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Spots Global Cancer Trial Database for Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers

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Trial Identification

Brief Title: Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers

Official Title: A Phase 2a Randomized, Parallel Group, Open Label, Multicenter Study to Assess the Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Study ID: NCT03515538

Conditions

Oral Mucositis

Study Description

Brief Summary: The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the duration or length of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients in arms 1, 2 and 3 will also receive RRx-001 on different schedules.

Detailed Description: The standard treatment for head and neck cancer currently includes a chemotherapy drug called cisplatin that is given by intravenous (IV) infusion and radiation, which is delivered from a machine that precisely targets the tumor. One common and unfortunate side effect of treatment with cisplatin and radiation is oral mucositis, which refers to irritation of the lining of the mouth. Oral mucositis is a serious problem 1) because the open mouth sores from oral mucositis may lead to severe pain, nutritional problems and dehydration from an inability to eat and drink, an increased risk of infection from bacteria and fungus and delay or discontinuation of treatment and 2) because there is only one approved therapy to treat or prevent it.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

John Wayne Cancer Institute @ Providence St. John's Health Center, Santa Monica, California, United States

Centura Health Research Center, Denver, Colorado, United States

George Washington University, Washington, District of Columbia, United States

Florida Hospital, Orlando, Florida, United States

Montefiore Medical Center, Bronx, New York, United States

East Carolina University, Greenville, North Carolina, United States

University of Cincinnati Medical Center, Cincinnati, Ohio, United States

Ohio State University, Columbus, Ohio, United States

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Ballad Health, Johnson City, Tennessee, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

UT Southwestern, Dallas, Texas, United States

Contact Details

Name: Bryan Oronsky, MD, PhD

Affiliation: EpicentRx, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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