Randomized Comparison of Cooked and Noncooked Diets in Patients Undergoing Remission Induction Therapy for Acute Myeloid Leukemia
- Study type
- Clinical trial
- Design
- Two-arm randomised trial (cooked versus raw diet) stratified by early mortality risk score
- Sample size
- 153 patients
- Source
- JCO · 2008
In plain words
In this study, patients with acute myeloid leukaemia who were staying in a special room with filtered air were randomly given either fully cooked food or food that included fresh fruit and vegetables. Rates of serious infection and death did not differ meaningfully between the two groups. So in this setting, avoiding raw fruit and vegetables did not reduce serious infection or death. Discuss decisions about your diet with your treatment team.
Key results
Treatment arms and regimens
Dietary intervention without drugs: diet without raw fruit and vegetables (cooked diet) from admission to the HEPA-filtered room until discharge from the protected environment (78 patients). All patients received antibacterial and antifungal prophylaxis; the type and dose of prophylactic drugs and the induction chemotherapy regimen (reported as similar in the two groups) are not given in the abstract, and the full text was not available to us.
Dietary intervention without drugs: diet including fresh fruit and vegetables (raw diet) with the same admission conditions and antibacterial and antifungal prophylaxis (75 patients).
Source of the regimen details: Dietary intervention (no drug); abstract of the paper (PMC4879706); the type and dose of prophylactic drugs and induction chemotherapy are not given in the available sources
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with newly diagnosed acute myeloid leukaemia (AML) admitted for induction therapy to a HEPA-filtered room (protected environment, PE). Randomisation was stratified by early risk of mortality (ERM) score.
Endpoints
Main outcomes of interest: major infection (pneumonia, bacteraemia or fungaemia) and death. Under the design assumption, if the true probability of each of these events were 20% in the cooked group and 40% in the raw group, the probability of selecting the cooked group as superior would be 83%.
Safety and side effects
No separate data on grade ≥3 adverse events are reported in the abstract. Fever of unknown origin occurred in 51% of the cooked group and 36% of the raw group.
Clinical significance and place in guidelines
This trial showed that a neutropenic diet (no raw fruit and vegetables) gives no advantage in preventing major infection or death in AML patients treated in a HEPA-filtered protected environment with antibacterial and antifungal prophylaxis. This finding is limited to these conditions; the status of current formal recommendations should be checked in up-to-date guidelines.
Limitations
According to the abstract, the results relate to patients treated in a protected environment with antimicrobial prophylaxis and may not be generalisable to other settings. Further details on limitations are in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.