Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 21, 2023
Open Peer Review Period: Oct 21, 2023 - Dec 16, 2023
Date Accepted: Jan 11, 2024
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The Role of Chinese Acupuncture for Chemotherapy Induced Cognitive Impairment in Elderly Cancer Patients: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Elderly cancer patients would suffer cognitive impairment due to chemotherapy, and a series of neurocognitive symptoms, known as "chemobrain". Those elderly populations have been disproportionately affected by chemobrain and heightened negative mental health outcomes after the cytotoxic chemical drug therapy.
Objective:
Chinese acupuncture is an emerging therapeutic option for chemotherapy induced cognitive impairment in elderly cancer patients, despite limited supporting evidence. By evaluating this novel Chinese medicine mode in elderly cancer patients at our institution, this study directly contributes to the existing knowledge in this area while establishing a basis for further research.
Methods:
The clinical trial is a 2-arm, prospective, randomized, blinded-assessor study with all cases of “chemobrain” related elderly cancer patients treated with Chinese acupuncture from Sep 30, 2023 to Dec 31, 2025. We will enroll 168 elderly cancer patients with clinically confirmed Chemobrain. Those participants will be recruited through screening by oncologists for Chinese acupuncture and evaluation. Electroacupuncture (EA) will be performed by registered practitioner of Chinese medicine. EA intervention will take about 45 minutes every time (2 sessions per week over 8 weeks). In the experiment group, acupuncture points are mainly in the head, limbs and abdomen, and a total of six pairs of electroacupuncture for head; while in the control group, acupuncture points are mainly on the head and limbs, only a pair of electro needles for head.
Results:
The Montreal Cognitive Assessment (MoCA) serves as the primary outcome. Digit span test will be the secondary outcome for attentional function and working memory. The quality of life(QOL) and multiple functional assessments will also be evaluated. Outcomes include MoCA, digit span test, QOL and multiple functional assessments at 2-, 4-, 6- and 8-weeks post randomization.
Conclusions:
Data from this efficacy trial will determine whether Chinese electroacupuncture successfully improves symptoms of chemobrain and whether these improvements could markedly reduce various side effects due to cytotoxic chemical drugs. If successful, findings from this study might have benefits in reducing chemotherapy-induced working memory impairment. Data from this study may be used to support an implementation and dissemination trial of Chinese electroacupuncture within real-world behavioral health and social service settings. Clinical Trial: ClinicalTrials.gov NCT05876988; https://clinicaltrials.gov/ct2/show/NCT05876988
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