Parotid Duct Sparing Radiation for Head and Neck Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method of delivering radiation therapy to individuals with oropharyngeal cancer, aiming to reduce dry mouth, a common and bothersome side effect. It compares Parotid Sparing Radiation Therapy Planning, which protects the parotid ducts (part of the saliva-producing glands), to the standard method that protects the entire gland. The goal is to determine if this new method reduces dry mouth after treatment. Candidates may qualify if they have oropharyngeal cancer and plan to receive radiation therapy, but do not have conditions like Sjogren's disease or existing dry mouth issues. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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 team or your doctor.
What prior data suggests that this radiation therapy planning is safe for head and neck cancer patients?
Research has shown that protecting the parotid glands (salivary glands near the jaw) during radiation treatment can reduce dry mouth symptoms and improve quality of life. One study found that protected glands received much less radiation than unprotected ones, resulting in less dry mouth. This indicates that focusing on protecting these glands during treatment could be safer for patients.
Another study discovered that lowering the radiation dose to the salivary glands can enhance saliva production and reduce dry mouth issues. However, this approach carries a risk of not effectively targeting the cancer, requiring careful planning and monitoring.
Overall, evidence suggests that protecting the parotid glands is a promising way to reduce radiation side effects in head and neck cancer treatments. However, like any treatment, it must be executed carefully to ensure safety and effectiveness.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it explores a new approach to radiation therapy for head and neck cancers that specifically targets the parotid ducts. Unlike standard treatment, which focuses on the entire parotid gland, this method aims to spare the delicate parotid ducts from high radiation doses. This could potentially reduce side effects like dry mouth, improving quality of life for patients undergoing treatment. By minimizing the radiation exposure to these ducts, the trial hopes to maintain more of the salivary gland function, which is a significant advancement over current practices.
What evidence suggests that this trial's treatments could be effective for reducing radiation-induced dry mouth in head and neck cancer patients?
Research has shown that protecting the parotid ducts during radiation therapy can reduce dry mouth symptoms in patients with head and neck cancer. In this trial, participants in the Experimental Arm will have their treatment planned to minimize the dose to the expanded parotid ducts. One study found that patients who had their parotid ducts protected reported fewer moderate-to-severe dry mouth symptoms compared to those who received the usual treatment. Another study found that protecting the parotid glands improves quality of life by reducing these symptoms. Participants in the Standard Arm will undergo treatment planning using the overall parotid gland volume as the organ-at-risk, following standard clinical practice. While protecting the entire parotid gland is known to help, focusing on the ducts might offer even better results. These findings suggest that parotid duct-sparing techniques could be a promising way to lessen the side effects of radiation therapy.26789
Who Is on the Research Team?
David Fried, PhD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for individuals with oropharyngeal cancer who are about to receive definitive radiotherapy. It's designed to see if sparing the parotid ducts during treatment can reduce dry mouth symptoms after therapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MRI-guided parotid ductal sparing or standard parotid gland sparing radiotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on xerostomia outcomes
What Are the Treatments Tested in This Trial?
Interventions
- MRI sialography
- Parotid Duct Sparing Radiation Therapy Planning
- Parotid Sparing Radiation Therapy Planning
Trial Overview
The study compares two radiation planning techniques: MRI-guided parotid ductal sparing versus standard mean parotid gland sparing. The goal is to determine which method better prevents dry mouth in patients post-treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to this arm will have their organs-at-risk include the expanded parotid ducts. Treatment planning will aim to explicitly minimize the dose to these structures. If achieving this dose is not possible, it will be documented as a study deviation, but treatment will proceed.
Participants in this arm will undergo treatment planning using the overall parotid gland volume as the organ-at-risk, following the standard clinical practice. Entire parotid gland will be considered, not the parotid ducts.
Find a Clinic Near You
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator
Citations
Sparing Parotid Ducts Via MRI Sialography for Reduced ...
Patients who received this type of duct-sparing RT had fewer moderate-to-severe dry mouth symptoms compared to patients treated with standard ...
Parotid gland sparing IMRT for head and neck cancer ...
Conclusion. Parotid gland sparing IMRT for head and neck cancer patients improves xerostomia related quality of life compared to conventional radiation both in ...
Parotid sparing adaptive radiotherapy in head and neck ...
Anatomical changes during the course of parotid sparing IMRT for head and neck cancer can lead to an increase in the actual dose absorbed by the parotid glands.
Parotid Gland Stem Cell Sparing Radiation Therapy for ...
The primary endpoint was >75% reduction in parotid gland saliva production compared with pretreatment production (FLOW12M).
Influence of parotid-sparing radiotherapy on xerostomia in ...
Discussion. These results demonstrate that parotid-sparing radiotherapy protocols for head and neck cancer patients are effective in diminishing radiation ...
A prospective study of salivary function sparing in patients with ...
Sparing of the parotid glands translates into objective and subjective improvement of both xerostomia and QOL scores in patients with head-and-neck cancers ...
Hazards of sparing the ipsilateral parotid gland in the node ...
A spatial evaluation revealed a significantly higher incidence of marginal failures and true misses in the cohort of patients who underwent IMRT with the ...
Sparing all salivary glands with IMRT for head and neck ...
Patients treated to the bilateral neck with all-gland-sparing IMRT answered xerostomia (XQ) and head-and-neck quality of life (HNQOL) questionnaires.
Parotid Sparing Study in Head and Neck Cancer Patients ...
Treated parotid glands received an average dose of 5745 cGy, while spared glands received only 1986 cGy (p < 0.0001).
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