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 |
Trial Parameters
Eligibility Fast-Check
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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 *