Efficacy of ready‐to‐use therapeutic food in malnourished children with cancer: Results of a randomized, open‐label phase 3 trial Academic Article uri icon

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abstract

  • BACKGROUND: The adverse influence of undernutrition in children with cancer may be remediated by early nutritional intervention. This study assessed the efficacy of ready-to-use therapeutic food (RUTF) in improving nutritional status and reducing treatment-related toxicities (TRTs) in such children. METHODS: In a randomized controlled phase-3 open-label trial, severely and moderately undernourished children with cancer were randomized 1:1 to receive standard nutritional therapy (SNT) or SNT+RUTF for 6 weeks. The primary outcome (weight gain >10%) and secondary outcomes (improved/maintained nutritional status, improved body composition) were assessed after 6 weeks. TRTs were assessed over 6 months. RESULTS: Between July 2015 and March 2018, 260 subjects were enrolled, 126 were analyzable in both arms at 6 weeks. More children on RUTF had weight gain (98 [77.8%] vs. 81 [64.2%], p = .025) with a greater increase in fat mass as a percentage of body mass (median 2% [IQR -0.12 to 4.9] vs. 0.5% [IQR -1.45 to 2.27, p = .005]) but a greater loss of lean mass (median -1.86% [IQR -4.4 to 0.50] vs. -0.4% [IQR -2.4 to 1.4, p = .007]) compared to the SNT arm. Fewer subjects on the RUTF arm had episodes of severe infection (10.6% vs. 31%, p < .0001), treatment delays (17.7% vs. 39%, p < .0001), and severe mucositis (11% vs. 23.8%, p = .006) compared to the SNT arm. The odds of developing TRTs on the RUTF arm were lower even after adjusting for improvement in nutritional status. CONCLUSIONS: RUTF is efficacious in improving weight gain and nutritional status in undernourished children with cancer and decreases TRTs. Incorporating RUTF into a healthy, balanced diet should be considered in undernourished children with cancer.

authors

  • Prasad, Maya
  • Tandon, Sneha
  • Gala, Rajul
  • Kannan, Sadhna
  • Chinnaswamy, Girish
  • Narula, Gaurav
  • Vora, Tushar
  • Banavali, Shripad
  • Mehta, Shaesta
  • Paradkar, Amey
  • Goswami, Savita
  • Ghadge, Meera
  • Jagiasi, Deepak
  • Sharma, Sujata
  • Fernandes, Lavina
  • Manglani, Mamta
  • Jadhav, Alka
  • Barr, Ronald Duncan
  • Ladas, Elena

publication date

  • September 2021