Acupuncture for QoL and Symptoms in Gastric Cancer During Adjuvant Chemotherapy

Effect of Acupuncture for Quality of Life and Symptom Control in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Stomach Neoplasms
• Intervention / Treatment: Procedure: acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 249
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanjuan Zhu, Dr.; Phone Number: 34830 86 20 81887233; Email: zyjsophy@gzucm.edu.cn
• Study Contact Backup: Name: Xuesong Chang; Phone Number: 34830 86 20 81887233; Email: xuesongch2018@163.com

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Recruiting
      • Foshan First People's Hospital
      • Contact: Wei Wang, Dr; Phone Number: (+86)757-83833633
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Jiongqiang Huang, Prof.
    • Guangzhou, Guangdong, China
      • Recruiting
      • ZhuJiang Hospital of Southern Medical University
      • Contact: Jinlong Yu, Prof.
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Yong Li, Prof.
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Guangdong Provincial Hospital of Chinese Medicine
      • Contact: Yanjuan Zhu, Dr.; Phone Number: 34830 86 20 81887233; Email: zyjsophy@gzucm.edu.cn
      • Contact: Xuesong Chang, Dr.; Phone Number: 34830 86 20 81887233; Email: xuesongch2018@163.com
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sixth Affiliated Hospital, Sun Yat-sen University
      • Contact: Jian Xiao, Prof.
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The First Affiliated Hospital, Sun Yat-sen University
      • Contact: Jianjun Peng, Dr.; Phone Number: 86 20 28823388; Email: aidigua@hotmail.com
    • Guangzhou, Guangdong, China
      • Recruiting
      • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
      • Contact: Haiying Liu, Prof.
    • Shaoguan, Guangdong, China, 512025
      • Recruiting
      • Yue Bei People's Hospital
      • Contact: Tao Zhang, Dr; Phone Number: (86)751-8101207
    • Zhuhai, Guangdong, China, 519000
      • Recruiting
      • Fifth affiliated Hospital Sun Yat-Sen University
      • Contact: Hong-yu Zhang, Dr; Phone Number: (+86) 756-2528895
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
      • Contact: Xiaoyu Wu, Dr; Phone Number: 86 25 86617141; Email: wuxiaoyu@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-dose acupuncture; Acupuncture for 7 times every 3 weeks (one cycle of chemotherapy) for 9 weeks (3 cycles of chemotherapy)	Procedure: 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).
Experimental: Low-dose acupuncture; Acupuncture for 3 times every 3 weeks (one cycle of chemotherapy) for 9 weeks (3 cycles of chemotherapy)	Procedure: 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).
No Intervention: Usual care; Chemotherapy without acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average trajectory of FACT-Gastric TOI over time	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.	Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle)
Total AUC of FACT-Gastric Scoring	FACT-Gastric Scoring is designed for measurement of quality of life(QoL) for gastric cancer patients. It is composed of PHYSICAL WELL BEING (PWB) SUBSCALE, SOCIAL WELL BEING (SWB) SUBSCALE, EMOTIONAL WELL BEING (EWB) SUBSCALE, FUNCTIONAL WELL BEING (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (GaCS). The range of FACT-Gastric scoring is 0-184. The higher the score, the better the quality of life. FACT-Gastric scoring 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)
Average trajectory of FACT-Gastric Scoring over time	FACT-Gastric Scoring is designed for measurement of quality of life(QoL) for gastric cancer patients. It is composed of PHYSICAL WELL BEING (PWB) SUBSCALE, SOCIAL WELL BEING (SWB) SUBSCALE, EMOTIONAL WELL BEING (EWB) SUBSCALE, FUNCTIONAL WELL BEING (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (GaCS). The range of FACT-Gastric scoring is 0-184. The higher the score, the better the quality of life.	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	The GaCS of FACT-Gastric focuses on the symptoms and functions related to gastric cancer specifically. The range of GaCS is 0-76. The higher the score, the better the quality of life. GaCS 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)
Average trajectory of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric	The GaCS of FACT-Gastric focuses on the symptoms and functions related to gastric cancer specifically. The range of GaCS is 0-76. The higher the score, the better the quality of life.	Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle)
Total AUC of Modified Edmonton Symptom Assessment Scale	Edmonton symptom assessment scale (ESAS) is a questionnaire used for symptom assessment in cancer patients. It was composed of 10 items with score range of 0-10 for each item, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, shortness of breath, and other. ESAS was then modified in 2015, with additional symptoms of constipation and sleep. The higher the score, the worse the symptom is. ESAS scoring for each patient will be recorded everyday in the first week, and then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle). The AUCs 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)
Average trajectory of Modified Edmonton Symptom Assessment Scale	Edmonton symptom assessment scale (ESAS) is a questionnaire used for symptom assessment in cancer patients. It was composed of 10 items with score range of 0-10 for each item, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, shortness of breath, and other. ESAS was then modified in 2015, with additional symptoms of constipation and sleep. The higher the score, the worse the symptom is.	Everyday in the first week, then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Treatment-emergent adverse events is defined as any adverse events happened after randomization. The severity is validated using NCI-CTCAE V4.0.	Adverse events will be assessed during the period of 3 cycles of treatment (21 days for each cycle), since the date of randomization. Adverse events will be recorded once any side effect happens.
Concentration of circulating myeloid-derived suppressor cells	Myeloid-derived suppressor cells in peripheral blood will be detected using flow cytometry	At the end of Cycle 3 ( 21 days for one cycle)
Concentration of circulating Treg cells	Treg cells in peripheral blood will be detected using flow cytometry	At the end of Cycle 3 ( 21 days for one cycle)
Number of Circulating tumor cells	Circulating tumor cells in peripheral blood will be detected using microfluidic chip	At the end of Cycle 3 ( 21 days for one cycle)

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Guangdong Provincial People's Hospital; The First Affiliated Hospital of Guangzhou Medical University; Sixth Affiliated Hospital, Sun Yat-sen University; Fifth Affiliated Hospital, Sun Yat-Sen University; First People's Hospital of Foshan; Affiliated Cancer Hospital & Institute of Guangzhou Medical University; Southern Medical University, China; Yuebei People's Hospital; Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Haibo Zhang, Prof., Guangdong Provincial Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2020
• Primary Completion (Anticipated): December 25, 2022
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Quality of Life; Acupuncture; Gastric Cancer; Symptom Burden; Adjuvant Chemotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2018KT1226-2; 2017YFC1700603 (Other Grant/Funding Number: The National Key Research and Development Program of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD can be obtained from the PI with application after article publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No