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New treatment option for Mucositis
Official title Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
ClinicalTrials.gov ID: NCT03480971
What this study is testing
What is Tempol?
Tempol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for mucositis.
Also referred to as 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be ≥18 years of age with medically diagnosed squamous cell cancer of the head and neck (SCCHN);
- Be scheduled to receive radiotherapy or proton therapy administered with a curative intent;
- If female and of child bearing potential, be using an effective birth-control method with a history of reliability for the individual participant;
- If male and of child bearing potential, adequate methods of contraception must be employed including use of condoms with spermicide. No sperm...
- Must be receiving cisplatin for chemotherapy;
You likely can't join if
- Prior radiotherapy of the head and neck;
- Have a clinically significant infection defined as any acute viral, bacterial or fungal infection, which requires specific therapy. Anti-infectious...
- Be taking any non-approved therapy for oral mucositis, including β-carotene, tocopherol, laser irradiation, brushing the oral mucosa with...
- Be taking mugard;
- Be taking prostaglandins, pentoxifylline or leucovorin during or within 14 days of starting treatment;
- Be rinsing with allopurinol, hydrogen peroxide, sucralfate, or chlorhexidine mouthwashes during or within 14 days of starting treatment;
See the full eligibility criteria
- Be ≥18 years of age with medically diagnosed squamous cell cancer of the head and neck (SCCHN);
- Be scheduled to receive radiotherapy or proton therapy administered with a curative intent;
- If female and of child bearing potential, be using an effective birth-control method with a history of reliability for the individual participant;
- If male and of child bearing potential, adequate methods of contraception must be employed including use of condoms with spermicide. No sperm donation for 90 days until after the conclusion of the study;
- Must be receiving cisplatin for chemotherapy;
- Be properly informed of the nature and risks of the clinical investigation, comply with all clinical investigation-related procedures, and sign an Informed Consent Form prior to entering the clinical investigation;
- Must have a score 2 or less on the ECOG performance status;
- Participant life expectancy ≥ 6 months; and
- Adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic): Haematology: Absolute neutrophil count (ANC) ≥1.5 Hemoglobin ≥ 10 g/dL Platelets ≥ 100,000 per microliter of blood Hepatic: Total...
- Prior radiotherapy of the head and neck;
- Have a clinically significant infection defined as any acute viral, bacterial or fungal infection, which requires specific therapy. Anti-infectious therapy must have been completed within 14 days of starting study...
- Be taking any non-approved therapy for oral mucositis, including β-carotene, tocopherol, laser irradiation, brushing the oral mucosa with silver-nitrate prophylactically, systemic TGF-β (transforming growth factor...
- Be taking mugard;
- Be taking prostaglandins, pentoxifylline or leucovorin during or within 14 days of starting treatment;
- Be rinsing with allopurinol, hydrogen peroxide, sucralfate, or chlorhexidine mouthwashes during or within 14 days of starting treatment;
- Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation;
- Have used an investigational drug within 28 days of the initiation of study treatment;
- Have a history of a positive blood test for HIV;
- At the time of screening, having a significant active medical illness which, in the opinion of the investigator, would preclude completion of the study;
- Participants with a treatment plan consisting of chemoradiation followed by further chemotherapy;
- Participants with body weight less than 35 kg, 77 lbs;
- Women who are pregnant or who are breastfeeding;
- Participants with known intolerance to platin drugs;
- History of insulin-dependent Diabetes Mellitus; and
- Participants with Hepatitis B/C.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Merced, California, United States
- San Francisco, California, United States
- Santa Maria, California, United States
- The Bronx, New York, United States
- Winston-Salem, North Carolina, United States
- Seattle, Washington, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Merced, California, United States; San Francisco, California, United States; Santa Maria, California, United States; The Bronx, New York, United States; Winston-Salem, North Carolina, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.