Acupuncture for QoL and Symptoms in Gastric Cancer During Adjuvant Chemotherapy

NCT ID: NCT04360577

Last Updated: 2024-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-27

Study Completion Date

2023-05-09

Brief Summary

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In the investigator's pilot study(NCT 03753399), a trend of improvement of quality of life, as well as release of symptoms, in gastric patients in acupuncture groups was indicated. This study will evaluate the efficacy of acupuncture on QoL in gastric cancer patients undergoing postoperative adjuvant chemotherapy with more samples. Enrolled participates will randomly receive high-dose acupuncture, low-dose acupuncture or non-acupuncture during the first 3 cycles of adjuvant chemotherapy after resection.

Detailed Description

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Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-dose acupuncture

Acupuncture for 7 times every 3 weeks (one cycle of chemotherapy) for 9 weeks (3 cycles of chemotherapy)

Group Type EXPERIMENTAL

acupuncture

Intervention Type PROCEDURE

Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combing with electro-acupuncture at Baihui(GV20), Yintang(GV29), Neiguan(PC6), Zusanli(ST36), and Gongsun(SP4).

Low-dose acupuncture

Acupuncture for 3 times every 3 weeks (one cycle of chemotherapy) for 9 weeks (3 cycles of chemotherapy)

Group Type EXPERIMENTAL

acupuncture

Intervention Type PROCEDURE

Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combing with electro-acupuncture at Baihui(GV20), Yintang(GV29), Neiguan(PC6), Zusanli(ST36), and Gongsun(SP4).

Usual care

Chemotherapy without acupuncture

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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acupuncture

Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combing with electro-acupuncture at Baihui(GV20), Yintang(GV29), Neiguan(PC6), Zusanli(ST36), and Gongsun(SP4).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1.Pathologically diagnosed with gastric cancer or esophagogastric junction cancer after R0 resection and D2 lymph node dissection;
* 2.Pathological stage II or stage III
* 3.Without tumor recurrence confirmed by image examination;
* 4.No chemotherapy after surgery, planning to accept at least 3 cycles of adjuvant chemotherapy;
* 5.Age:18\~75 years old
* 6.ECOG score≤ 2
* 7\. Normal organ function, including: 7.1 Bone marrow function: absolute neutrophil count (ANC)≥1.5×10e9/L, platelet (PLT)≥100×10e9/ L,hemoglobin (Hb)≥90g/L; 7.2 Kidney function: Serum creatinine (Scr)≤1.5mg/dl(133μmol/L), or creatinine clearance rate (Ccr)≥60ml/min; 7.3 Liver function: Total bilirubin (TB)≤1.5×upper limit of normal value (ULN), Alanine transaminase (ALT)≤2.5×ULN, Aspartate transaminase (AST)≤2.5×ULN;
* 8\. Can understand the study well and finish the questionnaires in this study; 9. With the written informed consent.

Exclusion Criteria

* 1\. Can not finish the baseline assessment;
* 2\. Needle phobia;
* 3\. Currently diagnosed with psychiatric disorder (e.g., severe depression, obsessive-compulsive disorder, or schizophrenia);
* 4\. History of autoimmune diseases, hematological diseases or organ transplantation, or long term use of hormones or immunosuppressors;
* 5\. Implanted with heart pacemaker;
* 6\. Has accepted neoadjuvant radiotherapy before surgery;
* 7\. Planning to accept adjuvant radiotherapy after surgery;
* 8\. With active infection;
* 9\. Acupuncture treatment within the previous 6 weeks;
* 10.Pregnant or lactating women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role collaborator

Southern Medical University, China

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

First People's Hospital of Foshan

OTHER

Sponsor Role collaborator

Yuebei People's Hospital

OTHER

Sponsor Role collaborator

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haibo Zhang, Prof.

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

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Foshan First People's Hospital

Foshan, Guangdong, China

Site Status

The first affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Site Status

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status

Sixth affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

The first affiliated hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

Yue Bei People's Hospital

Shaoguan, Guangdong, China

Site Status

Fifth affiliated Hospital Sun Yat-Sen University

Zhuhai, Guangdong, China

Site Status

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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Zhu YJ, Chang XS, Wu XY, Wang W, Diao DC, Li Y, Zhang HY, Xiao J, Zhai XH, Yu JL, Wang W, Zhou JX, Huang ZL, Zhang T, Ouyang W, Janjigian YY, Cytryn SL, Xiao ZZ, Liu YH, Zhou R, Ma HC, Chen YD, Peng JJ, Mao JJ, Zhang HB. Electro-acupuncture for quality of life during adjuvant chemotherapy in gastric cancer: a randomized trial. J Natl Cancer Inst. 2025 Oct 27:djaf309. doi: 10.1093/jnci/djaf309. Online ahead of print.

Reference Type DERIVED
PMID: 41143548 (View on PubMed)

Chang X, Zhu Y, Zhao W, Liu Y, He Y, Chen Y, Xu D, Mao JJ, Zhang HB. Electro-acupuncture for health-related quality of life and symptoms in patients with gastric cancer undergoing adjuvant chemotherapy (EAGER): a protocol for a multicenter randomized controlled trial. Health Qual Life Outcomes. 2023 Jul 11;21(1):70. doi: 10.1186/s12955-023-02135-9.

Reference Type DERIVED
PMID: 37434165 (View on PubMed)

Other Identifiers

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2017YFC1700603

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2018KT1226-2

Identifier Type: -

Identifier Source: org_study_id

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