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HIGH TOLERABILITY OF THE SURGICAL NUTRITIONAL AND EXERCISE TREATMENT FOR ADVANCED CANCER PROGRAM IN PERIOPERATIVE ELDERLY PATIENTS UNDERGOING GASTRECTOMY FOR GASTRIC CANCER: SNEXTAC-GC ONE TRIAL
Keiichi Fujiya
*1, Tateaki Naito
1, Kenta Murotani
2, Miho Naito
3, Yusuke Koseki
1, Kenichiro Furukawa
1, Yutaka Tanizawa
1, Masanori Terashima
1, Hiroshi Fuseya
1, Kentaro Yamazaki
1, Etsuro Bando
11Gastric surgery, Shizuoka Kenritsu Shizuoka Gan Center, Sunto-gun, Shizuoka, Japan; 2Kurume Daigaku, Kurume, Fukuoka, Japan; 3Kurume Daigaku Byoin, Kurume, Fukuoka, Japan
BackgroundDespite many clinical trials, the efficacy of perioperative nutrition and exercise therapy for gastric cancer remains unestablished, particularly in elderly patients, for whom studies on safety and tolerability are extremely limited. This study aimed to develop and assess the safety and tolerability of the surgical Nutritional and EXercise Treatment for Advanced Cancer (sNEXTAC) program in perioperative elderly patients undergoing gastrectomy for gastric cancer.
MethodsThis single-center, single-arm, prospective trial (jRCTs041210144) included patients aged ?65 years scheduled for gastrectomy for cancer. The sNEXTAC program involves a multidisciplinary team providing 10 intervention sessions during the perioperative period for gastric cancer, with patients engaging in nutrition and exercise therapy over 3 weeks preoperatively and 12 weeks postoperatively through a home-based program. The primary endpoint was attendance rate in the sNEXTAC program, which included 1 exercise and 1 nutritional session preoperatively, and 4 exercise and 4 nutritional sessions postoperatively. The planned sample size was 30, with one-sided alpha of 10%, power of 70%, expected attendance rate of 70%, and threshold of 50%. The exercise interventions involved home-based resistance training and counseling to promote physical activity using an active tracker, while the nutritional interventions focused on educating patients on post-gastrectomy dietary methods, managing symptoms affecting food intake, and administering a high-density liquid diet (100mL, 400 kcal/day).
ResultsFrom January to November 2023, 30 patients were enrolled. The median age was 74 years (range: 66–87), with 21 men and 9 women. The median BMI was 22.8. Comorbidities were present in 25 patients. Distal gastrectomy was performed in 22 patients, total gastrectomy in 7, and proximal gastrectomy in 1 for cStage I/II/III gastric cancer (22/4/4) patients. Postoperative complications occurred in 5 patients, including abscess in 3, bowel obstruction in 1, and a cerebrovascular infarction in 1. The overall program attendance rate was 98.7%, with 29 patients completing all 10 sessions, while 1 patient discontinued postoperatively due to a hematologic malignancy. The median intervention period was 27 days preoperatively and 87 days postoperatively. Adverse events possibly related to the sNEXTAC program were observed in 5 patients, including two with abdominal distention, and one each with gastroparesis, anorexia, and diarrhea (all grade 1).
ConclusionsOur perioperative multimodal nutrition and exercise interventions demonstrated excellent safety and tolerability in elderly gastric cancer patients. A randomized control study is planned to assess the efficacy of the sNEXTAC program in this patient population.
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