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

Stomach Neoplasms Clinical Trial

Official title:

Effect of Acupuncture for Quality of Life in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753399
• Other study ID #: 2018KT1226
• Secondary ID: 2017YFC1700603
• Status: Completed
• Phase: N/A
• Start date: January 4, 2019
• Est. completion date: April 27, 2020

Study information

• Verified date: May 2021
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• acupuncture
Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong
China	The first affiliated hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Affiliated Hospital of Nanjing University of Traditional Chinese Medicine	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine	Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FACT-Gastric Trial Outcome Index (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 (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.	At the end of Cycle 3 (each cycle is 21 days)
Primary	Chinese version of Edmonton symptom assessment scale (C-ESAS)	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.	At the end of Cycle 3 (each cycle is 21 days)
Primary	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 (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.	Baseline (at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle).
Primary	Average trajectory of C-ESAS over time	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	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.
Secondary	Adherence to chemotherapy	Delay of adjuvant chemotherapy, complete rate of adjuvant chemotherapy	At the end of 3 cycles of treatment (21 days for each cycle).
Secondary	Concentration of Inflammatory factors in plasma detected with liquid chip	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, GROa, HGF, IFN?, IFNa, IL-1RA, IL-1ß, IL-1a, 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-1a, MIP-1ß, NGFß, PDGF-BB, PLGF, RANTES, SCF, SDF1a, TNFa, TNFß, VEGF-A, VEGF-D. The panel may be changed at detection according to possible new public articles or reports.	At the end of 3 cycles of treatment (21 days for each cycle).
Secondary	Concentration of circulating myeloid-derived suppressor cells detected with flow cytometry	Myeloid-derived suppressor cells in peripheral blood will be detected using flow cytometry	At the end of 3 cycles of treatment (21 days for each cycle).
Secondary	Concentration of Circulating CD8+ T lymph cells detected using flow cytometry	CD8+ T lymph cells in peripheral blood will be detected using flow cytometry	At the end of 3 cycles of treatment (21 days for each cycle).
Secondary	Number of Circulating tumor cells detected using microfluidic chip	Circulating tumor cells in peripheral blood will be detected using microfluidic chip	At the end of 3 cycles of treatment (21 days for each cycle).