Trends in clinical trials of acupuncture for chemotherapy-related cognitive impairment: A Scoping Review

Mikyung Kim; Chang-ho Han; Kim, Mikyung; Han, Chang-ho

doi:10.13048/jkm.25013

JKM > Volume 46(1); 2025 > Article

Kim and Han: Trends in clinical trials of acupuncture for chemotherapy-related cognitive impairment: A Scoping Review

Review Article

The Journal of Korean Medicine 2025; 46(1): 181-204.

Published online: March 01, 2025

DOI: https://doi.org/10.13048/jkm.25013

Trends in clinical trials of acupuncture for chemotherapy-related cognitive impairment: A Scoping Review

Mikyung Kim¹^{, *}

, Chang-ho Han²

¹Department of Internal Medicine, Dongguk University Ilsan Oriental Hospital

²Department of Internal Medicine, College of Korean Medicine, Dongguk University WISE Campus

Correspondence to: Mikyung Kim, Dongguk University Ilsan Oriental Hospital, 27, Dongguk-ro Ilsandong-gu, Goyang-si, Gyeonggi-do, 10326, Tel: +82-31-961-9045, E-mail: 01mkkim@gmail.com

Received January 19, 2025 Revised February 17, 2025 Accepted February 17, 2025

Abstract

Objectives

This study was aimed to review and analyze trends in clinical trials of acupuncture for chemotherapy-related cognitive impairment (CRCI).

Methods

On December 20, 2024, three core databases (PubMed, Embase, and Cochrane Library), the International Clinical Trials Registry Platform, and ClinicalTrials.gov were searched to obtain clinical trial reports and protocols that evaluated the effects of acupuncture on cognitive function in patients with CRCI.

Results

A total of five reports and six protocols were retrieved. All five reports were conducted in East Asia, including China, Hong Kong, and Korea, and only two of them were randomized controlled trials (RCTs). These studies suggest that acupuncture may be beneficial in improving CRCI. All protocols were RCTs, and were scheduled to be conducted in China, Italy, and the United States. Most of them planned to conduct cognitive function tests but also measure biomarkers.

Conclusion

Only a few small trials have been published so far, even though they claimed results supporting the benefit of acupuncture. Current RCTs that are ongoing or planned to be conducted tend to be larger in scale and more diverse in quality compared to previous trials. Therefore, it is expected that we will soon be able to secure the evidence necessary to draw more definitive conclusions about the effect of acupuncture on CRCI. However, future trials need to be carefully designed to complement the limitations of existing reports and protocols.

Keywords: chemotherapy-related cognitive impairment, chemotherapy-induced cognitive impairment, chemobrain, chemofog, acupuncture, review

Fig 1

Flow diagram of literature search

Table 1-1

Characteristics of previously published clinical studies on the effect of acupuncture for chemotherapy-related cognitive impairment

Study id	Study method	Presentation type	Location country	Settings	Study period	Restrictions for selecting participants						Study design	No. of participants
Study id	Study method	Presentation type	Location country	Settings	Study period	Age	Gender	Nationality	Cancer type	Anticancer Tx	Cog. imp. criteria	Study design	registered	completed
Tong18 [18]	RCT	Academic journal	Mainland China	University Hospital	May–Oct 2017	21–55*	Female	NR	Br (0–III)	Under adj CTx	Subjective	2-arm, acu vs nonacu	40 vs 40	39 vs 36
Zeng18 [19]	Prospective pilot cohort	Academic journal	Mainland China & HK	University Hospital	NR	18–65	Female	Chinese	Gyn (I–III)	Under adj CTx	Objective	2-arm, acu vs nonacu	3 vs 3	3 vs 3
Zhang20 [20]	RCT	Academic journal	HK	University Hospital	Oct 2015–Dec 2018	18–65	Female	Chinese	Br (I–IIIa)	Under adj CTx or recently completed	Objective†	2-arm, EA vs mini EA	46 vs 47	40 vs 43
Lyu22 [21]	Prospective pre-post	Academic journal	Republic of Korea	University Hospital	Nov 2016–Jan 2018	19–75	No	NR	Solid cancer	Completion of anticancer Tx > 6 mn	Subjective	1-arm, pre-post EA	12	10
Lv23 [22]	Retrospective chart review	Conference abstract	Mainland China	NR	2019–2022	NR (the Elderly)	NR	NR	NR	CTx	Clinically confirmed	2-arm, EA+HD vs CM	83 vs 85	83 vs 85

