Objectives Restriction of raw fruits and vegetables (neutropenic diet) is advised for patients receiving treatment for acute leukaemia in low-income and middle-income countries (LMICs) to reduce infections despite evidence to the contrary from high-income countries. We, therefore, conducted a randomised controlled trial to ascertain the efficacy of the neutropenic diet in an LMIC setting.
Methods Patients aged 1–60 years receiving induction chemotherapy for acute leukaemia were randomised to a regular or neutropenic diet. The study’s primary objective was to compare the incidence of major infections among patients receiving the two diets during induction chemotherapy. The secondary objectives were to compare stool microbial flora and induction mortality rates.
Results We randomised 200 patients, 98 patients to the regular diet arm and 102 to the neutropenic diet arm. Major infections occurred in 32 (32%) patients in the regular diet arm and 26 (25%) patients in the neutropenic diet arm (p=0.26). There were no statistically significant differences between patients receiving a regular diet versus neutropenic diet for blood culture positivity (n=6 vs 9), inotropic support (17 vs 12), mechanical ventilation (8 vs 5), third-line antibiotic use (28 vs 20), minor infections (12 vs 9), induction mortality (9 vs 4) and remission status (94% vs 94%). The stool culture on day 15 of induction grew multidrug-resistant bacteria in 38% of patients in the regular diet arm and 35% in the neutropenic diet arm (p=0.67).
Conclusions A neutropenic diet did not prevent infections, reduce mortality or change stool microbial flora in patients with acute leukaemia.
- Supportive care
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VR and PBBL contributed equally.
Contributors VR, PBBL and VV conceived and designed the study. VR obtained funding for the study. VR, PBBL, VV and DG were involved with data collection. VR, PBBL and SR conducted the data analysis. VR, PBBL, DG, JPK, PG and TSG managed the patients in the trial. VR and PBBL wrote the original draft, which was reviewed and approved by all coauthors. All authors had access to the raw data. VR and PBBL directly accessed and verified the underlying data reported in the manuscript. VR is the guarantor for the study.
Funding Cankids, India (non-government organisation)
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.
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