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Acupuncture for QoL and Symptoms in Gastric Cancer During Adjuvant Chemotherapy

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ClinicalTrials.gov Identifier: NCT04360577
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : May 21, 2021
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Sixth Affiliated Hospital, Sun Yat-sen University
Southern Medical University, China
Guangdong Provincial People's Hospital
The First Affiliated Hospital of Guangzhou Medical University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Fifth Affiliated Hospital, Sun Yat-Sen University
Foshan First People's Hospital
Yuebei People's Hospital
Information provided by (Responsible Party):
Guangzhou University of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Procedure: acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Acupuncture for Quality of Life and Symptom Control in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy
Actual Study Start Date : May 27, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Total AUC of FACT-Gastric TOI [ Time Frame: At the end of Cycle 3 ( 21 days for one cycle) ]
    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.


Secondary Outcome Measures :
  1. Average trajectory of FACT-Gastric TOI over time [ Time Frame: Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle) ]
    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.

  2. Total AUC of FACT-Gastric Scoring [ Time Frame: At the end of Cycle 3 ( 21 days for one cycle) ]
    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.

  3. Average trajectory of FACT-Gastric Scoring over time [ Time Frame: Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle) ]
    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.

  4. Total AUC of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric [ Time Frame: At the end of Cycle 3 ( 21 days for one cycle) ]
    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.

  5. Average trajectory of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric [ Time Frame: Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle) ]
    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.

  6. Total AUC of Modified Edmonton Symptom Assessment Scale [ Time Frame: At the end of Cycle 3 ( 21 days for one cycle) ]
    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.

  7. Average trajectory of Modified Edmonton Symptom Assessment Scale [ Time Frame: Everyday in the first week, then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle) ]
    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.


Other Outcome Measures:
  1. Concentration of circulating myeloid-derived suppressor cells [ Time Frame: At the end of Cycle 3 ( 21 days for one cycle) ]
    Myeloid-derived suppressor cells in peripheral blood will be detected using flow cytometry

  2. Concentration of circulating Treg cells [ Time Frame: At the end of Cycle 3 ( 21 days for one cycle) ]
    Treg cells in peripheral blood will be detected using flow cytometry

  3. Number of Circulating tumor cells [ Time Frame: At the end of Cycle 3 ( 21 days for one cycle) ]
    Circulating tumor cells in peripheral blood will be detected using microfluidic chip

  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 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. ]
    Treatment-emergent adverse events is defined as any adverse events happened after randomization. The severity is validated using NCI-CTCAE V4.0.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360577


Contacts
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Contact: Yanjuan Zhu, Dr. 86 20 81887233 ext 34830 zyjsophy@gzucm.edu.cn
Contact: Xuesong Chang 86 20 81887233 ext 34830 xuesongch2018@163.com

Locations
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China, Guangdong
Foshan First People's Hospital Recruiting
Foshan, Guangdong, China, 528000
Contact: Wei Wang, Dr    (+86)757-83833633      
The first affiliated hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Jianjun Peng, Dr.    86 20 28823388    aidigua@hotmail.com   
Guangdong Provincial Hospital of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Yanjuan Zhu, Dr.    86 20 81887233 ext 34830    zyjsophy@gzucm.edu.cn   
Contact: Xuesong Chang, Dr.    86 20 81887233 ext 34830    xuesongch2018@163.com   
Principal Investigator: Haibo Zhang, Professor         
Affiliated Cancer Hospital & Institute of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Haiying Liu, Prof.         
Guangdong Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Yong Li, Prof.         
Sixth affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Jian Xiao, Prof.         
The first affiliated hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Jiongqiang Huang, Prof.         
Zhujiang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Jinlong Yu, Prof.         
Yue Bei People's Hospital Recruiting
Shaoguan, Guangdong, China, 512025
Contact: Tao Zhang, Dr    (86)751-8101207      
Fifth affiliated Hospital Sun Yat-Sen University Recruiting
Zhuhai, Guangdong, China, 519000
Contact: Hong-yu Zhang, Dr    (+86) 756-2528895      
China, Jiangsu
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Xiaoyu Wu, Dr    86 25 86617141    wuxiaoyu@medmail.com.cn   
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
First Affiliated Hospital, Sun Yat-Sen University
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Sixth Affiliated Hospital, Sun Yat-sen University
Southern Medical University, China
Guangdong Provincial People's Hospital
The First Affiliated Hospital of Guangzhou Medical University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Fifth Affiliated Hospital, Sun Yat-Sen University
Foshan First People's Hospital
Yuebei People's Hospital
Investigators
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Principal Investigator: Haibo Zhang, Prof. Guangdong Provincial Hospital of Traditional Chinese Medicine
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Responsible Party: Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT04360577    
Other Study ID Numbers: 2018KT1226-2
2017YFC1700603 ( Other Grant/Funding Number: The National Key Research and Development Program of China )
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD can be obtained from the PI with application after article publication.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guangzhou University of Traditional Chinese Medicine:
Gastric Cancer
Acupuncture
Quality of Life
Symptom Burden
Adjuvant Chemotherapy
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases