RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer (KEVLARx)

UVA Tracking #
HSR230421
Principal Investigator
Varinder Kaur
Contact
Varinder Kaur
Contact Phone
434.924.5226
Official Trial Title
A Randomized Placebo-Controlled Trial of Two Schedules
of RRx-001 for the Attenuation of Severe Oral Mucositis in Patients Receiving Concomitant Chemoradiation for the
Treatment of Locally Advanced Squamous Cell Carcinoma
of the Oral Cavity or Orophary
Study Description

IRB-HSR#: HSR230421
PI Name: Varinder Kaur, MD
Contact Information For PI: Phone: 434-924-9333; Email: VK4Q@uvahealth.org

Study Description:

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with head and neck cancer experiencing severe oral mucositis with no prior radiotherapy to the head and neck region, and no prior or current use of an approved or investigational anticancer drug. The purpose of the study is to test if RRx-001, an investigational medicine, can reduce the rate of oral mucositis in head and neck cancer patients receiving treatment with cisplatin and radiation. This study is called KEVLARx because Kevlar is a bulletproof material and the hope is that the experimental anticancer agent, RRx-001, added to the chemotherapy drug, cisplatin, and radiation treatment, ideally protects the normal tissues and reduces the duration or length of severe mucositis.

Participation is completely voluntary. The study involves you being given RRx-001 or Placebo by intravenous infusion (delivered through your vein) twice a week for two weeks. You can remain on study about 9 weeks, provided your tumor does not get worse and you do not experience side effects that prevent you from continuing the treatment. After you are finished taking the treatments, you will be contacted by the study site every 3 months for the first year and every 6 months for the second year for a total of 24 months.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. These include:
- Medical & Oncological History
- Dental Assesment
- Questionnaires
- Oral Mucositis/WHO Assessment
- Physical Exam
- Oral Mucositis Assesment
- Adverse Events
- Concomitant medications & procedures
- ECG
- Pregnancy Test

Additional information found here: https://www.clinicaltrials.gov/study/NCT05966194?titles=KEVLARx&rank=1

Compensation

$65.00 per visit