Effect of Acupuncture for QoL in Gastric Cancer Patients Undergoing Adjuvant Chemotherapy: a Pilot Study

Not Applicable

Completed

• Conditions: Stomach Neoplasms
• Interventions: Procedure: acupuncture

• Registration Number: NCT03753399
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-27
• Study Start: 2019-01-04
• Primary Completion: 2020-04-27
• Study Completion: 2020-04-27
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-19
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose acupuncture	acupuncture	Acupuncture for 3 times every 3 weeks (a cycle of chemotherapy) for 9 weeks
High-dose acupuncture	acupuncture	Acupuncture for 7 times every 3 weeks (a cycle of chemotherapy) for 9 weeks

Primary Outcome Measures

Name	Time	Method
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).	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.
FACT-Gastric Trial Outcome Index (TOI)	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.
Chinese version of Edmonton symptom assessment scale (C-ESAS)	At the end of Cycle 3 (each cycle is 21 days)	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.
Average trajectory of C-ESAS over time	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.

Secondary Outcome Measures

Name	Time	Method
Adherence to chemotherapy	At the end of 3 cycles of treatment (21 days for each cycle).	Delay of adjuvant chemotherapy, complete rate of adjuvant chemotherapy
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	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.
Concentration of Inflammatory factors in plasma detected with liquid chip	At the end of 3 cycles of treatment (21 days for each cycle).	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.
Concentration of circulating myeloid-derived suppressor cells detected with flow cytometry	At the end of 3 cycles of treatment (21 days for each cycle).	Myeloid-derived suppressor cells in peripheral blood will be detected using flow cytometry
Number of Circulating tumor cells detected using microfluidic chip	At the end of 3 cycles of treatment (21 days for each cycle).	Circulating tumor cells in peripheral blood will be detected using microfluidic chip
Concentration of Circulating CD8+ T lymph cells detected using flow cytometry	At the end of 3 cycles of treatment (21 days for each cycle).	CD8+ T lymph cells in peripheral blood will be detected using flow cytometry

Trial Locations

Locations (3)

The first affiliated hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine; 🇨🇳 Nanjing, Jiangsu, China