Acupuncture for QoL and Symptoms in Gastric Cancer During Adjuvant Chemotherapy

NCT04360577 | Completed

• 2 other identifiers: 2018KT1226-22017YFC1700603
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Stomach Neoplasms

Keywords

Gastric Cancer; Acupuncture; Quality of Life; Symptom Burden; Adjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Total AUC of FACT-Gastric TOI

  FACT-Gastric Scoring is designed for measurement of quality of life(QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING (PWB) SUBSCALE, FUNCTIONAL WELL BEING (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (GaCS) of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life. TOI for each patient will be recorded at baseline and once a week during the 3 cycles of chemotherapy (21 days for one cycle). The area under curve (AUCs) for each week are calculated by linear interpolation respectively, and then added together for the total AUC during the 3 cycles of chemotherapy.

  At the end of Cycle 3 ( 21 days for one cycle)

Secondary Outcomes (7)

• Average trajectory of FACT-Gastric TOI over time

  Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle)

• Total AUC of FACT-Gastric Scoring

  At the end of Cycle 3 ( 21 days for one cycle)

• Average trajectory of FACT-Gastric Scoring over time

  Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle)

• Total AUC of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric

  At the end of Cycle 3 ( 21 days for one cycle)

• Average trajectory of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric

  Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle)

Other Outcomes (4)

• Concentration of circulating myeloid-derived suppressor cells

  At the end of Cycle 3 ( 21 days for one cycle)

• Concentration of circulating Treg cells

  At the end of Cycle 3 ( 21 days for one cycle)

• Number of Circulating tumor cells

  At the end of Cycle 3 ( 21 days for one cycle)

Study Arms (3)

High-dose acupuncture

EXPERIMENTAL

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

Procedure: acupuncture

Low-dose acupuncture

EXPERIMENTAL

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

Procedure: acupuncture

Usual care

NO INTERVENTION

Chemotherapy without acupuncture

Interventions

acupuncture 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).

High-dose acupuncture; Low-dose acupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically diagnosed with gastric cancer or esophagogastric junction cancer after R0 resection and D2 lymph node dissection;
• Pathological stage II or stage III
• Without tumor recurrence confirmed by image examination;
• No chemotherapy after surgery, planning to accept at least 3 cycles of adjuvant chemotherapy;
• Age:18\~75 years old
• ECOG score≤ 2
• \. 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;
• \. Can understand the study well and finish the questionnaires in this study; 9. With the written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Affiliated Hospital of Nanjing University of Traditional Chinese Medicine: collaborator
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• Southern Medical University, China: collaborator
• Guangdong Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator
• First People's Hospital of Foshan: collaborator
• Yuebei People's Hospital: collaborator

Study Sites (11)

Foshan First People's Hospital

Foshan, Guangdong, 528000, China

Location

The first affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Sixth affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The first affiliated hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Yue Bei People's Hospital

Shaoguan, Guangdong, 512025, China

Location

Fifth affiliated Hospital Sun Yat-Sen University

Zhuhai, Guangdong, 519000, China

Location

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

Nanjing, Jiangsu, 210000, China

Location

Related Publications (2)

• 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.

  PMID: 41143548 DERIVED

• 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.

  PMID: 37434165 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Haibo Zhang, Prof.

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: May 27, 2020
• Primary Completion: March 23, 2023
• Study Completion: May 9, 2023
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (11)