NCT04392622View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 15, 2021

Primary Completion Date

August 15, 2027

Study Completion Date

May 15, 2028

Conditions
Xerostomia
Interventions
DRUG

D-Limonene Gelcaps

Administered orally at 2 to 8 grams daily

RADIATION

Intensity 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.

DRUG

Cisplatin

Standard of Care -Cisplatin as 100 mg/m2 IV

OTHER

Xerostomia 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

Trial Locations (1)

94305

RECRUITING

Stanford University, Stanford

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Cancer Institute (NCI)

NIH

lead

Stanford University

OTHER