Actively Recruiting
A Phase I Study of d-Limonene With Radiation and Platinum-Based Chemotherapy for Preventing Xerostomia in Locally Advanced Head and Neck Squamous Cell Carcinoma
Led by Stanford University · Updated on 2025-07-20
40
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of d-limonene, a dietary supplement, combined with radiation and platinum-based chemotherapy for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). The study aims to find the highest safe dose of d-limonene and to assess its potential to prevent severe dry mouth (xerostomia), a common side effect of cancer treatment. This phase 1 trial also examines patient compliance and the relationship between d-limonene levels in the blood, saliva flow, and dry mouth symptoms. Participants receive varying doses of d-limonene gelcaps orally, ranging from 2 to 8 grams daily, during chemoradiation treatment. Radiation therapy is delivered as intensity modulated radiotherapy (IMRT) at standard doses over 6.5 to 7 weeks, alongside cisplatin chemotherapy. The study includes a dose escalation and de-escalation design to determine the maximum tolerated dose of d-limonene. D-limonene administration continues daily for up to 4 months after chemoradiation. During the trial, participants are monitored for dose-limiting toxicities for 9 weeks and followed for xerostomia symptoms up to 12 months after treatment. Researchers assess saliva flow rates and use a xerostomia questionnaire to measure dry mouth severity. Blood tests measure d-limonene levels. Patient compliance with the supplement is tracked throughout the study. The total participation time includes treatment and extended follow-up to evaluate safety and symptom outcomes.
CONDITIONS
Brief Title
d-Limonene +Radiation +PlatinumBasedChemo for Xerostomia Prevention in LocallyAdvanced HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced loco regional squamous cell carcinoma of the nasopharynx, oropharynx, larynx, hypopharynx, or unknown primary with involved nodes
- Scheduled to receive definitive radiation therapy with concurrent platinum-based chemotherapy at Stanford
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Able to swallow d-limonene gelcaps at enrollment
- Adequate liver function within 2 weeks before registration (bilirubin ≤ 2 mg/dL; AST or ALT < 3 times upper limit of normal)
- Adequate blood counts within 2 weeks before registration (ANC ≥ 1,500/mm3; platelets ≥ 100,000/mm3; hemoglobin ≥ 8.0 g/dL)
- Adequate kidney function within 2 weeks before registration (serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min)
- Negative pregnancy test within 2 weeks before registration and agreement to use birth control during d-limonene treatment for women of childbearing potential
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- History of allergic reactions to citrus fruits
- Pregnant or lactating
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6.5 to 7 weeks
Participants receive d-limonene orally daily combined with radiation and platinum-based chemotherapy over approximately 6.5 to 7 weeks.
Daily dosing with radiation given in 33 to 35 fractions over the treatment period
Duration - Up to 4 months
Participants may continue daily d-limonene administration for up to 4 months after completion of chemoradiation to evaluate feasibility and compliance.
Regular visits during adjuvant period (visit schedule varies)
Duration - Up to 12 months post completion of chemoradiation
Participants are monitored for xerostomia symptoms and toxicity up to 12 months after completing chemoradiation.
Periodic follow-up visits for symptom assessment
Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
Research Team
C
Camellia Djebroun
K
Kelly Huang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
7
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