, Fitzgerald P, Bravo JA, Forsythe P, Bienenstock J, Dinan TG, Cryan JF. The vagus nerve modulates BDNF expression and neurogenesis in the hippocampus. Eur Neuropsychopharmacol. 2018 Feb;28(2):307-316. doi: 10.1016/j.euroneuro.2017.12.004.
- Individual participant dataSharing planned: No
Related trials for Cancer-related Cognitive Impairment
Recruiting
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Not yet recruiting
Photobiomodulation for Cancer-Related Cognitive Impairment
Cancer-related Cognitive Impairment
Not yet recruiting
Transcranial Direct Current Stimulation for Chemotherapy-Related Chronic Pain in Cancer Survivors
Chronic Pain, Neuropathic Pain
RecruitingObservational study
Older Breast Cancer Patients: Risk for Cognitive Decline
Cancer, Breast, Age-related Cognitive Decline
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.
Benton PT TAM, MSc contact
Yu KE, PhD study chair
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing True electroacupuncture in people with Cancer-related Cognitive Impairment, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 10 inclusion and 14 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: opening soon, as of the sponsor's last update on 13 May 2026. 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 Singapore. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu KE, PhD (+65 66836174, ke.yu@nccs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective cognitive function - multitasking (time frame: Baseline, 13 weeks after baseline, and 17 weeks after baseline.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07583979, which also lists 31 linked publications.
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 13 May 2026.