Phase 1 Study of d-Limonene with Radiation and Platinum Chemotherapy to Prevent Dry Mouth in Advanced Head and Neck Cancer

What this Trial Is About

Researchers are evaluating the safety of d-limonene, a dietary supplement, as a possible treatment to prevent severe dry mouth xerostomia in patients with locally advanced head and neck squamous cell carcinoma HNSCC. This phase 1 study focuses on determining the maximum tolerated dose of d-limonene when given alongside radiation and platinum-based chemotherapy. The study also aims to assess how well patients can follow the treatment and to explore how d-limonene levels in plasma relate to saliva flow and dry mouth symptoms. Participants receive different oral doses of d-limonene ranging from 2 to 8 grams daily during their chemoradiation treatment. Radiation is delivered as intensity modulated radiotherapy IMRT over 6.5 to 7 weeks, while chemotherapy involves cisplatin given intravenously. The d-limonene dosing schedules vary from once daily to twice daily during this concurrent treatment period. Throughout the study, participants will be monitored for dose-limiting toxicities over 9 weeks. Researchers will track compliance with d-limonene administration for up to 4 months after chemoradiation ends. Dry mouth symptoms will be measured using a questionnaire at 12 months post-treatment. Blood tests will be done to measure d-limonene levels and assess liver, kidney, and blood function. The total study duration extends up to the primary completion date, with ongoing safety and symptom evaluations.

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