Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:24 AM
Study NCT ID:
NCT07481903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015671', 'term': 'Electroacupuncture'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Due to the specific nature of acupuncture clinical research, it is difficult to achieve double-blinding of participants and acupuncturists. Accordingly, this trial will blind only participants and outcome assessors. The outcome assessors will be independent of the study and will remain unaware of group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-15', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-15', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate of psychoneurological symptom cluster (after 8 weeks of treatment)', 'timeFrame': 'Week 8', 'description': 'The response rate is defined as the proportion of participants classified as responders. Improvement in each of the six psychoneurological symptoms is assessed using the following validated instruments: pain is measured by the Visual Analogue Scale (VAS); sleep quality by the Pittsburgh Sleep Quality Index (PSQI); fatigue by the Chinese version of the Brief Fatigue Inventory (BFI-C); anxiety and depression by the Hospital Anxiety and Depression Scale (HADS); and subjective cognitive function by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog). A participant is deemed a responder if the post treatment improvement from baseline meets or exceeds the minimum clinically important difference (MCID) for at least two of the six symptoms.'}], 'secondaryOutcomes': [{'measure': 'Response rate of psychoneurological symptom cluster (after 4 weeks of treatment and 12-week follow-up)', 'timeFrame': 'Week 4, Week 12', 'description': 'The definition and calculation method of the response rate are consistent with those of the primary outcome measure.'}, {'measure': 'Change from Baseline in the Functional Assessment of Cancer Therapy-Breast (FACT-B) Score', 'timeFrame': 'Baseline (Week 0), Week 4, Week 8, Week 12', 'description': 'Quality of life is measured by the Chinese version of FACT-B, which consists of 36 items. The total scale score ranges from 0 to 144, with higher scores indicating better quality of life.'}, {'measure': 'Change from Baseline in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Total and Subscale Scores', 'timeFrame': 'Baseline (Week 0), Week 4, Week 8, Week 12', 'description': 'The FACT-Cog is a 37-item self-response measure to assess cognitive concerns of cancer patients, consisting of four subscales: Perceived Cognitive Impairments (20 items, range 0-80), Comments from Others (4 items, range 0-16), Perceived Cognitive Abilities (9 items, range 0-36), and Impact on Quality of Life (4 items, range 0-16). A total cognitive functioning score is calculated as the sum of the four subscales. Higher scores indicate fewer cognitive difficulties.'}, {'measure': 'Change from Baseline in the Visual Analogue Scale (VAS) Score for Cancer/Treatment-Related Pain', 'timeFrame': 'Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12', 'description': 'The VAS intensity rating consists of a 10-cm line with the endpoints "no pain" and "worst pain". Study participants are asked to make a mark on the line that represents their current pain intensity, and the VAS pain intensity level is scored by measuring the distance from the "no pain" end of the line in millimeters.'}, {'measure': 'Change from Baseline in the Pittsburgh Sleep Quality Index (PSQI) Score', 'timeFrame': 'Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12', 'description': 'The PSQI consists of 18 items. Its global score ranges from 0 to 21, with higher scores indicating poor sleep quality and high sleep disturbance.'}, {'measure': 'Change from Baseline in the Brief Fatigue Inventory-Chinese Version (BFI-C) Score', 'timeFrame': 'Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12', 'description': 'The BFI-C consists of 9 items. Its total score ranges from 0 to 10, with higher scores indicating greater fatigue.'}, {'measure': 'Change from Baseline in the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A) Score', 'timeFrame': 'Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12', 'description': 'The HADS-A consists of 7 items. Its total score ranges from 0-21, with higher scores indicating more severe anxiety.'