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Alkylating agents

d-Limonene + Radiation + Chemo for Dry Mouth Prevention in Head and Neck Cancer

Phase 1
Recruiting
Led By Quynh-Thu Le
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed diagnosis of advanced loco regional squamous cell carcinoma of the nasopharynx, oropharynx, larynx, or hypopharynx scheduled to undergo chemoradiation
Scheduled to receive definitive RT with concurrent platinum-based chemotherapy at Stanford
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post completion of chemoradiation
Awards & highlights

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.

Who is the study for?
This trial is for adults with advanced head and neck squamous cell carcinoma, who are about to receive chemoradiation. They must be able to swallow pills, not have citrus allergies, and women must not be pregnant or breastfeeding. Participants need good liver, kidney, and blood function and a performance status indicating they can care for themselves.Check my eligibility
What is being tested?
The study tests if d-Limonene gelcaps can prevent dry mouth in cancer patients undergoing radiation and platinum-based chemotherapy. It also involves completing questionnaires about xerostomia symptoms to assess the effectiveness of the treatment.See study design
What are the potential side effects?
Potential side effects may include typical reactions from chemotherapy like nausea, fatigue, hair loss; radiation-related skin changes; plus any unknown risks associated with d-Limonene since it's being studied as a new use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a confirmed diagnosis of advanced throat cancer and am scheduled for chemoradiation.
Select...
I am scheduled for radiation and platinum-based chemotherapy at Stanford.
Select...
I can swallow gel capsules.
Select...
I am fully active or can carry out light work.
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My kidney function is good, with creatinine levels low or clearance high.
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My liver is functioning well, with normal bilirubin and enzyme levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post completion of chemoradiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post completion of chemoradiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting Toxicity
Secondary outcome measures
Feasibility of adjuvant d-limonene administration
Xerostomia toxicity

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
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%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Trial Design

7Treatment groups
Experimental Treatment
Group I: de-escalation dose d-limonene -6gramExperimental Treatment4 Interventions
6 gram d-limonene orally, as 3 grams 2 times daily delivered during chemoradiation
Group II: de-escalation dose d-limonene -4gramExperimental Treatment4 Interventions
4 gram d-limonene orally, as 2 grams 2 times daily delivered during chemoradiation
Group III: de-escalation dose d-limonene -2gramExperimental Treatment4 Interventions
2 gram d-limonene orally, once daily delivered during chemoradiation
Group IV: d-limonene -8gramExperimental Treatment4 Interventions
8 gram d-limonene orally, as 4 grams 2 times daily delivered during chemoradiation
Group V: d-limonene -6gramExperimental Treatment4 Interventions
6 gram d-limonene orally, as 3 grams 2 times daily delivered during chemoradiation
Group VI: d-limonene -4gramExperimental Treatment4 Interventions
4 gram d-limonene orally, as 2 grams 2 times daily delivered during chemoradiation
Group VII: d-limonene -2gramExperimental Treatment4 Interventions
2 gram d-limonene orally, once daily delivered during chemoradiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Intensity modulated radiotherapy (IMRT)
2018
N/A
~220

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,705 Previous Clinical Trials
7,507,348 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,425 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,680 Previous Clinical Trials
40,928,566 Total Patients Enrolled
1 Trials studying Dry Mouth
100 Patients Enrolled for Dry Mouth

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04392622 — Phase 1
Dry Mouth Research Study Groups: de-escalation dose d-limonene -6gram, d-limonene -6gram, d-limonene -2gram, d-limonene -4gram, de-escalation dose d-limonene -4gram, de-escalation dose d-limonene -2gram, d-limonene -8gram
Dry Mouth Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04392622 — Phase 1
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04392622 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other examples of Cisplatin being tested in a clinical setting?

"Cisplatin is being trialled in 713 active clinical trials, with 284 of those trials in Phase 3. There is significant global interest in Cisplatin, with trials taking place in 43092 locations. Shanghai is a major hub for Cisplatin clinical trials, with several ongoing trials taking place in the city."

Answered by AI

How is Cisplatin most often employed?

"Cisplatin can be used to treat certain types of cancer that have progressed, such as advanced ovarian or testicular cancer, or that have not responded to other forms of treatment."

Answered by AI

What is the FDA's official opinion on Cisplatin?

"Cisplatin received a score of 1 because, as a Phase 1 trial medication, there is limited data supporting both its safety and efficacy."

Answered by AI

Can people with the relevant medical condition participate in this trial?

"Yes, this is an ongoing recruitment campaign as stated on clinicaltrials.gov. The trial was announced on February 15th, 2021 and was edited on March 11th, 2022. They are looking for 24 individuals at a single location."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
d-Limonene +Radiation +Platinum Based Chemo for Xerostomia Prevention in Locally Advanced Head and Neck Squamous Cell Carcinoma
2021. "d-Limonene +Radiation +Platinum Based Chemo for Xerostomia Prevention in Locally Advanced Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04392622.
All > Squamous Cell Carcinoma
~10 spots leftby Feb 2026
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