Acupuncture for QoL and Symptoms in Gastric Cancer During Adjuvant Chemotherapy

Guangzhou University of Traditional Chinese Medicine

Status: Completed

Conditions: Stomach Neoplasms

Treatments: Procedure: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04360577

2018KT1226-2

2017YFC1700603 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

High-dose acupuncture

Experimental group

Description:

Acupuncture for 7 times every 3 weeks (one cycle of chemotherapy) for 9 weeks (3 cycles of chemotherapy)

Treatment:

Procedure: acupuncture

Low-dose acupuncture

Experimental group

Description:

Acupuncture for 3 times every 3 weeks (one cycle of chemotherapy) for 9 weeks (3 cycles of chemotherapy)

Treatment:

Procedure: acupuncture

Usual care

No Intervention group

Description:

Chemotherapy without acupuncture