}, {'measure': 'Change from Baseline in the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D) Score', 'timeFrame': 'Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12', 'description': 'The HADS-D consists of 7 items. Its total score ranges from 0-21, with higher scores indicating more severe depression.'}, {'measure': 'Acupuncture Expectation Evaluation', 'timeFrame': 'Within 5 minutes after the first treatment', 'description': 'We will assess their expectations of acupuncture by asking questions after the first treatment. Participants will be asked two questions: "Do you think acupuncture may be effective?" and "Do you think acupuncture may be helpful for improving psychoneurological symptoms?". Their responses (Yes, No, or I don\'t know) will be collected for statistical analysis to evaluate the participants\' expectations of acupuncture.'}, {'measure': 'Blinding assessment', 'timeFrame': 'Within 5 minutes after the first treatment， Within 5 minutes after the last treatment', 'description': 'To evaluate the success of blinding among participants in this study, blinding assessment will be performed. Specifically, participants will be asked a specific question within 5 minutes after the first treatment and again within 5 minutes after the last treatment to ascertain their awareness of their group assignment.'}, {'measure': 'Safety Assessment', 'timeFrame': 'The entire study period (Week 0 [Baseline] to Week 12 [Follow-up])', 'description': 'The occurrence of acupuncture-related and general adverse events (including serious adverse events \\[SAEs\\]) is documented in detail throughout the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychoneurological Symptom Cluster', 'Breast Cancer', 'Acupuncture'], 'conditions': ['Psychoneurological Symptom Cluster(Pain, Insomnia, Anxiety, Fatigue, Depression, Subjective Cognitive Decline)', 'Pain', 'Insomnia', 'Anxiety', 'Fatigue', 'Depression', 'Subjective Cognitive Decline (SCD)']}, 'referencesModule': {'references': [{'pmid': '37981982', 'type': 'BACKGROUND', 'citation': 'Lu Y, Zhao Q, Zou J, Yan S, Tamaresis JS, Nelson L, Tu XM, Chen J, Tian L. A Composite Endpoint for Treatment Benefit According to Patient Preference. Stat Biopharm Res. 2022;14(4):408-422. doi: 10.1080/19466315.2022.2085783. Epub 2022 Jul 19.'}, {'pmid': '38713422', 'type': 'BACKGROUND', 'citation': 'Kwon KK, Lacey J, Kerin-Ayres K, Heller G, Grant S. Acupuncture for the treatment of the pain-fatigue-sleep disturbance-numbness/tingling symptom cluster in breast cancer survivors: a feasibility trial. Support Care Cancer. 2024 May 7;32(6):332. doi: 10.1007/s00520-024-08529-9.'}, {'pmid': '39858086', 'type': 'BACKGROUND', 'citation': 'Li H, Doorenbos AZ, Chen Z, Choi H, Ma W, Danciu O, Patil CL, Gao S, Lif N, Schlaeger JM. Feasibility and Acceptability of Integrating Acupuncture for Management of Multiple Symptoms in Medically Underserved Breast Cancer Survivors. Cancers (Basel). 2025 Jan 18;17(2):304. doi: 10.3390/cancers17020304.'}, {'pmid': '36948325', 'type': 'BACKGROUND', 'citation': 'Liao HY, Satyanarayanan SK, Lin YW, Su KP. Clinical efficacy and immune effects of acupuncture in patients with comorbid chronic pain and major depression disorder: A double-blinded, randomized controlled crossover study. Brain Behav Immun. 2023 May;110:339-347. doi: 10.1016/j.bbi.2023.03.016. Epub 2023 Mar 21.'}, {'pmid': '34437474', 'type': 'BACKGROUND', 'citation': 'Cui J, Song W, Jin Y, Xu H, Fan K, Lin D, Hao Z, Lin J. Research Progress on the Mechanism of the Acupuncture Regulating Neuro-Endocrine-Immune Network System. Vet Sci. 2021 Jul 30;8(8):149. doi: 10.3390/vetsci8080149.'}, {'pmid': '38314195', 'type': 'BACKGROUND', 'citation': 'Sun B, Cao X, Xin M, Guan R. Treatment of Depression with Acupuncture Based on Pathophysiological Mechanism. Int J Gen Med. 2024 Jan 31;17:347-357. doi: 10.2147/IJGM.S448031. eCollection 2024.'}, {'pmid': '32803635', 'type': 'BACKGROUND', 'citation': 'George MA, Lustberg MB, Orchard TS. Psychoneurological symptom cluster in breast cancer: the role of inflammation and diet. Breast Cancer Res Treat. 