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d-Limonene +Radiation +PlatinumBasedChemo for Xerostomia Prevention in LocallyAdvanced HNSCC | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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)

NCT04392622•Stanford University

View on ClinicalTrials.gov

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.

Detailed Description

Primary Objective:To determine the maximum tolerated dose (MTD) of d limonene when combined with radiation and platinum based chemotherapy in subjects with loco regionally advanced head and neck squamous cell carcinoma (HNSCC) based upon dose limiting toxicity (DLT) Secondary Objective: * To evaluate the feasibility and subject compliance with adjuvant administration of d limonene daily up to a maximum of 4 months after completion of chemoradiation * To correlate the level of d-limonene measured in the plasma to the dose levels(s) administered to the subject * To correlate the level of d limonene measured in the plasma to saliva flow rate and xerostomia questionnaire scores in subjects enrolled in this trial

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
+4 more criteria

Exclusion Criteria

•History of allergic reactions attributed to citrus fruits
•Pregnant or lactating

Locations (1)

Stanford University

Stanford, California, United States

Key Dates

Start Date

February 15, 2021

Primary Completion Date

August 15, 2027

Completion Date

May 15, 2028

Last Updated

July 20, 2025

Enrollment

ESTIMATED participants

Conditions

Xerostomia

Interventions

D-Limonene Gelcaps

DRUG

Intensity modulated radiotherapy (IMRT)

RADIATION

Cisplatin

DRUG

Xerostomia questionnaire

OTHER

Contacts

Camellia Djebroun

CONTACT

650-736-5564 cdjebrou@stanford.edu

Kelly Huang

CONTACT

650-724-4606 kelhuang@stanford.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia

Management of Radiotherapy-related Xerostomia With Green Tea and Peppermint

The Efficacy of Hibiscus Sabdariffa in Xerostomia

Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy

The Impact of Oral Health in HIV Patients on Antiretroviral Therapy

Prevalence of Late Xerostomia and Hyposalivation with Associated Risk Factors in Survivors of Head and Neck Cancer After Radiotherapy: a Multi-centric Cross-sectional Study