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NCT04392622
d-Limonene +Radiation +PlatinumBasedChemo for Xerostomia Prevention in LocallyAdvanced HNSCC
Phase 1 trial testing D-Limonene Gelcaps in Xerostomia in 40 participants. Currently enrolling.
15 August 2027
Quick facts
| Lead sponsor | Stanford University |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 40 |
| Start date | 15 February 2021 |
| Primary completion | 15 August 2027 |
| Estimated completion | 15 May 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- D-Limonene Gelcaps — full drug profile →
- Intensity modulated radiotherapy (IMRT)
- Cisplatin (cisplatin) — full drug profile →
- Xerostomia questionnaire
Conditions studied
- Xerostomia — all drugs for Xerostomia →
Sponsor
Stanford University
Who can join
18 and older, any sex, with Xerostomia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Dietary fat and lipid metabolism in the tumor microenvironment.
Goswami S, Zhang Q, Celik CE, Reich EM, et al · · 2023 · cited 21× · PMID 37722512 · DOI 10.1016/j.bbcan.2023.188984 -
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 -
Aldehyde dehydrogenase 3A1 deficiency leads to mitochondrial dysfunction and impacts salivary gland stem cell phenotype.
Viswanathan V, Cao H, Saiki J, Jiang D, et al · · 2022 · cited 6× · PMID 35707206 · DOI 10.1093/pnasnexus/pgac056 -
A Computational Text Mining-Guided Meta-Analysis Approach to Identify Potential Xerostomia Drug Targets.
Beckman MF, Brennan EJ, Igba CK, Brennan MT, et al · · 2022 · cited 4× · PMID 35268532 · DOI 10.3390/jcm11051442
Verify or expand the search:
- PubMed search for NCT04392622
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of D-Limonene Gelcaps
Trials testing the same drug.
- NCT06647095 — New Non-invasive Biomarkers of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) · completed
Other recruiting trials for Xerostomia
Currently open trials in the same condition.
- NCT07394842 — Longitudinal Oral Health Changes After Head and Neck Radiotherapy · active not recruiting
- NCT06465628 — Acupressure on Xerostomia in Head and Neck Cancer Patients · NA · recruiting
- NCT06365047 — Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine · Phase 3 · active not recruiting
- NCT06194123 — Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis · NA · active not recruiting
- NCT06287294 — An Investigation Into Taste Problems Associated With Xerostomia in Patients With Advanced Cancer · recruiting
Other Stanford University trials
Trials by the same sponsor.
- NCT05945147 — Ketamine and Midazolam Infusions for CRPS: Feasibility Study · Phase 2 · withdrawn
- NCT04225949 — Patients Understanding of PROM Graphs · NA · withdrawn
- NCT06273098 — School-Based Bladder Health Intervention · NA · withdrawn
- NCT04652635 — Management of Nailbed Injuries · NA · withdrawn
- NCT05443503 — Stanford Spine Keeper - Managing Your Low Back Pain · NA · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04392622 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stanford University
- Last refreshed: 20 July 2025
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/NCT04392622.
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