Clinical TrialID 868

The Effectiveness of a Thyme and Honey Spray for Oral Toxicities

NCT04880148

Cancer of the Head and Neck|Xerostomia|Oral Mucositis|Radiation Toxicity

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Record Fields

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Clinical Trial Id
868
Evidence Id
868
Core Evidence Id
868
Source Clinical Trial Id
850
Herb2 Clinical Trial Id
HBCT000850
Nct Id
NCT04880148
Title
The Effectiveness of a Thyme and Honey Spray for Oral Toxicities
Status
Phase
Study Result
No
Study Condition
Cancer of the Head and Neck|Xerostomia|Oral Mucositis|Radiation Toxicity
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Intervention
DIETARY_SUPPLEMENT: Thyme and Honey-based oral spray|DIETARY_SUPPLEMENT: Placebo oral spray
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Supportive_Care
Gender
All
Age
Adult, Older_Adult
Enrollment
200
Outcome Measure
Change from baseline in Mucositis Grade (RTOG) at weekly assessments, The scale includes 5 grades (from 0 to IV). Higher grade denotes more severe mucositis, Baseline (week 4), week 5, week 6, week 7, week 8 and week 24|Change from baseline in Xerostomia Grade (CTCAE) at weekly assessments, he scale includes 5 grades (from 0 to IV). Higher grade denotes more severe xerostomia, Baseline (week 4), week 5, week 6, week 7, week 8 and week 24
Sponsor Collaborator
Cyprus University of Technology|German Oncology Center, Cyprus|Bank of Cyprus Oncology Center BOCOC
Funded By
OTHER
Location
German Oncology Center, Limassol, 4108, Cyprus|Bank of Cyprus Oncology Center, Nicosia, 2006, Cyprus
Other Id
21-HONEY-CUT
Start Date
2021-11-03
Primary Completion Date
2024-06-01
Completion Date
2024-09-01
First Posted
2021-05-10
Results First Posted
Last Update Posted
2021-12-09
Study Document
Study Url
https://clinicaltrials.gov/study/NCT04880148
Title Cn
Title En
The Effectiveness of a Thyme and Honey Spray for Oral Toxicities
Bilingual Status
semi_complete