- 2026-06-01
- Asia Pacific journal of clinical nutrition 35(3)
- Jianchun Yu
- Wei Chen
- Gang Xiao
- Qi An
- Ziyu Li
- Bin Liang
- Yuanxin Li
- Dongbing Zhao
- Junsheng Peng
- Yanbing Zhou
- Guole Lin
- Weiming Kang
- Zijian Li
- Chao Yan
- Yuanpei Lin
- Changzhen Zhu
- Hu Ren
- Yijia Lin
- Yulong Tian
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 325
- Population
- patients with gastrointestinal tumors scheduled for surgery and at high risk for malnutrition
- Methods
- multicenter, randomized, open-label, non-inferiority phase III trial, randomized 1:1 to receive either FSMP or TPF-T as a sole nutritional source from 4±2 days before surgery to 9±3 days postoperatively
- Blinding
- Open-label
- Duration
- 4±2 days before surgery to 9±3 days postoperatively
- Funding
- Unclear
Background and objectives
This study aimed to evaluate the safety and efficacy of a fish oil-enriched food for special medical purposes (FSMP, ProSure) compared to an oncology-specific enteral nutrition product (TPF-T).Methods and study design
This multicenter, randomized, open-label, non-inferiority phase III trial (NCT05301556) included patients with gastrointestinal tumors scheduled for surgery and at high risk for malnutrition. Participants were randomized 1:1 to receive either FSMP or TPF-T as a sole nutritional source from 4±2 days before surgery to 9±3 days postoperatively. The primary endpoint was the change in serum pre-albumin levels from baseline to 9±3 days post-surgery (non-inferiority margin: 20.807 mg/L).Results
Of the 325 patients randomized (FSMP: n = 162; TPF-T: n = 163), FSMP demonstrated non-inferiority to TPF-T in maintaining serum pre-albumin levels in the perioperative patients (least square [LS] mean differ-ence: 6.9 mg/L, 95% CI: -5.0 to 18.8). FSMP showed a greater reduction in serum triglycerides (LS mean difference: -0.133 mmol/L, 95% CI: -0.239 to -0.027, p = 0.014), while comparable changes in other lipid parameters, serum albumin, body weight, or grip strength from baseline to 9±3 days post-surgery, and the length of hospital stay were observed between groups (all p >0.05). The most common treatment-emergent adverse events were gastrointestinal disorders, including abdominal distension (FSMP: 17.3% vs. TPF-T: 18.4%), di-arrhea (21.0% vs. 11.0%), and nausea (6.8% vs. 5.5%).Conclusions
ProSure, an FSMP, when used as a sole nutritional source, is not inferior to TPF-T in maintaining perioperative nutritional status in patients with gastrointestinal tumors, demonstrating comparable efficacy and safety.