RecruitingPhase 1NCT04392622

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

A Phase I Study of d-Limonene With Concurrent Radiation and Platinum Based Chemotherapy for Xerostomia Prevention in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Sponsor

Stanford University

Enrollment

40 participants

Start Date

Feb 15, 2021

Study Type

INTERVENTIONAL

Conditions

Xerostomia

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding d-limonene (a compound found in citrus fruit peels) to the standard radiation and platinum-based chemotherapy regimen can reduce dry mouth (xerostomia), a debilitating side effect that many head and neck cancer patients experience after treatment. **You may be eligible if...** - You have confirmed squamous cell cancer of the head and neck (nasopharynx, oropharynx, larynx, or hypopharynx) at an advanced stage, scheduled for combined radiation and platinum chemotherapy at Stanford - Your overall health is good (ECOG 0-1) - You can swallow gel capsules - You have adequate liver, kidney, and blood function - If female and of childbearing potential, you agree to use birth control during treatment **You may NOT be eligible if...** - You have a known allergy to citrus fruits - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGD-Limonene Gelcaps

Administered orally at 2 to 8 grams daily

RADIATIONIntensity modulated radiotherapy (IMRT)

Standard of Care -All patients will receive standard radiation treatment of 66 to 70 Gy given in 33 to 35 fractions (2 to 2.12 Gy/fractions) over 6.5 to 7 weeks.

DRUGCisplatin

Standard of Care -Cisplatin as 100 mg/m2 IV

OTHERXerostomia questionnaire

Xerostomia questionnaire consists of 4 items on dryness while eating/speaking and 4 on dryness at rest. Patients rate each symptom on an 11 point ordinal Likert scale from 0 to 10, with higher scores indicating greater xerostomia