RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1 Study of d Limonene With Concurrent Radiation and Platinum Based Chemotherapy for Xerostomia Prevention in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Quick Facts

Study Start:2021-02-15

Study Completion:2027-02-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04392622

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: * 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	* History of allergic reactions attributed to citrus fruits * Pregnant or lactating

Inclusion Criteria

Exclusion 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:
* 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

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

Contacts and Locations

Study Contact

Camellia Djebroun

CONTACT

650-736-5564

cdjebrou@stanford.edu

Janelle Hua

CONTACT

650-725-2084

janhua@stanford.edu

Principal Investigator

Quynh-Thu Le

PRINCIPAL_INVESTIGATOR

Stanford Universiy

Study Locations (Sites)

Stanford University

Stanford, California, 94305

United States

Collaborators and Investigators

Sponsor: Stanford University

Quynh-Thu Le, PRINCIPAL_INVESTIGATOR, Stanford Universiy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-15

Study Completion Date2027-02-15

Study Record Updates

Study Start Date2021-02-15

Study Completion Date2027-02-15

Terms related to this study

Additional Relevant MeSH Terms

Xerostomia