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NCT02608879 · ClinicalTrials.gov registry record · NA
Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT02608879: Completed NA study, sponsored by NYU Langone Health.
NCT02608879 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02608879, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effects of a novel oral care protocol on the severity and pain of oral mucositis in patients receiving radiation and/or chemotherapy for head and neck cancers. The secondary objectives are to characterize the microbiome associated with oral mucositis, measure salivary proinflammatory cytokines, and evaluate other clinical indicators of the intervention. Participants will be enrolled prior to beginning radiation and/or chemotherapy, and will be randomized to receive either the oral health protocol or standard of care oral hygiene.
Primary Outcome
OM severity will be assessed by the WHO Oral Mucositis Scale at each follow-up visit. The WHO Oral Mucositis Scale is a 5 point scale (0 to 4) with the following scoring system: 0=None 1. Soreness with erythema 2. Erythema, ulcers, can eat solids 3. Ulcers, liquid diet only 4. Alimentation not possible
Interventions
- OTHER Chlorhexidine
- PROCEDURE Oral Mucosa Deterging and Periodontal Debridement (OMDP)
- PROCEDURE Standard of Care Oral Hygiene Instructions
- PROCEDURE Dental scaling, ultrasonic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-09 |
| Phase | NA |
What the finished NCT02608879 record still lists
NCT02608879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 4 interventions - of which Chlorhexidine is the first listed.
NCT02608879 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02608879 about?
NCT02608879 is a clinical study titled "Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis". The purpose of this study is to determine the effects of a novel oral care protocol on the severity and pain of oral mucositis in patients receiving radiation and/or chemotherapy for head and neck cancers. The secondary objectives are to characterize the microbiome associated with oral mucositis, me...
What is the current status of trial NCT02608879?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2014-03. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02608879?
The interventions under investigation include: Chlorhexidine (OTHER), Oral Mucosa Deterging and Periodontal Debridement (OMDP) (PROCEDURE), Standard of Care Oral Hygiene Instructions (PROCEDURE), Dental scaling, ultrasonic (PROCEDURE).
Who is sponsoring clinical trial NCT02608879?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02608879's enrollment target sits among peer trials
19 1861st of 2000 higher than 138 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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