Restrictive diet an 'unnecessary burden' for patients undergoing HSCT
Click Here to Manage Email Alerts
NEW ORLEANS — Adults undergoing stem cell transplant who received a nonrestrictive diet had similar rates of infection, feeding outcomes and acute graft-versus-host disease as those on a low-microbial protective diet, according to a study.
“The results of this ... the first randomized study investigating the role of diet after allogeneic and autologous stem cell transplantation, demonstrate that the use of a restrictive diet is an unnecessary burden for the patients’ quality of life,” Federico Stella, MD, of Università degli Studi di Milano - Istituto Nazionale dei Tumori in Milan, said during a press conference at ASH Annual Meeting and Exposition.
Background
Infections are a leading cause of morbidity and mortality among patients with neutropenia following receipt of high-dose chemotherapy, particularly following hematopoietic stem cell transplantation, according to study background.
About 90% of bone marrow transplantation centers prescribe a low-microbial protective diet for patients undergoing HSCT, in an effort to prevent infections. These diets allow only foods that have been cooked to about 175 degrees Fahrenheit and prohibit fresh fruits and vegetables.
Despite its widespread use, the protective diet had not been tested prospectively in a randomized controlled trial.
Methodology
The multicenter, noninferiority randomized phase 3 trial included 224 adults (median age, 56 years; 57% men) undergoing HSCT who had been randomly assigned 1:1 to a protective diet or a nonrestrictive diet of standard hospital fare, which could include fresh fruits and vegetables, cold cuts, pasteurized honey and yogurt.
Patients in the groups had similar baseline characteristics. Disease types included multiple myeloma (38%), lymphomas (37%) and acute myeloid leukemia (5%). Most patients (76%) received autologous HSCT, whereas 21% received allogeneic HSCT and 6% underwent high-dose induction chemotherapy.
Study participants remained on their assigned diet from the start of chemotherapy through the duration of neutropenia. Follow-up occurred 100 days after receipt of allogeneic transplants and 30 days after receipt of autologous transplants or high-dose chemotherapy.
Key findings
Results showed no difference between the groups in cumulative rates of infections, including grade 2 or greater infections (protective diet, 34%; nonrestrictive diet, 39%; RR = 0.86; 95% CI, 0.6-1.2). Researchers also reported similar rates in the protective vs. nonrestrictive diet groups of the following:
- fever of unknown origin, including febrile neutropenia (43% vs. 39%; RR = 1.3; 95% CI, 0.9-1.7);
- sepsis (11% vs. 14%; RR = 0.7; 95% CI, 0.4-1.5);
- documented gastrointestinal infection (7% vs. 3%; RR = 2.7; 95% CI, 0.8-9.1);
- microbiological isolation (30% vs. 34%; RR = 0.9; 95% CI, 0.6-1.3);
- any-grade acute GVHD (30% vs. 33%; RR = 0.9; 95% CI, 0.4-2.1);
- intestinal acute GVHD (13% vs. 8%; RR = 1.6; 95% CI, 0.3-7.4); and
- grade 2 or higher acute GVHD among allogeneic HSCT recipients (17% vs. 25%; RR = 0.7; 95% CI, 0.2-2).
The groups had similar body weight variations (mean, 3.6 kg vs. 3.2 kg), rates of nausea (16% vs. 15%; RR = 1.1, 95% CI, 0.6-1.9) and mucositis (62% vs. 60%; RR = 1.05, 95% CI, 0.8-1.3), length of hospitalization (mean 21 days vs. 22 days), parenteral nutrition use (23% vs. 26%; RR = 0.9; 95% CI, 0.4-1.4) and duration of parenteral nutrition (mean, 6.9 days vs 6.7 days).
One patient death had been reported at 30 days. A patient in the nonrestrictive diet group who underwent allogeneic HSCT for a myeloproliferative neoplasm died of cytokine release syndrome after suspension of ruxolitinib (Jakafi, Incyte).
Patients in the nonrestrictive diet group expressed higher satisfaction. More than twice as many patients in the nonrestrictive vs. protective diet group agreed that the prescribed diet “did not negatively impact my alimentation” (35% vs. 16%; RR = 0.5; 95% CI, 0.3-0.8).
Perspective
Back to Top
Mikkael A. Sekeres, MD, MS
For decades, patients have been placed on neutropenic diets that avoid things that may be associated with infections. I jokingly referred to it as “gruel” during the press conference, and patients hate it because they tend to be bland, unexciting meals. I’ve always thought it’s bad enough that we have patients in the hospital for 4 to 6 weeks, now we have to give them food that’s completely unappetizing.
I eliminated the neutropenic diet for my patients with leukemia years ago. I’ve been practicing for 20 years taking care of patients with acute leukemia, who are hospitalized just like the patients in this study, and I have never seen a patient who has gotten seriously ill or died of a foodborne infection. This study was the first to formally look at it in a randomized fashion.
Stella and colleagues randomly assigned 234 patients to a nonrestrictive diet, meaning they could eat whatever they wanted, or what the authors referred to as a “protective diet.” And that has long been the philosophy of putting patients on this diet — that we're protecting them from infections and, in the case of patients undergoing bone marrow transplant, potentially protecting them from developing graft-versus-host disease of the bowel.
The authors followed them for a couple of months afterward and found no difference in incidence of infections between the two groups, no incidence of severe infection in the form of sepsis between the two groups, no difference in GI infection, no difference in GVHD and no difference in survival or early death — absolutely no beneficial, or “protective,” effects of placing patients on a restricted diet, or what we call a “neutropenic diet.”
I'm so excited about this study because it truly changes practice. I think the take-home message is we should do away with these neutropenic diets, allow patients to eat what they want within reason, and put this into place in transplant units and leukemia units around the world.
Collapse
Stella F, et al. Abstract 169. Presented at: ASH Annual Meeting and Exposition; Dec. 10-13, 2022; New Orleans.
Click Here to Manage Email Alerts