RCT, randomized controlled trial; HK, Hong Kong; NR, not reported; Br, breast cancer; Gyn, gynecological cancer; Tx, treatment; adj., adjuvant; CTx, chemotherapy; cog. imp.: cognitive impairment; mn, months; acu, acupuncture; mini, minimal; EA, electroacupuncture; HD, herbal decoction; CM, conventional medicine

* premenopausal

† Since this study assessed the preventive effect for chemobrain, it is an outcome measure, not a selection criteria.

Table 1-2

Details of interventions conducted in previously published clinical studies on the effect of acupuncture for chemotherapy-related cognitive impairment

Study id	Tx int.								Control int.
Study id	Tx period	Freq/wk	Session	Acu dur	Size (mm)	Depth (mm)	EA freq.	Acupoints	Control int.
Tong18 [18]	8 wk	5	40	30 min	0.25x25,40	10–35	NA	GV20, GB24, EX-1, ST36, KI3, KI4, GB39	No Acu
Zeng18 [19]	4–6 wk	2	10	30 min	0.25x40	25–40	NA	GV20, EX-HN1, EX-HN3, EX-HN5, GB8, GB15, ST8	No Acu
Zhang20 [20]	8 wk	2	16	30 min	0.30x25,40	10–30	2 Hz	GV26, HT7, LI4, TE5, ST36, ST40, SP6, CV4, CV12	Mini EA
Lyu22 [21]	8 wk	2	16	30 min	0.25x30	PD	2 Hz	GV20, GV24, EX-HN1, GB20, HT7, PC6, KI3	NA
Lv23 [22]	8 wk	2	16	NR	NR	NR	NR	NR	CM

Tx, treatment; int., intervention; wk, week; freq, frequency; session, number of acu session; acu, acupuncture; dur, duration; min, minute; NR, not reported; size, acupuncture needle size; depth; depth of acupuncture needling; PD; at practitioner’s decision; EA, electroacupuncture; NA, not applicable; Auri, auriculoacupuncture; Mini, minimal; NA, not applicable; CM, conventional medicine

Table 1-3

Outcome measures used in previously published clinical studies on the effect of acupuncture for chemotherapy-related cognitive impairment

Study id	Time points (wk)	Outcome measures									Results
		Cognitive function-related outcomes				Others
		Subjective	Objective	Biomarkers	Brain imaging	QOL	Function	Emotion	CTx. Tox	Safety
Tong18 [18]	0, 8	FACT-Cog v3	AVLT, VFT, SDMT, CDT, TMT-B	sBDNF							FACT-Cog & AVLT-3 (recognition), CDT, sBDNF: only acu gr showed sig. imp.
Zeng18 [19]	0, 4–6		AVLT, TMT-A&B, WAIS-III DST, COWA		Brain MRI (DTI & MRS)						All cognitive scores: acu gr > con gr Brain imaging: better preservation of WM integrity in lt hippo in acu gr.
Zhang20 [20]	0,2,4,6,8		MoCA, f&rDST, chemobrain prevalence			EORTC QLQ-C30 & Br23			CTx,-related AEs		Only in rDST: EA gr showed sig. imp. over the con gr. MoCA, fDST, chemobrain prevalence (MoCA<26): not sig. dif. btw grs. Diarrhea, tenseness, worrisome, irritation, headache, tinnitus: EA gr. < con gr.
Lyu22 [21]	0,4,8,12	FACT-Cog v3	MoCA, SNSB			EORTC QLQ-C30		HADS		VS, BT, AE	PCI subscale of FACT-Cog, MoCA: sig. imp. Subsccales for language & related function and memory in SNSB: sig. imp. FACT-Cog total score & QOL: imp. but not statistically different. Emotional scale: stay stable No SAE.
Lv23 [22]	0,2,8		MoCA, DST			QoL	ECOG				rDST: acu gr showed sig. imp. over the con gr Total score of MoCA & chemobrain prevalence: not sig. different btw grs. Functional scale imp.: acu gr > con gr.

