Impact of cancer-specific foods for special medical purposes on nutritional adequacy, safety, and efficacy in postoperative cancer patients
10.3760/cma.j.cn115822-20250612-00111
- VernacularTitle:肿瘤专用型FSMP对肿瘤术后患者营养充足性、安全性和有效性的影响
- Author:
Fang WANG
1
;
Pengju LIU
1
;
Rongrong LI
1
;
Jin FU
1
;
Wei WEI
1
;
Kang YU
1
Author Information
1. 中国医学科学院 北京协和医学院 北京协和医院临床营养科，北京 100730
- Publication Type:Journal Article
- Keywords:
Nutritional risk;
Nutrition support after surgery;
Cancer;
Foods for Special Medical Purposes
- From:
Chinese Journal of Clinical Nutrition
2025;33(4):266-274
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the impact of a high-energy-density, high-protein, immune-modulating, cancer-specific foods for special medical purposes (FSMP) on nutritional adequacy, safety, and efficacy in postoperative cancer patients.Methods:This multicenter randomized controlled trial enrolled patients with gastrointestinal or head and neck cancer scheduled for surgery and at nutritional risk. Participants were randomized 1∶1 to receive either the investigational cancer-specific FSMP (FSMP group) or a commercially available tumor-specific enteral nutrition (EN) formula (control group). The "nutritional transition phase" (postoperative days 0-3) provided the assigned EN, with energy deficits supplemented by parenteral nutrition (PN). This was followed by the "full EN phase" (intervention period: 10±3 days), with a target energy intake of 105-146 kJ/kg/day. Nutritional adequacy was considered achieved if the actual intake reached ≥80% of the target in both phases. The primary outcomes were the body weight and prealbumin improvement rates after intervention , and the secondary outcomes were the improvement rates of handgrip strength, gait speed, serum albumin, and hemoglobin. Non-inferiority was tested using the confidence intervals, with the least squares mean difference and its 95% CI derived from a Logistic regression model (non-inferiority margin: -0.12).Results:A total of 220 patients from 17 centers completed the study (FSMP group: n=109; control group: n=111). After the nutrition support, the weight loss was (-0.9±2.1) kg and (-1.3±1.8) kg in the FSMP and control groups ( P=0.162), whereas prealbumin increased in both groups (59.0±69.0 mg/L vs. 50.0±62.0 mg/L, P=0.418). The lower bounds of the 95% CIs were -0.08 for both weight and prealbumin improvement rates, exceeding the predefined non-inferiority margin (-0.12). No significant differences were observed in the improvements in albumin, hemoglobin, handgrip strength, or gait speed (all P>0.05). No serious adverse events related to the formulas occurred. The FSMP group had a higher incidence of diarrhea (31.9% vs. 17.8%) and lower compliance rate (<80% intake: 13.4% vs. 5.9%), but the percentages of total energy intake over the estimated energy requirements (% of target) were comparable (89.9%±24.5% vs. 94.0%±22.3%, P=0.310). Conclusions:The cancer-specific FSMP can improve postoperative nutritional status in cancer patients, demonstrating non-inferiority to existing tumor-specific EN formulas in terms of nutritional adequacy, safety, and efficacy.
