This phase I trial studies the best dose, possible benefits and/or side effects of d-limonene given together with radiation therapy and cisplatin in treating patients with head and neck squamous cell cancer that has spread to nearby tissue or lymph nodes (locally advanced). Xerostomia (dry mouth) is the most common late side effect from radiation therapy. D-limonene is a dietary supplement that activates an enzyme which may stimulate salivary cells. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving d-limonene together with radiation therapy and cisplatin may prevent or improve radiation-induced xerostomia in patients with head and neck squamous cell cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT04392622.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo AltoStatus: Active
Contact: Quynh-Thu Xuan Le
Phone: 650-498-5032
PRIMARY OBJECTIVE:
I. To determine the maximum tolerated dose of limonene, (+)- (d limonene) when combined with radiation and platinum based chemotherapy in subjects with loco-regionally advanced head and neck squamous cell carcinoma (HNSCC) based upon dose limiting toxicity (DLT).
SECONDARY OBJECTIVES:
I. To evaluate the feasibility and subject compliance with adjuvant administration of d limonene until a maximum of 4 months after completion of chemoradiation.
II. To correlate the level of d-limonene measured in plasma to the dose level(s) administered.
III. To correlate the level of d-limonene measured in the plasma to saliva flow rate.
IV. To evaluate for improvement in quality of life (QoL) as assessed by scores for the xerostomia questionnaire and the European Organization for Research and Treatment of Cancer (EORTC) questionnaire.
OUTLINE: This is a dose-escalation study of limonene, (+)-.
Patients receive limonene, (+)- orally (PO) once daily (QD) or twice daily (BID) for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo standard of care radiation therapy daily for a total of 33 to 35 fractions over 6.5-7 weeks and receive cisplatin intravenously (IV) every 21 days for up to 3 cycles or weekly for 7 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up at 1, 2, 3, 4, 6, 9, and 12 months after chemoradiation therapy.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorQuynh-Thu Xuan Le
