Using d-limonene to prevent dry mouth in head and neck cancer patients
A Phase I Study of d-Limonene With Concurrent Radiation and Platinum Based Chemotherapy for Xerostomia Prevention in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
This study is testing if taking d-limonene gelcaps can help prevent dry mouth in patients with advanced head and neck cancer who are undergoing radiation and chemotherapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT04392622 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced squamous cell carcinoma of the head and neck who are scheduled to receive chemoradiation.
Not a fit: Patients with early-stage head and neck cancer or those not undergoing chemoradiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of xerostomia in patients undergoing treatment for head and neck cancer.
How similar studies have performed: While the use of dietary supplements in cancer care is being explored, this specific combination of d-limonene with chemoradiation is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Stanford, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.