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

Launched by STANFORD UNIVERSITY · May 13, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the use of a dietary supplement called d-limonene to help prevent severe dry mouth, known as xerostomia, in patients with advanced head and neck cancer. Many patients experience this dry mouth as a side effect of their cancer treatments, like chemotherapy and radiation. The trial is in the early testing phase and is looking for participants who are scheduled to receive radiation and chemotherapy at Stanford. Eligible participants are typically adults between the ages of 65 and 74 who have a confirmed diagnosis of certain types of head and neck cancer.

If you qualify to take part in this trial, you'll be given d-limonene in gel capsule form while you undergo your cancer treatment. You'll need to be able to swallow these capsules and meet some health criteria, such as having a certain level of liver and kidney function. The study aims to determine if d-limonene is safe and helps improve dry mouth symptoms during treatment. It's important to know that if you have a history of allergies to citrus fruits, are pregnant, or breastfeeding, you won't be able to participate.

Gender

ALL

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