Acupuncture for QoL and Symptoms in Gastric Cancer During Adjuvant Chemotherapy

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04360577
• Other study ID #: 2018KT1226-2
• Secondary ID: 2017YFC1700603
• Status: Completed
• Phase: N/A
• Start date: May 27, 2020
• Est. completion date: May 9, 2023

Study information

• Verified date: June 2024
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 9, 2023
• Est. primary completion date: March 23, 2023
• 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 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.

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

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).

Locations

Country	Name	City	State
China	Foshan First People's Hospital	Foshan	Guangdong
China	Affiliated Cancer Hospital & Institute of Guangzhou Medical University	Guangzhou	Guangdong
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Sixth affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The first affiliated hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The first affiliated hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Affiliated Hospital of Nanjing University of Traditional Chinese Medicine	Nanjing	Jiangsu
China	Yue Bei People's Hospital	Shaoguan	Guangdong
China	Fifth affiliated Hospital Sun Yat-Sen University	Zhuhai	Guangdong

Sponsors (11)

Lead Sponsor

Collaborator

Guangzhou University of Traditional Chinese Medicine

Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Fifth Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital, Sun Yat-Sen University, First People's Hospital of Foshan, Guangdong Provincial People's Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Southern Medical University, China, The First Affiliated Hospital of Guangzhou Medical University, Yuebei People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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.
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)