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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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

benton.tam.p.t@nccs.com.sg

Singapore1 site
  • National Cancer Center Singapore

    Singapore, 168583

    Yu KE, PhD, 66836174, ke.yu@nccs.com.sg

Other trials in Singapore

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.

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 groups in NCT07583979
Study groupRoleWhat they receive
True electroacupuncture armExperimentalEach participant will receive 10 electroacupuncture treatment sessions over the course of 10-12 weeks.
Receives: Device: True electroacupuncture
Sham electroacupuncture armSham comparatorEach 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 armNo interventionEach 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  1. First posted13 May 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion13 Jan 2029 (estimated)

Resources

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)
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 24716504
  • Wesevich 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 32146576
  • Cheung 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 22396443
  • Moreno 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 30048158
  • Yang 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 39260437
  • Dorland 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 28681478
  • Xie 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 36973688
  • Liu 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 32791039
  • Hwang 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 20622480
  • O'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 29426666
  • Hou 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 33204250
  • Jiang 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 35232269
  • Hou 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

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.

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