Acupuncture for QoL and Symptoms in Gastric Cancer During Adjuvant Chemotherapy

Sponsor

Guangzhou University of Traditional Chinese Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04360577

Collaborator

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

249

Enrollment

Locations

Arms

33.1

Anticipated Duration (Months)

22.6

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Primary Completion Date :

Dec 25, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

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

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

No Intervention: Usual care

Chemotherapy without acupuncture

Outcome Measures

Primary Outcome Measures

Total AUC of FACT-Gastric TOI [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

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 (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.
Total AUC of FACT-Gastric Scoring [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.
Average trajectory of FACT-Gastric Scoring 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. 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.
Total AUC of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric [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.
Average trajectory of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric [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.
Total AUC of Modified Edmonton Symptom Assessment Scale [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.
Average trajectory of Modified Edmonton Symptom Assessment Scale [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

Concentration of circulating myeloid-derived suppressor cells [At the end of Cycle 3 ( 21 days for one cycle)]
Myeloid-derived suppressor cells in peripheral blood will be detected using flow cytometry
Concentration of circulating Treg cells [At the end of Cycle 3 ( 21 days for one cycle)]
Treg cells in peripheral blood will be detected using flow cytometry
Number of Circulating tumor cells [At the end of Cycle 3 ( 21 days for one cycle)]
Circulating tumor cells in peripheral blood will be detected using microfluidic chip
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
1. 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;
1. 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;
1. Needle phobia;
1. Currently diagnosed with psychiatric disorder (e.g., severe depression, obsessive-compulsive disorder, or schizophrenia);
1. History of autoimmune diseases, hematological diseases or organ transplantation, or long term use of hormones or immunosuppressors;
1. Implanted with heart pacemaker;
1. Has accepted neoadjuvant radiotherapy before surgery;
1. Planning to accept adjuvant radiotherapy after surgery;
1. With active infection;
1. Acupuncture treatment within the previous 6 weeks;
10.Pregnant or lactating women.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foshan First People's Hospital	Foshan	Guangdong	China	528000
2	The first affiliated hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510000
3	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong	China	510120
4	Affiliated Cancer Hospital & Institute of Guangzhou Medical University	Guangzhou	Guangdong	China
5	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China
6	Sixth affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China
7	The first affiliated hospital of Guangzhou Medical University	Guangzhou	Guangdong	China
8	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong	China
9	Yue Bei People's Hospital	Shaoguan	Guangdong	China	512025
10	Fifth affiliated Hospital Sun Yat-Sen University	Zhuhai	Guangdong	China	519000
11	Affiliated Hospital of Nanjing University of Traditional Chinese Medicine	Nanjing	Jiangsu	China	210000