2020 Nov;184(1):1-9. doi: 10.1007/s10549-020-05808-x. Epub 2020 Aug 15.'}, {'pmid': '36229337', 'type': 'BACKGROUND', 'citation': 'Li H, Lockwood MB, Schlaeger JM, Liu T, Danciu OC, Doorenbos AZ. Tryptophan and Kynurenine Pathway Metabolites and Psychoneurological Symptoms Among Breast Cancer Survivors. Pain Manag Nurs. 2023 Feb;24(1):52-59. doi: 10.1016/j.pmn.2022.09.002. Epub 2022 Oct 10.'}, {'pmid': '36206160', 'type': 'BACKGROUND', 'citation': 'Grayson SC, Cummings MH, Wesmiller S, Bender C. The Cancer Genomic Integration Model for Symptom Science (CGIMSS): A Biopsychosocial Framework. Biol Res Nurs. 2023 Apr;25(2):210-219. doi: 10.1177/10998004221132250. Epub 2022 Oct 7.'}, {'pmid': '32305573', 'type': 'BACKGROUND', 'citation': 'Zhang ZJ, Man SC, Yam LL, Yiu CY, Leung RC, Qin ZS, Chan KS, Lee VHF, Kwong A, Yeung WF, So WKW, Ho LM, Dong YY. Electroacupuncture trigeminal nerve stimulation plus body acupuncture for chemotherapy-induced cognitive impairment in breast cancer patients: An assessor-participant blinded, randomized controlled trial. Brain Behav Immun. 2020 Aug;88:88-96. doi: 10.1016/j.bbi.2020.04.035. Epub 2020 Apr 16.'}, {'pmid': '35739000', 'type': 'BACKGROUND', 'citation': 'Tong QY, Liu R, Gao Y, Zhang K, Ma W, Shen WD. Effect of Electroacupuncture Based on ERAS for Preoperative Anxiety in Breast Cancer Surgery: A Single-Center, Randomized, Controlled Trial. Clin Breast Cancer. 2022 Oct;22(7):724-736. doi: 10.1016/j.clbc.2022.04.010. Epub 2022 Apr 30.'}, {'pmid': '37101228', 'type': 'BACKGROUND', 'citation': 'Zhang J, Qin Z, So TH, Chang TY, Yang S, Chen H, Yeung WF, Chung KF, Chan PY, Huang Y, Xu S, Chiang CY, Lao L, Zhang ZJ. Acupuncture for chemotherapy-associated insomnia in breast cancer patients: an assessor-participant blinded, randomized, sham-controlled trial. Breast Cancer Res. 2023 Apr 26;25(1):49. doi: 10.1186/s13058-023-01645-0.'}, {'pmid': '36367721', 'type': 'BACKGROUND', 'citation': 'Hershman DL, Unger JM, Greenlee H, Capodice J, Lew DL, Darke A, Minasian LM, Fisch MJ, Henry NL, Crew KD. Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor-Related Joint Pain: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2241720. doi: 10.1001/jamanetworkopen.2022.41720.'}, {'pmid': '23109700', 'type': 'BACKGROUND', 'citation': 'Molassiotis A, Bardy J, Finnegan-John J, Mackereth P, Ryder DW, Filshie J, Ream E, Richardson A. Acupuncture for cancer-related fatigue in patients with breast cancer: a pragmatic randomized controlled trial. J Clin Oncol. 2012 Dec 20;30(36):4470-6. doi: 10.1200/JCO.2012.41.6222. Epub 2012 Oct 29.'}, {'pmid': '34020137', 'type': 'BACKGROUND', 'citation': 'Sheikh-Wu SF, Kauffman MA, Anglade D, Shamsaldeen F, Ahn S, Downs CA. Effectiveness of different music interventions on managing symptoms in cancer survivors: A meta-analysis. Eur J Oncol Nurs. 2021 Jun;52:101968. doi: 10.1016/j.ejon.2021.101968. Epub 2021 Apr 24.'}, {'pmid': '22208450', 'type': 'BACKGROUND', 'citation': 'Kerr CW, Drake J, Milch RA, Brazeau DA, Skretny JA, Brazeau GA, Donnelly JP. Effects of methylphenidate on fatigue and depression: a randomized, double-blind, placebo-controlled trial. J Pain Symptom Manage. 2012 Jan;43(1):68-77. doi: 10.1016/j.jpainsymman.2011.03.026.'}, {'pmid': '22228391', 'type': 'BACKGROUND', 'citation': 'Kim HJ, Barsevick AM, Fang CY, Miaskowski C. Common biological pathways underlying the psychoneurological symptom cluster in cancer patients. Cancer Nurs. 2012 Nov-Dec;35(6):E1-E20. doi: 10.1097/NCC.0b013e318233a811.'}, {'pmid': '27789073', 'type': 'BACKGROUND', 'citation': 'Kwekkeboom KL. Cancer Symptom Cluster Management. Semin Oncol Nurs. 2016 Nov;32(4):373-382. doi: 10.1016/j.soncn.2016.08.004. Epub 2016 Oct 24.'}, {'pmid': '33749151', 'type': 'BACKGROUND', 'citation': 'So WKW, Law BMH, Ng MSN, He X, Chan DNS, Chan CWH, McCarthy AL. Symptom clusters experienced by breast cancer patients at various treatment stages: A systematic review. Cancer Med. 2021 Apr;10(8):2531-2565. doi: 10.1002/cam4.3794. Epub 2021 Mar 21.'}, {'pmid': '34921000', 'type': 'BACKGROUND', 'citation': 'Harris CS, Kober KM, Conley YP, Dhruva AA, Hammer MJ, Miaskowski CA. Symptom clusters in patients receiving chemotherapy: A systematic review. BMJ Support Palliat Care. 2022 Mar;12(1):10-21. doi: 10.1136/bmjspcare-2021-003325. Epub 2021 Dec 17.'