Clinical trial NCT04360577: Acupuncture for QoL and Symptoms in Gastric Cancer During Adjuvant Chemotherapy
Official title: Effect of Acupuncture for Quality of Life and Symptom Control in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Neoplasms
Keywords: Gastric Cancer
Acupuncture
Quality of Life
Symptom Burden
Adjuvant Chemotherapy
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
name: Sixth Affiliated Hospital, Sun Yat-sen University
name: Southern Medical University, China
name: Guangdong Provincial People's Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Fifth Affiliated Hospital, Sun Yat-Sen University
name: First People's Hospital of Foshan
name: Yuebei People's Hospital
First posted: 2020-04-24
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total AUC of FACT-Gastric TOI
timeFrame: At the end of Cycle 3 ( 21 days for one cycle)
Secondary outcomes:
measure: Average trajectory of FACT-Gastric TOI over time
timeFrame: Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle)
measure: Total AUC of FACT-Gastric Scoring
timeFrame: At the end of Cycle 3 ( 21 days for one cycle)
measure: Average trajectory of FACT-Gastric Scoring over time
timeFrame: Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle)
measure: Total AUC of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric
timeFrame: At the end of Cycle 3 ( 21 days for one cycle)
measure: Average trajectory of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric
timeFrame: Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle)
measure: Total AUC of Modified Edmonton Symptom Assessment Scale
timeFrame: At the end of Cycle 3 ( 21 days for one cycle)
measure: Average trajectory of Modified Edmonton Symptom Assessment Scale
timeFrame: Everyday in the first week, then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle)
Other outcomes:
measure: Concentration of circulating myeloid-derived suppressor cells
timeFrame: At the end of Cycle 3 ( 21 days for one cycle)
measure: Concentration of circulating Treg cells
timeFrame: At the end of Cycle 3 ( 21 days for one cycle)
measure: Number of Circulating tumor cells
timeFrame: At the end of Cycle 3 ( 21 days for one cycle)
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 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.
Locations:
city: Foshan
country: China
facility: Foshan First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The first affiliated hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sixth affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The first affiliated hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Shaoguan
country: China
facility: Yue Bei People's Hospital
state: Guangdong
city: Zhuhai
country: China
facility: Fifth affiliated Hospital Sun Yat-Sen University
state: Guangdong
city: Nanjing
country: China
facility: Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
state: Jiangsu
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Haibo Zhang, Prof.
role: PRINCIPAL_INVESTIGATOR
References: