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Acupuncture Combined With Chemotherapy for Gastric Cancer After Surgery

ConditionGastric Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangzhou University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture

    Other intervention

    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.

  • Sham Acupuncture

    Other intervention

    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.

  • Chemotherapy

    Drug

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

Treatment groups

346 Participants
are divided into 2 treatment groups
Group A: Acupuncture Treatment GroupExperimental treatment 2 interventions
Group B: Sham Acupuncture GroupSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Disease free survival

Time frame
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

1

Average trajectory of FACT-Gastric TOI over time

FACT-Gastric Scoring is designed for measurement of quality of life(QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING (PWB) SUBSCALE, FUNCTIONAL WELL BEING (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (GaCS) of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life.

Time frame
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
2

Total AUC of FACT-Gastric TOI

FACT-Gastric Scoring is designed for measurement of quality of life(QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING (PWB) SUBSCALE, FUNCTIONAL WELL BEING (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (GaCS) of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life. The area under curve (AUCs) are calculated by linear interpolation respectively, and then added together for the total AUC during the 4 cycles of chemotherapy.

Time frame
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
3

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

The GaCS of FACT-Gastric focuses on the symptoms and functions related to gastric cancer specifically. The range of GaCS is 0-76. The higher the score, the better the quality of life.

Time frame
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
4

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

The GaCS of FACT-Gastric focuses on the symptoms and functions related to gastric cancer specifically. The range of GaCS is 0-76. The higher the score, the better the quality of life. The area under curve (AUCs) are calculated by linear interpolation respectively, and then added together for the total AUC during the 4 cycles of chemotherapy.

Time frame
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

1

Traditional Chinese medicine syndrome data

The scale evaluates symptoms (e.g., fatigue, poor appetite) scored 0-10 per item. Scores are collected by TCM physicians and reported as mean change from baseline

Time frame
Assessed on the last day of each chemotherapy cycle (each cycle is 21 days), up to treatment completion (maximum 8 cycles).
2

Adverse events

Incidence of treatment-related adverse events (TRAEs) graded by CTCAE v5.0

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou University of Traditional Chinese Medicine

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Collaborator

First Affiliated Hospital, Sun Yat-Sen University

Collaborator

Source ClinicalTrials.gov

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