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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT04392622
Phase
PHASE1
Status
Recruiting
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Conditions

  • Xerostomia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • D-Limonene Gelcaps — DRUG
    Administered orally at 2 to 8 grams daily
  • Intensity modulated radiotherapy (IMRT) — RADIATION
    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 — DRUG
    Standard of Care -Cisplatin as 100 mg/m2 IV
  • Xerostomia questionnaire — OTHER
    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

Study Details

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.

Key Dates

First listed
May 19, 2020
Start date
Feb 15, 2021
Status verified
Jul 2025
Primary completion
Aug 15, 2027
Completion
May 15, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: d-limonene -2gram
    2 gram d-limonene orally, once daily delivered during chemoradiation
  • Experimental: d-limonene -4gram
    4 gram d-limonene orally, as 2 grams 2 times daily delivered during chemoradiation
  • Experimental: d-limonene -6gram
    6 gram d-limonene orally, as 3 grams 2 times daily delivered during chemoradiation
  • Experimental: d-limonene -8gram
    8 gram d-limonene orally, as 4 grams 2 times daily delivered during chemoradiation
  • Experimental: de-escalation dose d-limonene -6gram
    6 gram d-limonene orally, as 3 grams 2 times daily delivered during chemoradiation
  • Experimental: de-escalation dose d-limonene -4gram
    4 gram d-limonene orally, as 2 grams 2 times daily delivered during chemoradiation
  • Experimental: de-escalation dose d-limonene -2gram
    2 gram d-limonene orally, once daily delivered during chemoradiation

Primary Outcome Measure

Dose limiting Toxicity [ Time Frame: 9 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Camellia Djebroun
[email protected]
650-736-5564
Kelly Huang
[email protected]
650-724-4606
Quynh-Thu Le, M.D. (PRINCIPAL_INVESTIGATOR)

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