}, {'pmid': '35838905', 'type': 'BACKGROUND', 'citation': 'Deo SVS, Sharma J, Kumar S. GLOBOCAN 2020 Report on Global Cancer Burden: Challenges and Opportunities for Surgical Oncologists. Ann Surg Oncol. 2022 Oct;29(11):6497-6500. doi: 10.1245/s10434-022-12151-6. Epub 2022 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to assess whether electroacupuncture (EA) can alleviate the psychoneurological symptom cluster (including pain, fatigue, insomnia, anxiety, depression and subjective cognitive decline) in breast cancer survivors, and to evaluate the safety of this therapy.\n\nResearchers will conduct a randomized controlled trial of electroacupuncture (EA) as compared to sham electroacupuncture (SA) in breast cancer survivors with the psychoneurological symptom cluster who are currently being treated with endocrine therapy.\n\nParticipants will receive 16 treatments over 8 weeks. The EA group will receive true acupuncture with continuous wave stimulation (2Hz, intensity as tolerated) administered for 30 minutes per session. The SA group will receive sham acupuncture using blunt (non-penetrating) needles that contact the skin without penetration, along with a 30-second transient device activation instead of the 30-minute continuous stimulation.\n\nTreatment outcomes for pain, fatigue, insomnia, anxiety, depression and subjective cognitive function will be assessed. The primary outcome is response rate of the psychoneurological symptom cluster after 8 weeks of treatment. Secondary outcomes include changes from baseline in the scores of each of the six psychoneurological symptoms.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria：\n\n1. Female, aged 18-75 years;\n2. Histologically confirmed Stage 0, I, II, or III breast cancer (according to the AJCC 8th edition)；\n3. Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least 1 month prior to study initiation , and are currently receiving endocrine therapy；\n4. Meet at least 2 of the following 6 criteria:\n\n(1)Visual Analogue Scale (VAS) score for pain ≥ 4 (2)Pittsburgh Sleep Quality Index (PSQI) score ≥ 8 (3)Brief Fatigue Inventory-Chinese version (BFI-C) score ≥ 4 (4)Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score ≥ 8 (5)Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) score ≥ 8 (6)Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments (FACT-Cog-PCI) score \\< 60 ; 5.Has signed the informed consent form and voluntarily participates in this study.\n\nExclusion Criteria:\n\n1. History of psychiatric disorders (e.g., bipolar disorder, schizophrenia, substance addiction)\n2. Presence of diseases that may impair cognitive function or interfere with study assessments (e.g., Alzheimer's disease, Parkinson's disease, brain tumors).\n3. Fatigue attributable to a treatable condition (e.g., hypothyroidism).\n4. Severe debilitation or significant organic disease (e.g., heart failure, severe hepatic/renal insufficiency, severe anemia, uncontrolled infection).\n5. Use of anxiolytics, antidepressants, psychostimulants, or sedative-hypnotics within the past 4 weeks.\n6. Chronic use of corticosteroids.\n7. Prior acupuncture treatment within 3 months, or participation in an acupuncture or drug clinical trial within 6 months.\n8. History of hemorrhagic disease, severe coagulation dysfunction, or current use of anticoagulants (e.g., warfarin).\n9. Implanted cardiac pacemaker.\n10. Pregnancy or breastfeeding.\n11. Concurrent participation in another clinical study."}, 'identificationModule': {'nctId': 'NCT07481903', 'briefTitle': 'Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine'}, 'officialTitle': 'Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors', 'orgStudyIdInfo': {'id': '7252224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EA group', 'description': 'Participants undergo 16 sessions of electroacupuncture twice weekly over 8 weeks.', 'interventionNames': ['Device: electroacupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'SA group', 'description': 'Participants undergo 16 sessions of sham electroacupuncture(noninsertive simulated acupuncture and sham electrical stimulation) twice weekly over 8 weeks.', 'interventionNames': ['Device: sham