Health Trials

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

ConditionXerostomia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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

Qualifiers

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.

Disqualifiers

History of allergic reactions attributed to citrus fruits

Pregnant or lactating

Trial design

Treatments tested in this trial

  • D-Limonene Gelcaps
  • Intensity modulated radiotherapy (IMRT)
  • Cisplatin
  • Xerostomia questionnaire

Treatment groups

40 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators

Stanford University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov