Status:

COMPLETED

Propolis-based Product (FARINGEL PLUS) for Oral Mucositis in Palliative Care

Lead Sponsor:

Campus Bio-Medico University

Conditions:

Oral Mucositis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Oral health is crucial for palliative patients' quality of life. The evidence on effective interventions and measures of oral mucositis in palliative care is sparse. This is a single-center, prospect...

Detailed Description

Palliative Care with has primary objective of the best possible quality of life for patients with advanced illness. Oral health is crucial for quality of life. Oral disorders such as hyposalivation, m...

Eligibility Criteria

Inclusion

  • Patients cared for by specialized palliative care center in hospice or at home
  • Conscious patients able to swallow (score 1-2 at the swallowing item of OAG)
  • Patients with a life expectancy of between one week and one month estimated with the RAD (Approximation of Death Recognition) card in use in the palliative care center where the study will be conducted;
  • Patients who provide consent to participate in the study and use the data independently, or through their legal representative.

Exclusion

  • Patients with a life expectancy of less than one week or more than one month estimated with the RAD (Approximation of Death Recognition) card;
  • Patients who are unable to swallow (score 3 on the swallowing item on the OAG scale)
  • Patients with head / neck cancer or tracheostomy;
  • Patients who report allergy to propolis, honey, aloe, chamomile, calendula, stevia (or other components of the product under study) or atopy.

Key Trial Info

Start Date :

July 13 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 7 2022

Estimated Enrollment :

77 Patients enrolled

Trial Details

Trial ID

NCT04911335

Start Date

July 13 2021

End Date

November 7 2022

Last Update

February 8 2023

Active Locations (1)

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1

Centro di cure palliative Insieme per la cura

Roma, RM, Italy, 00128