electroacupuncture']}], 'interventions': [{'name': 'electroacupuncture', 'type': 'DEVICE', 'description': "A semi-standardized protocol is used for participants in the EA group, which includes (1) standardized acupoints (Midline: Baihui \\[GV20\\], Shenting \\[GV24\\], Qihai \\[CV6\\], Guanyuan \\[CV4\\]; Bilateral: Fengchi \\[GB20\\], Taiyang \\[EX-HN5\\], Zusanli \\[ST36\\], Hegu \\[LI4\\], Taichong \\[LR3\\]); and (2) additional acupoints (Sishencong \\[EX-HN1\\] and bilateral Benshen \\[GB13\\] for anxiety/depression/subjective cognitive decline; 1-2 Ashi points for pain; no additional points for insomnia/fatigue). Meanwhile, electrical stimulation is conducted on three pairs of acupoints with electrode cord connection as follows: Baihui \\[GV20\\] and Shenting \\[GV24\\], left Fengchi \\[GB20\\] and left Taiyang \\[EX-HN5\\], right Fengchi \\[GB20\\] and right Taiyang \\[EX-HN5\\]. Electrical stimulation is delivered in continuous wave mode at 2 Hz with current intensity adjusted according to participant's tolerance. Electrical stimulation last 30 min. The needles on body acupoints are also retain for 30 min.", 'armGroupLabels': ['EA group']}, {'name': 'sham electroacupuncture', 'type': 'DEVICE', 'description': 'In the SA group, noninsertive simulated acupuncture and sham electrical stimulation(30-second transient device activation instead of 30-minute continuous stimulation) are used, while maintaining the same treatment duration and course as the EA group. Blunt needles are placed on 12 acupoints (Bilateral: Fengchi \\[GB20\\], Taiyang \\[EX-HN5\\], Zusanli \\[ST36\\], Hegu \\[LI4\\], Taichong \\[LR3\\]; Midline: Qihai \\[CV6\\], Guanyuan \\[CV4\\]) without skin penetration. Electrical stimulation is conducted on two pairs of acupoints with electrode cord connection as follows: left Fengchi \\[GB20\\] and left Taiyang \\[EX-HN5\\], right Fengchi \\[GB20\\] and right Taiyang \\[EX-HN5\\]. A 2 Hz continuous wave is delivered for 30 seconds, after which the EA device is immediately turned off. The blunt needles are maintained in position for 30 minutes to match the retention time in the EA group.', 'armGroupLabels': ['SA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100039', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Hua Song, PhD', 'role': 'CONTACT', 'email': 'dzliyujun@163.com', 'phone': '+86 10-66947798'}, {'name': 'Shaohua Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Senior Department of Oncology，Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100091', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'JuLing Jiang', 'role': 'CONTACT', 'email': '1192296624@qq.com', 'phone': '+86 10 62835438'}, {'name': 'ZhongNing Guo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xiyuan Hospital of CACMS', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Jing Lu', 'role': 'CONTACT', 'email': 'lujing0728@163.com', 'phone': '+86 25 68306522'}, {'name': 'Jing Lu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '266000', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'YiBo He', 'role': 'CONTACT', 'email': 'heyibozyy@126.com', 'phone': '+86 532 83777906'}, {'name': 'Bo Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Qingdao Traditional Chinese Medicine Hospital, Qingdao Hiser Hospital Affiliated of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'contacts': [{'name': 'Bin Wang, PhD', 'role': 'CONTACT', 'email': 'wbin8888@163.com', 'phone': '+86 22 23340123-6417'}, {'name': 'Bin Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Medical University Cancer Institute & Hospital (TMUCIH)', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '300381', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'contacts': [{'name': 'ZiYu Kuang, PhD', 'role': 'CONTACT', 'email': 'kzy1303088356@163.com', 'phone': '+86 22 27986525'}, {'name': 'FanMing Kong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Shiyan Yan', 'role': 'CONTACT', 'email': 'yanshiyan0927@sina.com', 'phone': '+86 22 27986078'}, {'name': 'Ruihan Guo', 'role': 'CONTACT', 'email': 'grh1882025@163.com', 'phone': '+86 135 2033 6216'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yan Shiyan', 'investigatorAffiliation': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine'}}}}