Citrus compound d-limonene put to the test against radiation-induced dry mouth
NCT ID NCT04392622
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This phase 1 trial tests whether d-limonene, a compound found in citrus peel, can safely prevent severe dry mouth (xerostomia) in people with head and neck cancer undergoing radiation and chemotherapy. Participants take d-limonene capsules daily during their standard cancer treatment. The study primarily looks at safety and tolerability, checking for side effects that could delay radiation or require dose reductions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a dietary supplement called d-limonene, a compound found in citrus peel
- What this could lead to
- If safe and effective, d-limonene could offer a simple, low-cost way to prevent severe dry mouth in people undergoing radiation for head and neck cancer.
- What could go wrong
- This is an early phase 1 trial with only 40 participants, focused on safety. It is too small to prove whether d-limonene actually prevents dry mouth, and side effects like diarrhea or abdominal pain are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of advanced loco regional squamous cell carcinoma of the nasopharynx (AJCC v8 Stage II IV); oropharynx (AJCC v8 Stage I III for HPV+ cancer, excluding T1 2N0; AJCC v8 Stage III IV for Human papillomavirus (HPV) negative cancer); larynx (AJCC v8 Stage III to IV); or hypopharynx (AJCC v8 Stage III to IV), scheduled to undergo chemoradiation. Patients with squamous cell carcinoma of the head and neck from an unknown primary site with involved nodes (N1 to 3) also qualify. * Scheduled to received definitive RT with concurrent platinum based chemotherapy at Stanford * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1 * Must be able to swallow d limonene gelcaps at the time of enrollment. * Adequate hepatic function within 2 weeks prior to registration defined as follows: Bilirubin ≤ 2 mg/dL; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 times the upper limit of normal * Adequate hematologic function within 2 weeks prior to registration defined as follows: * Absolute neutrophil count (ANC): ≥ 1,500/mm3 * Platelets: ≥ 100,000/mm3 * Hemoglobin: ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable). * Adequate renal function defined as follows: Serum creatinine ≤ 1.5 mg/dL within 2 weeks prior to registration or creatinine clearance (CC) ≥ 50 mL/min within 2 weeks prior to registration determined by 24 hour collection or estimated by Cockcroft Gault formula: CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dL) x (72)\] CCr female = 0.85 x (CrCl male) * Negative serum pregnancy test within 2 weeks prior to registration and agreement to use a birth control method during the entire duration of d limonene treatment for women of childbearing potential * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * History of allergic reactions attributed to citrus fruits * Pregnant or lactating
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford University
RECRUITINGStanford, California, 94305, United States
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