- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03753399
Effect of Acupuncture for QoL in Gastric Cancer Patients Undergoing Adjuvant Chemotherapy: a Pilot Study
May 19, 2021 updated by: Haibo Zhang, Guangzhou University of Traditional Chinese Medicine
Effect of Acupuncture for Quality of Life in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy: a Pilot Study
This is a pilot study evaluating the efficacy of acupuncture on quality of life in gastric cancer patients undergoing postoperative adjuvant chemotherapy.
Enrolled participates will randomly receive high-dose acupuncture, low-dose acupuncture or none-acupuncture during the first 3 cycles of adjuvant chemotherapy after resection.
Study Overview
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510000
- The First Affiliated Hospital, Sun Yat-sen University
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Guangzhou, Guangdong, China, 510120
- Guangdong Provincial Hospital of Chinese Medicine
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Jiangsu
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Nanjing, Jiangsu, China, 210000
- Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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 organs 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High-dose acupuncture
Acupuncture for 7 times every 3 weeks (a cycle of chemotherapy) for 9 weeks
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Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.
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EXPERIMENTAL: Low-dose acupuncture
Acupuncture for 3 times every 3 weeks (a cycle of chemotherapy) for 9 weeks
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Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.
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NO_INTERVENTION: Usual care
Chemotherapy without acupuncture
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FACT-Gastric Trial Outcome Index (TOI)
Time Frame: At the end of Cycle 3 (each cycle is 21 days)
|
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 (PWB)SUBSCALE and GASTRIC CANCER SUBSCALE(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.
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At the end of Cycle 3 (each cycle is 21 days)
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Chinese version of Edmonton symptom assessment scale (C-ESAS)
Time Frame: At the end of Cycle 3 (each cycle is 21 days)
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Chinese version of Edmonton symptom assessment scale (C-ESAS) is a questionnaire used for symptom assessment in cancer patients.
C-ESAS is composed of 11 items with score range of 0-10 for each item.
The higher the score, the worse the symptom is.
We don't include inching item in our study because the inching is common in gastrointestinal department patients rather than cancer patients.
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At the end of Cycle 3 (each cycle is 21 days)
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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 (PWB)SUBSCALE and GASTRIC CANCER SUBSCALE(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.
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Baseline (at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle).
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Average trajectory of C-ESAS over time
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)
|
Chinese version of Edmonton symptom assessment scale (C-ESAS) is a questionnaire used for symptom assessment in cancer patients.
C-ESAS is composed of 11 items with score range of 0-10 for each item.
The higher the score, the worse the symptom is.
We don't include inching item in our study because the inching is common in gastrointestinal department patients rather than cancer patients.
|
Everyday in the first week, then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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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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.
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Adherence to chemotherapy
Time Frame: At the end of 3 cycles of treatment (21 days for each cycle).
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Delay of adjuvant chemotherapy, complete rate of adjuvant chemotherapy
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At the end of 3 cycles of treatment (21 days for each cycle).
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Concentration of Inflammatory factors in plasma detected with liquid chip
Time Frame: At the end of 3 cycles of treatment (21 days for each cycle).
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Plasma will be stored at -80℃.
Inflammatory factors in plasma will be detected using a liquid chip panel when all patients have finished treatment.
the panel is planned to contain 45 inflammatory factors and cytokines, including BDNF, EGF, Eotaxin, FGF-basic, GM-CSF, GROα, HGF, IFNγ, IFNα, IL-1RA, IL-1β, IL-1α, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 p70, IL-13, IL-15, IL-17A, IL-18, IL-21, IL-22, IL-23, IL-27, IL-31, IP-10, LIF, MCP-1, MIP-1α, MIP-1β, NGFβ, PDGF-BB, PLGF, RANTES, SCF, SDF1α, TNFα, TNFβ, VEGF-A, VEGF-D.
The panel may be changed at detection according to possible new public articles or reports.
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At the end of 3 cycles of treatment (21 days for each cycle).
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Concentration of circulating myeloid-derived suppressor cells detected with flow cytometry
Time Frame: At the end of 3 cycles of treatment (21 days for each cycle).
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Myeloid-derived suppressor cells in peripheral blood will be detected using flow cytometry
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At the end of 3 cycles of treatment (21 days for each cycle).
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Concentration of Circulating CD8+ T lymph cells detected using flow cytometry
Time Frame: At the end of 3 cycles of treatment (21 days for each cycle).
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CD8+ T lymph cells in peripheral blood will be detected using flow cytometry
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At the end of 3 cycles of treatment (21 days for each cycle).
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Number of Circulating tumor cells detected using microfluidic chip
Time Frame: At the end of 3 cycles of treatment (21 days for each cycle).
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Circulating tumor cells in peripheral blood will be detected using microfluidic chip
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At the end of 3 cycles of treatment (21 days for each cycle).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 4, 2019
Primary Completion (ACTUAL)
April 27, 2020
Study Completion (ACTUAL)
April 27, 2020
Study Registration Dates
First Submitted
November 16, 2018
First Submitted That Met QC Criteria
November 21, 2018
First Posted (ACTUAL)
November 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
May 20, 2021
Last Update Submitted That Met QC Criteria
May 19, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018KT1226
- 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)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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