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

NCT ID: NCT03753399

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2020-04-27

Brief Summary

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.

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High-dose acupuncture

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

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: PROCEDURE

Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.

Low-dose acupuncture

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

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: PROCEDURE

Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.

Usual care

Chemotherapy without acupuncture

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture

Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.

Intervention Type: PROCEDURE

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Haibo Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The first affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

2017YFC1700603

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2018KT1226

Identifier Type: -

Identifier Source: org_study_id