Cisplatin for Dry Mouth

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dry MouthCisplatin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at the safety of d-limonene, a food supplement, as a possible treatment for severe dry mouth caused by cancer treatments.

Eligible Conditions
  • Dry Mouth

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 12 months post completion of chemoradiation

Month 12
Xerostomia toxicity
4 months
Feasibility of adjuvant d-limonene administration
9 weeks
Dose limiting Toxicity

Trial Safety

Side Effects for

Gemcitabine Plus Cisplatin (GC)
51%Neutropenia
47%Leukopenia
46%Nausea
43%Vomiting
35%Anaemia
31%Decreased appetite
26%Haemoglobin decreased
26%Fatigue
25%Constipation
25%White blood cell count decreased
24%Neutrophil count decreased
19%Alanine aminotransferase increased
13%Platelet count decreased
12%Rash
10%Thrombocytopenia
10%Aspartate aminotransferase increased
9%Blood sodium decreased
8%Hypokalaemia
7%Pyrexia
7%Insomnia
6%Cough
6%Hyponatraemia
6%Lymphopenia
6%Blood creatinine increased
6%Diarrhoea
6%Dyspepsia
6%Red blood cell count decreased
4%Dizziness
2%Bone marrow failure
1%Dyspnoea
1%Pulmonary embolism
1%Superior vena cava syndrome
1%Cerebral infarction
1%Embolism venous
1%Ischaemic stroke
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01005680) in the Gemcitabine Plus Cisplatin (GC) ARM group. Side effects include: Neutropenia with 51%, Leukopenia with 47%, Nausea with 46%, Vomiting with 43%, Anaemia with 35%.

Trial Design

7 Treatment Groups

de-escalation dose d-limonene -6gram
1 of 7
d-limonene -6gram
1 of 7
d-limonene -2gram
1 of 7
de-escalation dose d-limonene -4gram
1 of 7
d-limonene -4gram
1 of 7
de-escalation dose d-limonene -2gram
1 of 7
d-limonene -8gram
1 of 7

Experimental Treatment

24 Total Participants · 7 Treatment Groups

Primary Treatment: Cisplatin · No Placebo Group · Phase 1

de-escalation dose d-limonene -6gramExperimental Group · 4 Interventions: Xerostomia questionnaire, D-Limonene Gelcaps, Cisplatin, Intensity modulated radiotherapy (IMRT) · Intervention Types: Other, Drug, Drug, Radiation
d-limonene -6gramExperimental Group · 4 Interventions: Xerostomia questionnaire, D-Limonene Gelcaps, Cisplatin, Intensity modulated radiotherapy (IMRT) · Intervention Types: Other, Drug, Drug, Radiation
d-limonene -2gramExperimental Group · 4 Interventions: Xerostomia questionnaire, D-Limonene Gelcaps, Cisplatin, Intensity modulated radiotherapy (IMRT) · Intervention Types: Other, Drug, Drug, Radiation
de-escalation dose d-limonene -4gramExperimental Group · 4 Interventions: Xerostomia questionnaire, D-Limonene Gelcaps, Cisplatin, Intensity modulated radiotherapy (IMRT) · Intervention Types: Other, Drug, Drug, Radiation
d-limonene -4gramExperimental Group · 4 Interventions: Xerostomia questionnaire, D-Limonene Gelcaps, Cisplatin, Intensity modulated radiotherapy (IMRT) · Intervention Types: Other, Drug, Drug, Radiation
de-escalation dose d-limonene -2gramExperimental Group · 4 Interventions: Xerostomia questionnaire, D-Limonene Gelcaps, Cisplatin, Intensity modulated radiotherapy (IMRT) · Intervention Types: Other, Drug, Drug, Radiation
d-limonene -8gramExperimental Group · 4 Interventions: Xerostomia questionnaire, D-Limonene Gelcaps, Cisplatin, Intensity modulated radiotherapy (IMRT) · Intervention Types: Other, Drug, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Intensity modulated radiotherapy (IMRT)
2018
N/A
~220

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months post completion of chemoradiation

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,161 Previous Clinical Trials
35,687,018 Total Patients Enrolled
Quynh-Thu LePrincipal InvestigatorStanford Universiy
10 Previous Clinical Trials
895 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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