Abstract 1843P
Background
Gastrectomy followed by adjuvant chemotherapy (chemo) remains preferred strategy for local gastric cancer. However, quality of life (QoL) declines post-operatively, due to both surgery and chemotherapy. This pilot study (NCT03753399) aimed at evaluating the preliminary effect of electro-acupuncture (EA) for improving quality of life in gastric cancer patients undergoing adjuvant chemotherapy.
Methods
Patients who has accepted R0 resection for gastric cancer, and who will receive adjuvant chemotherapy were randomly assigned to receive high-dose of EA (7 times each chemo-cycle for 3 cycles), low-dose of EA (3 times each chemo-cycle for 3 cycles), or no acupuncture. Functional Assessment of Cancer Therapy-Gastric (FACT-Ga) was reported by the patients at baseline and then once a week during the therapy. Primary endpoint was the total area under curves (AUCs) of FACT-Ga Trial Outcome Index (TOI) during the 3 cycles of chemotherapy, calculated by linear interpolation, among the groups. Secondary endpoints included the AUCs of FACT-Ga Gastric Cancer Subscale (GaCS), and FACT-Ga score among the groups.
Results
Of the randomized 66 patients, 45 (68.18%) were analyzed in the per-protocol set (PPS). Electro-acupuncture, both high-dose and low-dose, although not significantly, produced trend of QoL improvement. AUCs (21 days/cycle × 3 cycles), the higher, the better, of TOI in the PPS were 5360±1120, 5443±1313, and 4780±840 (p=0.188), of GaCS were 3273±591, 3261±757, and 2865±534 (p=0.126), and of FACT-Ga were 7731±1587, 7979±1702, and 7084 ±1183 (p=0.231), in high-dose EA group, low-dose EA group, and control group, respectively. When combining patients in the two EA groups, TOI (5402±1198 vs. 4780±840, p=0.048) and GaCS (3267±666 vs. 2865±534, p=0.041) AUCs of EA patients were significantly higher than those in control group. AUCs of FACT-Ga in EA patients were also higher than those in control group, although the difference was not statistically significant (7855±1620 vs. 7085±1183, p=0.074).
Conclusions
Electro-acupuncture was associated with promising effect in improving quality of life during adjuvant chemotherapy in gastric cancer patients. Future adequately powered trial is needed to confirm the specific effect.
Clinical trial identification
NCT03753399 first release: November 27, 2018.
Editorial acknowledgement
Legal entity responsible for the study
Hai-bo Zhang.
Funding
The National Key Research and Development Program of China (2017YFC1700603); The Science and Technology Planning Project of Guangdong Province (2017A020213021).
Disclosure
All authors have declared no conflicts of interest.