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NCT04392622 · ClinicalTrials.gov registry record · Phase 1
d-Limonene +Radiation +PlatinumBasedChemo for Xerostomia Prevention in LocallyAdvanced HNSCC
A Phase 1 study of Xerostomia, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04392622: Recruiting Phase 1 study of Xerostomia, sponsored by Stanford University.
NCT04392622 is a Phase 1 study of Xerostomia that is actively recruiting participants, run by Stanford University. The registered enrollment target is 40 participants, below the 92-participant average among 13 other Xerostomia trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04392622, a Phase 1 study of Xerostomia, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This study explores the safety of d-limonene, a commercially-available dietary supplement (food) as a potential therapeutic for the severe dry mouth (xerostomia) experienced by patients with head and neck cancer as a side effect of their anti-cancer treatment.
Primary Outcome
Dose limiting toxicity is defined as d-limonene related toxicity causing: * Greater than 1 week delay in completing the radiation course. * Inability to receive ≥ 66 Gy of radiotherapy. * Inability to receive at least 200 mg/m2 of total cisplatin equivalent dose or a total area under the curve (AUC) of 10 for carboplatin equivalent dose due to toxicity related to d-limonene Grade 3 or higher diarrhea that is attributable to the study drug. * Grade 3 abdominal pain that is attributable to the st
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG D-Limonene Gelcaps
- RADIATION Intensity modulated radiotherapy (IMRT)
- OTHER Xerostomia questionnaire
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2028-05-15 |
| Phase | Phase 1 |
What NCT04392622 shows while recruiting
NCT04392622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 92-participant average among 13 other Xerostomia trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Xerostomia appearing as the primary indexed condition, and to 4 interventions - of which Cisplatin is the first listed.
NCT04392622 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04392622 about?
NCT04392622 is a clinical study titled "d-Limonene +Radiation +PlatinumBasedChemo for Xerostomia Prevention in LocallyAdvanced HNSCC". This study explores the safety of d-limonene, a commercially-available dietary supplement (food) as a potential therapeutic for the severe dry mouth (xerostomia) experienced by patients with head and neck cancer as a side effect of their anti-cancer treatment.
What is the current status of trial NCT04392622?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2021-02-15. Estimated completion is 2028-05-15.
What conditions does trial NCT04392622 study?
This clinical trial studies the following conditions: Xerostomia.
What interventions are being tested in trial NCT04392622?
The interventions under investigation include: Cisplatin (DRUG), D-Limonene Gelcaps (DRUG), Intensity modulated radiotherapy (IMRT) (RADIATION), Xerostomia questionnaire (OTHER).
Who is sponsoring clinical trial NCT04392622?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04392622 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Xerostomia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04392622's enrollment target sits among peer trials
40 8th of 13 higher than 5 of 13 other Xerostomia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Xerostomia 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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