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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 ≥18 years of age with medically diagnosed squamous cell cancer of the head and neck (SCCHN);
Must be receiving cisplatin for chemotherapy;
Must not have
Prior radiotherapy of the head and neck;
Participants with body weight less than 35 kg, 77 lbs;
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with a diagnosis of head and neck cancer.
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I am currently being treated with cisplatin.
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I am scheduled for radiotherapy or proton therapy to cure my cancer.
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I can do most of my daily activities on my own.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had radiation therapy on my head or neck.
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My body weight is less than 35 kg (77 lbs).
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I am allergic or have had a bad reaction to platinum-based chemotherapy drugs.
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I have Hepatitis B or C.
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My treatment plan includes chemoradiation followed by more chemotherapy.
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I am not pregnant or breastfeeding.
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I have diabetes that requires insulin.
Select...
I am not using any non-approved treatments for mouth sores.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
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)
Find a Location
Who is running the clinical trial?
Matrix Biomed, Inc.Lead Sponsor
5 Previous Clinical Trials
130 Total Patients Enrolled
Benji CraneStudy DirectorMatrix Biomed, Inc.