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NCT04392622

d-Limonene +Radiation +PlatinumBasedChemo for Xerostomia Prevention in LocallyAdvanced HNSCC

Recruiting now Phase 1 Last updated 20 July 2025
What this trial tests

Phase 1 trial testing D-Limonene Gelcaps in Xerostomia in 40 participants. Currently enrolling.

Timeline
15 February 2021
Primary endpoint
15 August 2027
15 May 2028

Quick facts

Lead sponsorStanford University
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposesupportive care
Enrollment40
Start date15 February 2021
Primary completion15 August 2027
Estimated completion15 May 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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:

Other trials of D-Limonene Gelcaps

Trials testing the same drug.

Other recruiting trials for Xerostomia

Currently open trials in the same condition.

Other Stanford University trials

Trials by the same sponsor.

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Data sources for this page

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