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d-Limonene for Dry Mouth Prevention in Head and Neck Cancer

This study is looking at whether d-Limonene gelcaps, a dietary supplement, can help prevent severe dry mouth (xerostomia) in people with advanced head and neck cancer. Dry mouth is a common side effect of standard treatments like Intensity Modulated Radiotherapy (IMRT) and Cisplatin chemotherapy. Researchers want to find the safest and most effective dose of d-Limonene when given along with these standard cancer treatments. You might be able to join if you are an adult with a specific type of advanced head and neck squamous cell carcinoma. Success for this study means finding a safe dose of d-Limonene and seeing if it helps with dry mouth. The current recruitment status is unclear, and the study plans to enroll 40 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 40 participants, but the phase of the study is not specified.
What's involved
Participants will receive standard radiation and chemotherapy, along with d-Limonene gelcaps daily for up to 4 months after treatment. You will also complete a xerostomia questionnaire to rate your dry mouth symptoms.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Dose Limiting Toxicity, is measured at 9 weeks. There is also a secondary objective to evaluate d-limonene administration for up to 4 months after chemoradiation.

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NCT04392622

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

Recruiting
PHASE1Ages 18+InterventionalSupportive care
Stanford University
~40 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:D-Limonene GelcapsIntensity modulated radiotherapy (IMRT)CisplatinXerostomia questionnaire

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting Toxicity
Measured over 9 weeks

Conditions

Xerostomia

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Quynh-Thu Le · PRINCIPAL_INVESTIGATOR · Stanford Universiy

Who to contact

Camellia Djebroun
[email protected]
650-736-5564
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

History of allergic reactions attributed to citrus fruits
Pregnant or lactating

What this trial measures

  • Dose limiting Toxicity9 weeks

    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 study drug. The outcome will be reported as the number of participants per dose level who experience any DLT (a number without dispersion / variance).