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Tempol for Treatment Toxicities

Phase 2
Recruiting
Research Sponsored by Matrix Biomed, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks

Summary

This trial tests Tempol in head and neck cancer patients to see if it can reduce side effects from radiation and chemotherapy. Tempol protects healthy cells but not cancer cells, potentially reducing issues like mouth sores, kidney damage, and hearing loss.

Who is the study for?
This trial is for adults over 18 with squamous cell cancer of the head and neck, undergoing cisplatin chemotherapy and radiotherapy. They must have good kidney function, not be pregnant or breastfeeding, use effective birth control if applicable, and not have a history of certain conditions like HIV or insulin-dependent diabetes.
What is being tested?
The study tests Tempol's effectiveness in preventing/reducing side effects from cisplatin and radiation therapy in head and neck cancer patients. Over 10 weeks, it will compare Tempol to a placebo solution while monitoring mucositis (mouth sores), kidney damage, and hearing loss.
What are the potential side effects?
Potential side effects are not detailed here but may include reactions similar to those seen with other antioxidants used during chemotherapy such as nausea, headache, fatigue or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Mucositis
Nephrotoxicity

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active 1000 mg Tempol SolutionActive Control1 Intervention
Patients will take 1000 mg of Tempol a day for the duration of radiation treatment (6-8 weeks)
Group II: Placebo SolutionPlacebo Group1 Intervention
Patients will take placebo solution everyday for the duration of radiation treatment (6-8 weeks)

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Who is running the clinical trial?

Matrix Biomed, Inc.Lead Sponsor
5 Previous Clinical Trials
130 Total Patients Enrolled
Benji CraneStudy DirectorMatrix Biomed, Inc.
~12 spots leftby Jul 2025
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