Cisplatin nephrotoxicity.
Istvan Arany, Robert L Safirstein
https://pubmed.ncbi.nlm.nih.gov/13680535Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID03480971
A Double Blind, Placebo Controlled Study to Assess Safety, Pharmacokinetics, and Efficacy of Tempol for Reducing Severe Mucositis in Head and Neck Cancer Patients Undergoing Combined Radio- and Chemotherapy
Led by Matrix Biomed, Inc. · Updated on 2024-11-20
120
Participants Needed
9
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of Tempol to prevent or reduce side effects caused by cisplatin chemotherapy and radiation treatment in patients with head and neck cancer. The trial focuses on toxicities such as mucositis, nephrotoxicity, and ototoxicity, which commonly affect patients undergoing these treatments. This Phase 2 study involves 120 participants and aims to improve quality of life and treatment continuity by addressing these complications. Participants will be randomly assigned to receive either 1000 mg of Tempol oral solution or a placebo daily during their radiation therapy, which lasts about 6 to 8 weeks. Tempol is a compound that protects healthy cells without shielding cancer cells from treatment damage. Both groups will be monitored for the development and severity of mucositis, kidney damage, and hearing loss throughout the 10-week study period. During the study, participants will undergo regular assessments to track mucositis, kidney function, and hearing ability. Researchers will evaluate the safety, pharmacokinetics, and effectiveness of Tempol in reducing severe mucositis and other toxicities. Follow-up will include monitoring for adverse effects and overall health status. The trial lasts approximately 10 weeks, covering the treatment and observation periods.
CONDITIONS
Brief Title
Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older with medically diagnosed squamous cell cancer of the head and neck (SCCHN)
- Scheduled to receive radiotherapy or proton therapy with curative intent
- If female and of childbearing potential, use effective birth control with reliable history
- If male and of childbearing potential, use adequate contraception including condoms with spermicide; no sperm donation for 90 days after study
- Receiving cisplatin chemotherapy
- Provide informed consent and comply with study procedures
- ECOG performance status score of 2 or less
- Life expectancy of 6 months or longer
- Adequate baseline organ function including specific blood counts, liver enzymes, kidney function, and nutritional status
You will not qualify if you...
- Prior radiotherapy of the head and neck
- Active significant infection requiring therapy within 14 days before treatment
- Use of non-approved therapies for oral mucositis within 14 days before treatment
- Use of mugard, prostaglandins, pentoxifylline, or leucovorin within 14 days before treatment
- Use of certain mouthwashes (allopurinol, hydrogen peroxide, sucralfate, chlorhexidine) within 14 days before treatment
- Recent serious non-malignant medical complications making participation unsuitable
- Use of investigational drugs within 28 days before treatment
- History of positive HIV blood test
- Significant active medical illness precluding study completion
- Treatment plans including chemoradiation followed by further chemotherapy
- Body weight less than 35 kg (77 lbs)
- Pregnant or breastfeeding women
- Known intolerance to platinum drugs
- History of insulin-dependent diabetes mellitus
- Hepatitis B or C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 to 8 weeks
Participants receive either Tempol or placebo daily during their combined radiation and cisplatin chemotherapy treatment for head and neck cancer.
Daily medication administration with regular clinical visits during treatment
Trial Site Locations
Total: 9 locations
1
UCSD
La Jolla, California, United States, 92093
Actively Recruiting
2
Mercy Medical Center
Merced, California, United States, 95340
Actively Recruiting
3
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Active, Not Recruiting
4
Central Coast Medical Oncology
Santa Maria, California, United States, 93454
Actively Recruiting
5
Mission Hope Health Center
Santa Maria, California, United States, 93454
Actively Recruiting
6
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
Actively Recruiting
7
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
8
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98195
Actively Recruiting
9
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
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Research Team
B
Benji Crane
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Tempol, a superoxide dismutase mimetic agent, ameliorates cisplatin-induced nephrotoxicity through alleviation of mitochondrial dysfunction in mice.
Lamiaa A Ahmed, Nagwa I Shehata, Noha F Abdelkader...
https://pubmed.ncbi.nlm.nih.gov/25271439Oral mucositis.
C Scully, S Sonis, P D Diz
https://pubmed.ncbi.nlm.nih.gov/16700732Toxicity of platinum compounds.
Jörg Thomas Hartmann, Hans-Peter Lipp
https://pubmed.ncbi.nlm.nih.gov/12783586Severe neurotoxicity, ototoxicity and nephrotoxicity following high-dose cisplatin and amifostine.
Jairam Sastry, Stewart J Kellie
https://pubmed.ncbi.nlm.nih.gov/16020136Nitroxide stable radicals protect beating cardiomyocytes against oxidative damage.
A Samuni, D Winkelsberg, A Pinson...
https://pubmed.ncbi.nlm.nih.gov/1850756Nitroxide SOD-mimics: modes of action.
A Samuni, J B Mitchell, W DeGraff...
https://pubmed.ncbi.nlm.nih.gov/1649088Superoxide reaction with nitroxides.
A Samuni, C M Krishna, J B Mitchell...
https://pubmed.ncbi.nlm.nih.gov/2167262The antioxidant tempol reduces carcinogenesis and enhances survival in mice when administered after nonlethal total body radiation.
James B Mitchell, Miriam R Anver, Anastasia L Sowers...
https://pubmed.ncbi.nlm.nih.gov/22805306