NCT04392622 d-Limonene +Radiation +PlatinumBasedChemo for Xerostomia Prevention in LocallyAdvanced HNSCC
| NCT ID | NCT04392622 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Stanford University |
| Condition | Xerostomia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-02-15 |
| Primary Completion | 2027-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2021-02-15 with a primary completion date of 2027-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Quynh-Thu Le
PRINCIPAL INVESTIGATOR
Stanford Universiy
Frequently Asked Questions
Who can join the NCT04392622 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Xerostomia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04392622 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04392622 currently recruiting?
Yes, NCT04392622 is actively recruiting participants. Contact the research team at cdjebrou@stanford.edu for enrollment information.
Where is the NCT04392622 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT04392622 clinical trial?
NCT04392622 is sponsored by Stanford University. The principal investigator is Quynh-Thu Le at Stanford Universiy. The trial plans to enroll 40 participants.