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NCT04562922: LEO

LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy

Completed Phase 2 Last updated 24 September 2020
What this trial tests

Phase 2 trial testing Lifemel in Neutropenia in 39 participants. Completed in 4 April 2016.

Timeline
11 November 2013
Primary endpoint
26 May 2014
4 April 2016

Quick facts

Lead sponsorVitalMel
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment39
Start date11 November 2013
Primary completion26 May 2014
Estimated completion4 April 2016

Drugs / interventions tested

Conditions studied

Sponsor

VitalMel

Who can join

18 and older, any sex, with Neutropenia or Adverse Event. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

LEO trial was designed to assess the benefit of administering LifeMel to prevent myelotoxicity in patients affected by solid neoplasm undergoing antiblastic chemotherapy treatment at low to moderate risk of febrile neutropenia. Secondary endpoints of LEO trial were assessing impact of LifeMel in preventing anaemia and thrombocytopenia.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Simon's two-stage design trial evaluating the potential role of a kind of honey in preventing chemotherapy-hematopoietic toxicities.
    Sponghini AP, Rondonotti D, Platini F, Cena T, et al · · 2021 · cited 2× · PMID 34522641 · DOI 10.1016/j.jtcme.2021.04.005

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Other recruiting trials for Neutropenia

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04562922.

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