Acupuncture Combined With Chemotherapy for Gastric Cancer After Surgery

NCT07098949 | Not Yet Recruiting DMC

• 1 other identifier: 2024ZD0521302
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 3

Brief Summary

This multicenter, randomized, parallel-group clinical trial aims to evaluate the efficacy of acupuncture combined with adjuvant chemotherapy in patients with gastric cancer who have undergone surgery. Participants will be randomly assigned in a 1:1 ratio to receive either acupuncture or sham acupuncture during the adjuvant chemotherapy period.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Accupuncture; Adjuvant chemotherapy; Recurrence

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, whichever occurs first, assessed up to 5 years.

Secondary Outcomes (11)

• Average trajectory of FACT-Gastric TOI over time

  Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis

• Total AUC of FACT-Gastric TOI

  Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis

• Average trajectory of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric

  Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis

• Total AUC of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric

  Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis

• Average trajectory of FACT-Gastric Scoring over time

  Assessed at baseline (Day1 at randomization), the first week of each Cycle 1-4 (each cycle is 21 days), the first day of Cycle 5 (each cycle is 21 days), and the time of recurrence or metastasis identified through CT/MRI imaging diagnosis

Other Outcomes (2)

• Traditional Chinese medicine syndrome data

  Assessed on the last day of each chemotherapy cycle (each cycle is 21 days), up to treatment completion (maximum 8 cycles).

• Adverse events

  Assessed within 1 day prior to each cycle of chemotherapy ( 21 days per cycle), up to treatment completion (maximum 8 cycles).

Study Arms (2)

Acupuncture Treatment Group

EXPERIMENTAL

Acupuncture for three times every 3 weeks(once a week, one cycle of adjuvant chemotherapy), a total of 4 cycles of adjuvant chemotherapy.

Other: Acupuncture; Drug: Chemotherapy

Sham Acupuncture Group

SHAM COMPARATOR

Sham acupuncture procedure at the same acupoints and treatment schedule as the acupuncture group, utilizing a blunt-tipped sham needle for superficial pressure.

Other: Sham Acupuncture; Drug: Chemotherapy

Interventions

Acupuncture OTHER

The patient takes a sitting or lateral position. The following acupoints are selected Baihui (GV20), Yintang (EX-HN3), Zhongwan (CV12), Bilateral Neiguan (PC6), Bilateral Zusanli (ST36), Bilateral Sanyinjiao (SP6), Bilateral Gongsun (SP4), Bilateral Pishu (BL20). Electroacupuncture is applied at bilateral Sanyinjiao (SP6) and bilateral Zusanli (ST36) by connecting them to an electroacupuncture device. The needles are retained for 30 minutes.

Acupuncture Treatment Group

Sham Acupuncture OTHER

sham acupuncture procedure that mirrors the acupuncture treatment in terms of acupoint selection and treatment schedule. However, instead of actual needle insertion, a blunt-tipped sham needle will be used to apply superficial pressure at the designated acupoints. The design of the sham needle includes a base that allows for simulated insertion, providing patients with a mild sensation of pressure and a visual cue as the needle appears to move toward the skin. This innovative approach ensures that while participants experience a similar tactile sensation, there is no penetration of the skin, distinguishing it clearly from the actual acupuncture treatment.

Sham Acupuncture Group

Chemotherapy DRUG

Adjuvant chemotherapy with either the XELOX (capecitabine + oxaliplatin) or SOX (S-1 + oxaliplatin) regimen

Acupuncture Treatment Group; Sham Acupuncture Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with gastric cancer who have undergone R0 resection of the stomach/ distal stomach with D2 lymphadenectomy and are planned to receive postoperative adjuvant chemotherapy
• Postoperative pathological diagnosis of gastric cancer, with pathological staging of pII/pIII (American Joint Committee on Cancer, AJCC)
• No recurrence or metastasis confirmed by imaging examination
• Performance Status (PS) score of 0-2
• Age between 18 and 75 years
• Normal bone marrow, liver, and kidney function:
• Normal bone marrow function: Neutrophil count ≥1.5×10\^9/L, platelet count ≥100×10\^9/L, hemoglobin ≥90g/L
• Normal kidney function: Serum creatinine ≤1.5mg/dl (133μmol/L) and/or creatinine clearance ≥60ml/min
• Normal liver function: Total serum bilirubin level ≤1.5 times the upper limit of normal (ULN), serum aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) ≤2.5 times ULN
• Signed informed consent, and the patient voluntarily accepts treatment according to this protocol

You may not qualify if:

• Unable to complete baseline assessment
• Individuals with a fear of acupuncture
• Those planning to receive postoperative adjuvant radiotherapy
• History of blood system diseases, organ transplant history, or those requiring long-term oral immunosuppressants
• Individuals with implanted cardiac pacemakers
• Those who have received acupuncture treatment within the past 6 weeks
• Fever within 3 days prior to enrollment with a temperature above 38°C or clinically significant infections(Subject to enrollment once infection is managed)
• Currently receiving or having used the investigational drug or device within 4 weeks prior to the first intervention of the study
• Presence of other primary tumors
• Pregnant or breastfeeding women, individuals with mental illness, intellectual or language disabilities, those lacking legal capacity, or those whose medical or ethical reasons affect the continuation of the study

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (3)

The first affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

Sixth Affiliated Hospital ,Sun Yat-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Recurrence

Interventions

Acupuncture Therapy; Drug Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Haibo Zhang, Prof

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiwu Rao, Dr

CONTACT

86-20-81887233; 18851823395@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 1, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (3)