d-Limonene +Radiation +PlatinumBasedChemo for Xerostomia Prevention in LocallyAdvanced HNSCC
NCT ID: NCT04392622
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2021-02-15
2028-05-15
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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d-limonene -2gram
2 gram d-limonene orally, once daily delivered during chemoradiation
D-Limonene Gelcaps
Administered orally at 2 to 8 grams daily
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.
Cisplatin
Standard of Care -Cisplatin as 100 mg/m2 IV
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
d-limonene -4gram
4 gram d-limonene orally, as 2 grams 2 times daily delivered during chemoradiation
D-Limonene Gelcaps
Administered orally at 2 to 8 grams daily
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.
Cisplatin
Standard of Care -Cisplatin as 100 mg/m2 IV
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
d-limonene -6gram
6 gram d-limonene orally, as 3 grams 2 times daily delivered during chemoradiation
D-Limonene Gelcaps
Administered orally at 2 to 8 grams daily
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.
Cisplatin
Standard of Care -Cisplatin as 100 mg/m2 IV
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
d-limonene -8gram
8 gram d-limonene orally, as 4 grams 2 times daily delivered during chemoradiation
D-Limonene Gelcaps
Administered orally at 2 to 8 grams daily
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.
Cisplatin
Standard of Care -Cisplatin as 100 mg/m2 IV
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
de-escalation dose d-limonene -6gram
6 gram d-limonene orally, as 3 grams 2 times daily delivered during chemoradiation
D-Limonene Gelcaps
Administered orally at 2 to 8 grams daily
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.
Cisplatin
Standard of Care -Cisplatin as 100 mg/m2 IV
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
de-escalation dose d-limonene -4gram
4 gram d-limonene orally, as 2 grams 2 times daily delivered during chemoradiation
D-Limonene Gelcaps
Administered orally at 2 to 8 grams daily
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.
Cisplatin
Standard of Care -Cisplatin as 100 mg/m2 IV
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
de-escalation dose d-limonene -2gram
2 gram d-limonene orally, once daily delivered during chemoradiation
D-Limonene Gelcaps
Administered orally at 2 to 8 grams daily
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.
Cisplatin
Standard of Care -Cisplatin as 100 mg/m2 IV
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
Interventions
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D-Limonene Gelcaps
Administered orally at 2 to 8 grams daily
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.
Cisplatin
Standard of Care -Cisplatin as 100 mg/m2 IV
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
Eligibility Criteria
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Inclusion Criteria
* 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:
Serum creatinine ≤ 1.5 mg/dL within 2 weeks prior to registration or creatinine clearance (CC) ≥ 50 mL/min within 2 weeks prior to registration determined by 24 hour collection or estimated by Cockcroft Gault formula:
CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dL) x (72)\] CCr female = 0.85 x (CrCl male)
* 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
Exclusion Criteria
* Pregnant or lactating
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Stanford University
OTHER
Responsible Party
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Principal Investigators
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Quynh-Thu Le
Role: PRINCIPAL_INVESTIGATOR
Stanford Universiy
Locations
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Stanford University
Stanford, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2021-03256
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB-51656
Identifier Type: -
Identifier Source: org_study_id
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