Treatment of Radiation and Cisplatin Induced Toxicities with Tempol

Conditions

• Mucositis
• Nephrotoxicity
• Ototoxicity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tempol — DRUG
  Investigational product is Tempol (4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl) oral solution. Tempol solution is an orange-colored, aqueous solution containing 7% Tempol along with xanthan gum, xylitol, aspartame, acesulfame potassium, sodium saccharin, alcohol, peppermint and wintergreen oils.
• Placebo Solution — DRUG
  The placebo contains the same excipients as the active product plus FD\&C Yellow #6 for color matching.

Study Details

A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients. Over the course of the 10 week trial, mucositis, nephrotoxicity, and ototoxicity will be monitored and assessed.

Key Dates

Start date

May 13, 2019

Status verified

Nov 2024

Primary completion

Jul 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Active 1000 mg Tempol Solution
  Patients will take 1000 mg of Tempol a day for the duration of radiation treatment (6-8 weeks)
• Placebo Comparator: Placebo Solution
  Patients will take placebo solution everyday for the duration of radiation treatment (6-8 weeks)

Primary Outcome Measure

Mucositis [ Time Frame: 10 weeks ]

Central Contacts

• Benji Crane
  6264376506
  [email protected]

Locations (9)

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