Wk, week; FACT-Cog, functional assessment of cancer treatment cognition; v3, version 3; AVLT, auditory-verbal learning test; VFT, verbal fluency test; SDMT, symbol digit modality test; CDT, clock-drawing test; TBT, trail-making test; WAIS, Wechsler adult intelligence scale; DST, digit span test; COWA, controlled oral word association test; MoCA, Montreal cognitive assessment; f&r, forward and reverse; SNSB, Seoul neuropsychological screening battery; sBDNR, serum blood-derived neurotrophic factor; MRI, magnetic resonance imaging; DTI, diffusion tensor imaging; MRS, magnetic resonance spectroscopy; QOL, quality of life; EORTC QLQ-C30, European organization for research and treatment of cancer quality of life questionnaire core 30; BR, breast cancer; ECOG, Eastern cooperation oncology group performance status; HADS, hospital anxiety and depression scale; Tox, toxicity; AE, adverse event; VS, vital signs; BT, blood test; acu, acupuncture; gr, group; sig, significant; imp, improvement; con, control; WM, white matter; lt, left; hippo, hippocampus; dif., difference; btw, between; PCI, perceived cognitive impairment; SAE, serious AE

* Statistical significance: P < 0.05

Table 2

Acupoints used in the previously published and of yet-to-be-published clinical studies on the effect of acupuncture for chemotherapy-related cognitive impairment

Body parts	Acupoints	Number of clinical studies using the acupoint

		Previously published studies (n=4)	Yet-to-be-published studies (n=4)
Head and neck	GV20 (Baihui, 百會)	4	4
	EX-HN1 (Sishencong, 四神聰)	4	2
	GV24 (Shenting, 神庭)	2	1
	EX-HN3 (Yintang, 印堂)	2	3
	GB20 (Fengchi, 風池)	2	0
	EX-HN5 (Taiyang, 太陽)	2	1
	GB8 (Shuaigu, 率谷)	2	0
	GB15 (Toulinqi, 頭臨泣)	2	1
	GV26 (Shougou, 水溝)	1	0
	ST8 (Touwei, 頭維)	1	0

Trunk	CV12 (Zhongwan, 中脘)	1	2
	CV4 (Guanyuan, 關元)	1	2
	CV17 (Danzhong, 膻中)	0	1
	CV6 (Qihai, 氣海)	0	1

Upper limbs	HT7 (Shenmen, 神門)	2	3
	LI4 (Hegu, 合谷)	1	2
	TE5 (Waiguan, 外關)	1	1
	PC6 (Neiguan, 內關)	1	1

Lower limbs	ST36 (Zusanli, 足三里)	2	3
	SP6 (Sanyinjiao, 三陰交)	1	2
	KI3 (Taixi, 太谿)	1	3
	KI4 (Dazhong, 大鐘)	1	0
	GB39 (Xuanzhong, 懸鍾)	1	0
	ST40 (Fenglong, 豊隆)	1	1
	LR3 (Taichong, 太衝)	1	1
	KI6 (Zhaohai, 照海)	0	1

Auricular points	Shenmen, 神門	0	1
Auricular points	No specific points mentioned	0	1

Table 3-1

Characteristics of yet-to-be-published clinical studies on the effect of acupuncture for chemotherapy-related cognitive impairment

