NCT07583979

Brief 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. 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)

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P25-P50 for phase_3

Timeline
31mo left

Started Jul 2026

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2028

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2029

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

2.3 years

First QC Date

April 24, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

ElectroacupunctureAcupunctureTraditional Chinese MedicineCancer-related Cognitive ImpairmentCognitive ToxicityOncologySurvivor

Outcome Measures

Primary Outcomes (5)

  • 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).

    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).

    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).

    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).

    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).

    Baseline, 13 weeks after baseline, and 17 weeks after baseline.

Secondary Outcomes (14)

  • Subjective cognitive function

    Baseline, 13 weeks after baseline, and 17 weeks after baseline.

  • Fatigue

    Baseline, 13 weeks after baseline, and 17 weeks after baseline.

  • Symptom burden

    Baseline, 13 weeks after baseline, and 17 weeks after baseline.

  • Work productivity

    Baseline, 13 weeks after baseline, and 17 weeks after baseline.

  • Health utility

    Baseline, 13 weeks after baseline, and 17 weeks after baseline.

  • +9 more secondary outcomes

Study Arms (3)

True electroacupuncture arm

EXPERIMENTAL

Each participant will receive 10 electroacupuncture treatment sessions over the course of 10-12 weeks.

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.

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.

Interventions

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.

True electroacupuncture arm

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.

Sham electroacupuncture arm

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center Singapore

Singapore, 168583, Singapore

Location

Related Publications (31)

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MeSH Terms

Conditions

Neoplasms

Study Officials

  • Yu KE, PhD

    National Cancer Centre, Singapore

    STUDY CHAIR

Central Study Contacts

Benton PT TAM, MSc

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a randomized, sham- and waitlist-controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 13, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

January 13, 2029

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations