A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation

Summary

This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Other
  Best Practice

  Receive usual symptom management

• Procedure
  Biospecimen Collection

  Undergo collection of blood, serum, and/or plasma samples

• Drug
  Cisplatin

  Given cisplatin

• Procedure
  Computed Tomography

  Undergo CT

• Radiation
  Image Guided Radiation Therapy

  Undergo image-guided radiation therapy

• Radiation
  Intensity-Modulated Radiation Therapy

  Undergo intensity-modulated radiation therapy

• Procedure
  Magnetic Resonance Imaging

Locations (149)