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NCT04562922: LEO
LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy
Phase 2 trial testing Lifemel in Neutropenia in 39 participants. Completed in 4 April 2016.
26 May 2014
Quick facts
| Lead sponsor | VitalMel |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 39 |
| Start date | 11 November 2013 |
| Primary completion | 26 May 2014 |
| Estimated completion | 4 April 2016 |
Drugs / interventions tested
- Lifemel
Conditions studied
- Neutropenia — all drugs for Neutropenia →
- Adverse Event — all drugs for Adverse Event →
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):
-
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
Verify or expand the search:
- PubMed search for NCT04562922
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04562922 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by VitalMel
- Last refreshed: 24 September 2020
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing