Study on Adding BMX-001 or a Placebo to Usual Chemoradiation Therapy for Head and Neck Cancer
Sponsor: NRG Oncology
ClinicalTrials ID:NCT06532279
This clinical trial is testing whether adding BMX-001, a drug that protects against radiation damage, can help reduce mouth sores in patients receiving chemoradiation for head and neck cancer. The study compares BMX-001 with a placebo to see which is more effective in managing these side effects.
Patient Parameters
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Program Overview
This study aims to find out if adding BMX-001, a drug that protects normal tissues from radiation damage, to the usual treatment can better reduce mouth sores in patients undergoing chemoradiation for head and neck cancer. Mouth sores are a common and painful side effect of this treatment, making it hard to eat and swallow. The usual care involves using mouth rinses and pain medications. By adding BMX-001, researchers hope to improve the management of these side effects.
Description
The main goal of this study is to compare how well BMX-001 works against a placebo in reducing severe mouth sores in patients receiving radiation and chemotherapy for head and neck cancer. The study will also look at how long these sores last and assess other side effects like dry mouth and skin reactions from radiation.
Participants will be randomly assigned to one of two groups. One group will receive the usual treatment with a placebo, while the other group will receive BMX-001 along with the usual treatment. Both groups will undergo regular imaging tests and may have blood samples taken for further research.
After completing the treatment, participants will have follow-up visits at 1, 2, 3, 6, 12, and 24 months to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be scheduled to receive radiation and cisplatin chemotherapy as the main treatment for head and neck cancer.
- At least two areas in the mouth must receive a specific amount of radiation.
- Must have a confirmed diagnosis of certain types of head and neck cancer.
- Must be able to receive a specific type of radiation therapy.
- Must be 18 years or older.
- Must have a good overall health status.
- Must have normal levels of potassium and magnesium, with supplements allowed if needed.
- Must have adequate blood cell counts and kidney function.
- Must not have had previous radiation that overlaps with the current treatment area.
- Must not be taking certain medications that could interfere with the study.
- Must not have had surgery that removed all visible cancer.
- Must not have other serious health conditions that could affect participation.
- Women of childbearing potential must agree to use effective contraception during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Arizona Center for Cancer Care-Peoria | 85381 | Peoria | Arizona |
| Arizona Center for Cancer Care - Phoenix | 85027 | Phoenix | Arizona |
| Arizona Center for Cancer Care - Scottsdale | 85258 | Scottsdale | Arizona |
| Keck Medicine of USC Buena Park | 90621 | Buena Park | California |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| USC Norris Oncology/Hematology-Newport Beach | 92663 | Newport Beach | California |
| OSF Saint Joseph Medical Center | 61701 | Bloomington | Illinois |
| Illinois CancerCare-Bloomington | 61704 | Bloomington | Illinois |
| Illinois CancerCare-Canton | 61520 | Canton | Illinois |
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