Study id	Study method	Presentation type	Location country	Settings	Study period	Restrictions for selecting participants						Study design	No. of participants
Study id	Study method	Presentation type	Location country	Settings	Study period	Age	Gender	Nationality	Cancer type	Anticancer Tx	Cog. imp. criteria	Study design	No. of participants
Rossi20 [23]	RCT	Conference abstract	Italy	Homeopathi c clinic of Regional Hospital	NR	18–70	F	NR	Br (I–IIIa)	Adj. CTx and/or Endo Tx.	NR	3-arm, Acu/auri+R/D vs Homeo+R/D vs R/D	100 vs 100 vs 100
Rossi24 [24]	RCT	Conference abstract	Italy	Regional Integrative Medicine center	Feb 2021-NR	18–65	NR	NR	Br* (I–IIIa)	Adj. CTx and/or Endo Tx.	NR	4-arm, Acu/auri +Homeo+R/D vs Acu/auri+R/D vs Homeo+R/D vs R/D	Total 320
Gao24 [25]	RCT	Clinical trial registry	Mainland China	University Hospital	Jan 2024–Apr 2025	18–65	NR	NR	Triple negative Br + TCM PI†	CTx	MCI within 3 yrs after CTx.	2-arm, acu§ vs mini acu	25 vs 25
Xie23 [26]	RCT	Academic journal	United States of America	University &Regional Hospital	Apr 2022–Dec 2025	≥ 16	No	NR	NR	Have received anticancer Tx.	Including subjective Cog. imp‡	2-arm, EA vs mini EA	32 vs 32
Yan23 [27]	RCT	Clinical trial registry	Mainland China	NR	Aug 2023–Dec 2024	18–75	NR	NR	Br (I–III)	Scheduled to undergo CTx.	Cog. test score at or below 1.5 SDs	2-arm, EA vs mini EA	Total 100
Zhao24 [28]	RCT	Academic journal	Mainland China	University Hospital	Sep 2023–Dec 2025	≥ 60	NR	NR	No	Under or scheduled to undergo CTx.	Cog. test score at or below 1.5 SDs	2-arm, EA vs mini EA	Total 168

RCT, randomized controlled trial; NR, not reported; F, female; Br, breast cancer; TCM, traditional Chinese medicine; PI, pattern identification (辨證), Tx, treatment; Adj, adjuvant; CTx, chemotherapy; Endo, endocrine; cog., cognitive; imp., impairment; MCI, mild cognitive impairment; yrs, year; SD, standard deviation; acu, acupuncture; auri, auricular acupuncture; Homeo, homeopathy; R/D, rehabilitation exercises and diet; mini, minimal; EA, electroacupuncture.

* Br cancer diagnosed within 12 months.

† Patients identified as having a “disturbance of qi and blood (氣血失調)” pattern in diagnosis based on traditional Chinese medicine theory.

‡ Those who experienced two of the following symptoms for more than 7 days: cancer-related memory impairment/attention deficit, fatigue, insomnia, depression, and anxiety were included in the study participants.

§ Reconciling qi and blood & tonifying heart and mind method.

Table 3-2

Details of interventions conducted in yet-to-be-published clinical studies on the effect of acupuncture for chemotherapy-related cognitive impairment

Study id	Tx int.								Control int.
Study id	Tx period	Freq/wk	Session	Acu dur	Size (mm)	Depth (mm)	EA freq.	Acupoints	Control int.
Rossi20 [23]	12 wk	1	12	NR	NR	NR	NA	GV20, EX-HN1, KI3, Auricular point (NR)	No Acu, Homeo
Rossi24 [24]	16/20 wk*	1	16	NR	NR	NR	NA	GV20, EX-HN3, CV4, CV17, HT7, ST25, KI3, auricular point (Shenmen)	No Acu, Homeo, Acu+Homeo
Gao24 [25]	NR, but estimated 8–14 wk	NR	NR	NR	NR	NR	NA	NR	Mini Acu
Xie23 [26]	10 wk	1	10	30 min	0.20 x 25	9–24 mm	2 Hz	GV20, GV24, EX-HN1, CV4, CV12, PC6, HT7, LI4, ST36, SP6, KI3, KI6, LR3	Mini EA
Yan23 [27]	TBC according to CTx. cycle†	2	TBC†	NR	NR	Assumed to be > 3–5‡	2 Hz	NR	Mini EA
Zhao24 [28]	8 wk	2	16	30 min	0.30 x 25, 40	10–30	2–5 Hz	GV20, EX-HN1, EX-HN3, EX-HN5, GB15, CV12, CV6, TE5, HT7, LI4, ST36, ST40, SP6	Mini EA

