Using d-limonene to prevent dry mouth in head and neck cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and maximum tolerated dose of d-limonene, a dietary supplement, when combined with radiation and platinum-based chemotherapy for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). The primary objective is to assess dose-limiting toxicity, while secondary objectives include evaluating patient compliance with d-limonene administration and correlating plasma levels of the supplement with saliva flow rates and xerostomia symptoms. Participants will receive d-limonene gelcaps alongside their cancer treatment to potentially alleviate severe dry mouth caused by therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• Stanford University
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Quynh-Thu Le — Stanford Universiy
• Study coordinator: Camellia Djebroun
• Email: cdjebrou@stanford.edu
• Phone: 650-736-5564

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.