Starting soon
Phase 3
Electroacupuncture for Cognitive Toxicity in Cancer Survivors: Assessing Implementation, Cost, and Effectiveness for Integration
Condition(s) studied
Cancer-related Cognitive Impairment
Investigational drug(s) / intervention(s)
True electroacupunctureSham electroacupuncture
True electroacupuncture: 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 electroacupuncture: 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 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)
Eligibility
Inclusion Criteria:
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
Exclusion Criteria:
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
Primary outcome measure(s)
- Objective cognitive function - multitasking — 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 — 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 — 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 — 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 — 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).
Trial sites (1)
| Facility | City | Region | Status |
| National Cancer Center Singapore |
Singapore |
Singapore |
|
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