Tx, treatment; int, intervention; wk, week; NR, not reported; TBC, to be confirmed; CTx, chemotherapy; freq, frequency; Acu, acupuncture; dur, duration; min, minute; EA, electroacupuncture; NA, Not applicable; Homeo, homeopathy; mini, minimal

* 8 wks of acu Tx., 4 wks of pause, and then 8 wks of acu Tx. again.

† Varies depending on the CTx cycle. To start 1 wk before CTx and complete 3 wks after CTx.. One cycle of CTx = about 4 wks.

‡ The depth of the acu group was not described. However, since the depth of needling performed in the control group is 3–5 mm, the needling depth of the acu group is expected to be the same or deeper.

Table 3-3

Outcome measures used in yet-to-be-published clinical studies on the effect of acupuncture for chemotherapy-related cognitive impairment

Study id	Time points (wk)	Outcome measures
		Cognitive function-related outcomes				Others
		Subjective	Objective	Biomarkers	Brain imaging	QOL	Fatigue	Anxiety	Insomnia	CTx. Tox	Safety
Rossi20 [23]	0, 12		Assessed by a neuropsychologist	Serum BDNF, proinflammatory cytokines
Rossi24 [24]	0, 12, End of CTx, 24	FACT-Cog	Assessed by a neuropsychologist including BSCE	Serum BDNF, proinflammatory cytokines
Gao24 [25]	0, 8, 14		MoCA, MMSE	proinflammatory cytokines		EORTC QLQ-C30
Xie23 [26]	0, 5, 10, 14	FACT-Cog v3	CANTAB	Serum BDNF, proinflammatory cytokines, mtDNA	Brain MRI	EORTC QLQ-C30 EQ-5D-5L, RSCL	MFSI-SF			CTCAE
Yan23 [27]	0, one day before 3rd CTx, 3 wks after final CTx	FACT-Cog	MoCA			FACT-General, PHQ-9		GAD-7	ISI	PRO-CTCAE	AE
Zhao24 [28]	0, 2, 4, 6, 8	FACT-Cog	MoCA			EORTC QLQ-C30	FACT, FACIT-fatigue			FAACT, FACT-BRM	CTCAE

Wk, week; CTx, chemotherapy; FACT-Cog, functional assessment of cancer treatment cognition; v3, version 3; BSCE, brief cognitive status exam; MoCA, Montreal cognitive assessment; MMSE, mini-mental state examination; CANTAB, Cambridge neuropsychological test automated battery; BDNF, blood-derived neurotrophic factor; mtDNA, mitochondrial DNA; MRI, magnetic resonance imaging; QOL, quality of life; EORTC QLQ-C30; European organization for research and treatment of cancer quality of life questionnaire core 30; EQ-5D-5L, Euro-Qol 5 dimensions 5 level questionnaire; RSCL, Rotterdam symptom checklist; FACT, functional assessment of cancer Tx; PHQ, patient health questionnaire; FACIT, functional assessment of chronic illness therapy; MFSI, multidimensional fatigue symptom inventory-short form; GAD, generalized anxiety disorder; ISI, insomnia severity index; Tox, toxicity; CTCAE, common terminology criteria for adverse events; PRO, patient reported outcomes; FAACT, functional assessment of anorexia/cachexia therapy; BRM, biologic response modifier; AE, adverse event

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