Trial Search Results

d-Limonene +Radiation +Platinum Based Chemo for Xerostomia Prevention in Locally Advanced Head and Neck Squamous Cell Carcinoma

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: D-Limonene Gelcaps
  • Radiation: Intensity modulated radiotherapy (IMRT)
  • Drug: Cisplatin
  • Other: Xerostomia questionnaire

Phase:

Phase 1

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mahjabin Noroozi
215-327-4649