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

Guangzhou University of Traditional Chinese Medicine

Status: Completed

Conditions: Stomach Neoplasms

Treatments: Procedure: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03753399

2018KT1226

2017YFC1700603 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 66 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

High-dose acupuncture

Experimental group

Description:

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

Treatment:

Procedure: acupuncture

Low-dose acupuncture

Experimental group

Description:

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

Treatment:

Procedure: acupuncture

Usual care

No Intervention group

Description:

Chemotherapy without acupuncture