Phase 3 Data Support Leaving the “Neutrodiet” Behind After Stem Cell Transplant

An unrestricted diet did not increase infection rates, mortality, malnutrition, or the incidence of acute graft-versus-host disease (GVHD) in patients who experienced neutropenia after stem cell transplantation. American Society of Hematology Annual Meeting and ExpositionThe researchers noted that these findings meant that dietary restrictions were an unnecessary burden on patients’ quality of life.¹

There was no difference in infection between the two groups. The number of grade 2 or less infections reported on the protective diet (n = 117) was 72 (65%) compared to 69 (62%) on the unrestricted diet (n = 113; RR, 1.0). 95% CI, 0.81.3; P. = .80). The incidence of severe infections (defined as grade 3 or greater), fever of unknown origin, sepsis, and pneumonia was judged by the investigators to be balanced.

Microbiological isolation results showed that in both arms, the most frequently isolated bacteria in blood and stool cultures were Enterobacteriaceae. That’s hardProphylactic fluroquinolone reduced bloodstream infection rates (RR, 0.2; 95% CI, 0.001-0.600; P. = .002) but did not prevent severe infection (RR, 1.1; 95% CI, 0.8–1.4; P. = .07).1

More patients in the nonrestrictive diet group maintained their weight one month after ASCT than in the protective diet group (mean change, -2.7 kg vs. -3.7 kg; P. = .04). There were no differences between the two arms with respect to parenteral nutrition use and days, and variability in serum albumin and body mass index.

Additionally, 35% of patients in the no-restrictions group stated that their dietary prescriptions had not adversely affected my nutrition. Only 16% of patients in the protective diet group agreed with the same statement (RR, 0.5; 95% CI, 0.3-0.8; P. = .006), indicating that a nonrestrictive diet correlates with higher patient satisfaction.

Finally, the incidence of grade 3 or greater acute GVHD was comparable between the two arms. Twenty percent of patients in the protective diet group experienced this toxicity compared to 9.5% of patients in the nonrestrictive diet group (RR, 2.1; 95% CI, 0.5-9.1; P. = .40).1

One death was reported in the non-restricted diet group.

“Infection rates, mortality, nutritional outcomes, and acute GVHD incidence did not differ between patients on protective and nonrestrictive diets during neutropenia. said Federico Stella, MD, of the University of Milan, in a presentation of the findings. “The results of this randomized study showed that restricted diet use is an unnecessary burden on patients’ quality of life.”

Infections after stem cell transplantation are a major cause of morbidity and mortality. Due to infection centers, 93% of bone marrow transplant centers implement dietary restrictions. Some medical experts have argued that a non-restrictive diet should be standard practice since 2008.² According to Stella, evidence-based results regarding the effectiveness of restricted diets are lacking.^1,3,4

This study was designed to assess the risk of infection in patients on an ad libitum diet compared to a protective diet following autologous or allogeneic stem cell transplantation.¹

Patients undergoing allogeneic stem cell transplantation (both myeloablative and reduced-intensity) or autologous stem cell transplantation (myeloablative), high-dose chemotherapy, and 7 days or more of neutropenia were included in this trial. Exclusion criteria included active infections prior to neutropenia, inability to take food orally, and having stem cells for a non-neoplastic hematological disorder. receiving, needing to have a second allogeneic stem cell transplant, or needing a cord blood or heterogeneous identity transplant. donor. ¹

A total of 247 patients were enrolled and randomly assigned 1:1 to either a protected diet (n = 117) or an unrestricted diet (n = 113). The protective diet included foods cooked above 80°C and/or thick-skinned fruits. Yogurt, honey, cold cuts, sausages, raw fish and meat, raw vegetables and fruits were all prohibited. It was done. ¹

In contrast, the non-restrictive diet prohibited only raw fish and meat. All other foods were allowed as long as they adhered to hospital hygiene standards.^.1

The primary endpoint of the study was to demonstrate no significant difference between the two study arms in grade 2 or greater infections and death during neutropenia. Secondary endpoints included the incidence of gastrointestinal infections and fever of unknown etiology, the cumulative incidence of overall survival and acute GVHD at 30 days, and the patient’s nutritional status, defined as weight change and length of hospital stay. was included.

According to Stella, patient demographics were balanced in gender, age, disease type, transplant type, previous lines of therapy, disease status at enrollment, and antibiotic prophylaxis. Half (43%) were female, and the median age of study participants was 56 years (range, 22-72 years). Lymphoma was the most common malignancy among patients (47%), followed by multiple myeloma (40%), acute myeloid leukemia (4%) and other diseases (9%).

Overall, 175 patients (79%) underwent autologous stem cell transplantation. Forty-one patients received allogeneic (18%) treatment, of which 20 hers and 21 hers, respectively, included the unrestricted protective cohorts.

On the protective diet, 5 patients were lost to follow-up and 1 patient was withdrawn. In the non-restricted diet group, 1 patient was lost to follow-up and 1 withdrew consent. A total of 111 patients remain in study follow-up in both arms.

References

1. Stella F, Marasco V, Revati G, et al. An unrestricted diet does not increase infections in neutropenic patients after stem cell transplantation: a final analysis of the NEUTRODIET multicenter randomized trial.blood. 2022;140(suppl 1):417-419.doi:10.1182/blood-2022-158662
2. Gardner A, Mattiuzzi G, Faderl S, et al. A randomized comparison of cooked and uncooked meals in patients undergoing induction therapy for acute myeloid leukemia. J Clin On Call2008;26(35):5684-5688. doi:10.1200/JCO.2008.16.4681
3. Peric Z, Botti S, Stringer J, et al. Variability of nutritional practice in the peritransplant period after allogeneic hematopoietic stem cell transplantation: a task force investigation of complications and quality of life in EBMT. Bone marrow transplantation2018;53(8):1030-1037. doi:10.1038/s41409-018-0137-1
4. Trifilio S, Helenowski I, Giel M, et al. Questions about the role of a neutropenic diet after hematopoietic stem cell transplantation. Biol Blood Bone Marrow Transplant2012;18(9):1385-1390. doi:10.1016/j.bbmt.2012.02.015