d-Limonene + Radiation + Chemo for Dry Mouth Prevention in Head and Neck Cancer
Trial Summary
What is the purpose of this trial?
This trial tests the safety of d-limonene, a citrus supplement, for head and neck cancer patients with severe dry mouth. It aims to find the safe dose and see if it can help increase saliva production to ease dry mouth symptoms.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment d-Limonene + Radiation + Chemo for preventing dry mouth in head and neck cancer?
Research shows that cisplatin-based chemotherapy combined with radiation therapy is effective in controlling tumors and improving survival in head and neck cancer. Additionally, intensity modulated radiotherapy (IMRT) helps reduce radiation doses to normal tissues, like salivary glands, which may help in preventing dry mouth.12345
Is the combination of d-Limonene, radiation, and chemotherapy safe for preventing dry mouth in head and neck cancer patients?
The combination of cisplatin (a chemotherapy drug) and radiation has been studied in head and neck cancer patients, showing some common side effects like nausea, vomiting, and kidney issues. However, it is generally considered effective and safe when used with caution. There is no specific safety data available for d-Limonene in this combination, but cisplatin and radiation have been used together safely in other studies.678910
How is the treatment with d-Limonene, radiation, and chemo different for preventing dry mouth in head and neck cancer?
This treatment is unique because it combines d-Limonene, a natural compound found in citrus oils, with radiation and chemotherapy to specifically target dry mouth prevention, which is a common side effect of head and neck cancer treatments. Traditional treatments focus on controlling the cancer itself, while this approach aims to improve quality of life by addressing a specific side effect.111121314
Research Team
Quynh-Thu Le
Principal Investigator
Stanford Universiy
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive d-limonene in combination with radiation and platinum-based chemotherapy
Adjuvant Treatment
Participants continue with adjuvant administration of d-limonene for compliance assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cisplatin
- D Limonene
- D-Limonene Gelcaps
- Intensity modulated radiotherapy (IMRT)
- Xerostomia questionnaire
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
National Institutes of Health (NIH)
Collaborator