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

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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