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NCT04880148: HONEY

The Effectiveness of a Thyme and Honey Spray for Oral Toxicities

Status unknown NA Last updated 9 December 2021
What this trial tests

NA trial testing Thyme and Honey-based oral spray in Cancer of the Head and Neck in 200 participants. Status unknown.

Timeline
3 November 2021
Primary endpoint
1 June 2024
1 September 2024

Quick facts

Lead sponsorCyprus University of Technology
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposesupportive care
Enrollment200
Start date3 November 2021
Primary completion1 June 2024
Estimated completion1 September 2024
Sites2 locations across Cyprus

Drugs / interventions tested

Conditions studied

Sponsor

Cyprus University of Technology

Who can join

18 and older, any sex, with Cancer of the Head and Neck or Xerostomia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Aim: To evaluate the effectiveness of thymus honey on radiation induced-oral mucositis and xerostomia. Background: Oral mucositis and xerostomia are two of the most severe side effects that head and neck cancer patients confront during and after the completion of radiotherapy. Although several medications are used for their treatment, these fail to provide a fully effective and comprehensive management. Honey and thyme have been studied for the management of various treatment-related side effects. Design: Α double blinded randomised controlled trial will be used for this study. Methods: 200 head and neck cancer patients who receive radiotherapy will be included in this study. Patients will be randomised and divided into two equal groups of 100 participants; the intervention group (oral spray with thyme and honey + standard care) and the control group ( placebo spray + standard care). Assessments with xerostomia and oral mucositis scales additionally to 4 self-administered questionnaires will occur in both groups at baseline and then weekly and 6 months following completion of treatment. The duration of the study will be 3 years from the day of approval of this research protocol.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Salivary toxicity from PSMA-targeted radiopharmaceuticals: What we have learned and where we are going.
    Muniz M, Loprinzi CL, Orme JJ, Koch RM, et al · · 2024 · cited 17× · PMID 38703593 · DOI 10.1016/j.ctrv.2024.102748
  2. Cancer treatment-related xerostomia: basics, therapeutics, and future perspectives.
    Hosseini MS, Sanaie S, Mahmoodpoor A, Jabbari Beyrami S, et al · · 2024 · cited 12× · PMID 39614391 · DOI 10.1186/s40001-024-02167-x

Verify or expand the search:

Other recruiting trials for Cancer of the Head and Neck

Currently open trials in the same condition.

Other Cyprus University of Technology trials

Trials by the same sponsor.

Verify against primary sources

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/NCT04880148.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing