MucositisPhase 2NCT03480971
Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
A Phase 2 study testing Tempol in people with Mucositis and Nephrotoxicity, run by Matrix Biomed, Inc. at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis, Nephrotoxicity, Ototoxicity
- What is being tested?
- Tempol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 9 sitesUnited States
- Study dates
- 13 May 2019to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 17Show fewer
- 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 bilirubin ≤ 2 X (Upper limit normal) ULN Alanine amino transferase (ALT) and Aspartate aminotransferase (AST) ≤5 x ULN
- Renal:
- Serum creatinine ≤ ULN or, if > ULN calculated creatinine clearance (CrCl) ≥ 60 mL/min.
- Nutritional and metabolic:
- Urine Albumin < 3.0 mg/dl
Who cannot join
- 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 treatment;
- 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 beta), or systemic KGF (keratinocyte growth factor) during or within 14 days of starting treatment;
- 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;
Show all 16Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 8 recruiting
- Recruiting
UCSD
La Jolla, California, 92093
- Recruiting
Mercy Medical Center
Merced, California, 95340
- Active, not recruiting
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
- Recruiting
Central Coast Medical Oncology
Santa Maria, California, 93454
- Recruiting
Mission Hope Health Center
Santa Maria, California, 93454
- Recruiting
Seattle Cancer Care Alliance
Seattle, Washington, 98195
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
- Recruiting
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Double Blind, Placebo Controlled Dose Range Finding Study to Assess the Safety, Pharmacokinetics, and Efficacy of Tempol for the Reduction of Severe Mucositis in Head and Neck Cancer Patients Undergoing Combined Radio- and Chemotherapy
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.
Read the detailed description
One hundred and twenty (120) participants with head and neck cancer are scheduled to undergo combined radio- and chemotherapy (n = 120).
Nearly all (90% to 97%) participants receiving radiotherapy in the head and neck will develop some degree of mucositis. Of these participants treated with radiotherapy with or without chemotherapy, 34% to 43% will present severe mucositis. As a result, the participant's quality of life is affected, hospital admittance rates are higher, the use of total parenteral nutrition is increased and interruption of treatment is more frequent, all of which compromise tumor control. Mucositis causes 9% to 19% of chemotherapy and radiotherapy interruption.
A common chemotherapeutic agent used in head and neck cancer is Cisplatin. Cisplatin (cis- diamminedichloroplatinum(II), CDDP) is an antineoplastic drug used in the treatment of many cancers including testicular cancer, ovarian cancer, bladder cancer, head and neck cancer, esophageal cancer, small and non-small cell lung cancer, breast cancer, cervical cancer, stomach cancer, prostate cancer, brain tumors, neuroblastoma, sarcomas, multiple myeloma, melanoma, mesothelioma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, pancreatic cancer, and thyroid cancer. While toxicities include ototoxicity, gastrotoxicity, myelosuppression, and allergic reactions, the main dose-limiting side effect of cisplatin is nephrotoxicity followed by ototoxicity.
Tempol is a piperidine nitroxide. Nitroxides are a class of stable free radical compounds that protects mammalian cells against numerous toxic agents. Tempol protects normal cells from radiation and cisplatin-induced damage; however, in cancerous or tumor cells, Tempol is reduced to its hydroxylamine form that does not and cannot protect the cells from radiation and cisplatin induced damage. This distinction is of particular importance in the setting of cancer treatment, in which both normal and tumor tissue is exposed to radiation and chemotherapy.
Without using Tempol, both normal cells and cancer cells suffer from toxicity. Tempol is the only known compound to possess this functional duality. This compound has the potential to prevent many of the toxicities associated with cisplatin and radiation treatment including the prevention of mucositis, nephrotoxicity, and ototoxicity.
- Conditions
- Mucositis, Nephrotoxicity, Ototoxicity
- Being tested
- Tempol, Placebo Solution
- Keywords
- cisplatin toxicity
- Medical subject headings
- Mucositis, Ototoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TempolDrug
Also called 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl
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 SolutionDrug
The placebo contains the same excipients as the active product plus FD\&C Yellow #6 for color matching.
| Study group | Role | What they receive |
|---|---|---|
| Active 1000 mg Tempol Solution | Active comparator | Patients will take 1000 mg of Tempol a day for the duration of radiation treatment (6-8 weeks) Receives: Drug: Tempol |
| Placebo Solution | Placebo comparator | Patients will take placebo solution everyday for the duration of radiation treatment (6-8 weeks) Receives: Drug: Placebo Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucositis
To determine the efficacy of Tempol in reducing the incidence severe mucositis defined as grade 3 or 4 on the World Health Organization (WHO) scale.
The incidence will measure the number of patients who experience grade 3 or 4 mucositis according to the World Health Organization (WHO) scale. A reduction in the number of patients who receive grade 3 or 4 mucositis over the course of the treatment is considered a positive change in incidence.
Measured: 10 weeks
Secondary outcomes (4)
Mucositis
To determine the efficacy of Tempol in reducing the duration severe mucositis defined as grade 3 or 4 on the World Health Organization (WHO) scale.
This duration will be measured by total number of days number a patient experiences grade 3 or 4 mucositis according to the World Health Organization (WHO) scale. A reduction in the total number of days a patient receives grade 3 or 4 mucositis over the course of the treatment is considered a positive change in duration.
Measured: 10 weeks
Nephrotoxicity
Reduction in Serum Creatinine levels in active arm versus placebo arm.
Measured: 10 weeks
Nephrotoxicity
Reduction in Blood Urea Nitrogen levels in active arm versus placebo arm.
Measured: 10 weeks
Mucositis
To determine the efficacy of Tempol in reducing the time to onset of grades 1-4 mucositis on the World Health Organization (WHO) scale.
This time to onset will measure the number of days after exposure to cisplatin before a patient experiences grade 1 through 4 mucositis according to the World Health Organization (WHO) scale. An increase in the total number of days before a patient receives grade 1 through 4 mucositis after cisplatin exposure is considered a positive change in time to onset.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start13 May 2019
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matrix Biomed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benji Crane, Study director, Matrix Biomed, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480971
- Sponsor's protocol ID
- MBI-04-04
- Status last verified
- Nov 2024
- First submitted
- 8 Mar 2018
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arany I, Safirstein RL. Cisplatin nephrotoxicity. Semin Nephrol. 2003 Sep;23(5):460-4. doi: 10.1016/s0270-9295(03)00089-5.
PubMed 13680535Ahmed LA, Shehata NI, Abdelkader NF, Khattab MM. Tempol, a superoxide dismutase mimetic agent, ameliorates cisplatin-induced nephrotoxicity through alleviation of mitochondrial dysfunction in mice. PLoS One. 2014 Oct 1;9(10):e108889. doi: 10.1371/journal.pone.0108889. eCollection 2014.
PubMed 25271439Scully C, Sonis S, Diz PD. Oral mucositis. Oral Dis. 2006 May;12(3):229-41. doi: 10.1111/j.1601-0825.2006.01258.x.
PubMed 16700732Hartmann JT, Lipp HP. Toxicity of platinum compounds. Expert Opin Pharmacother. 2003 Jun;4(6):889-901. doi: 10.1517/14656566.4.6.889.
PubMed 12783586Sastry J, Kellie SJ. Severe neurotoxicity, ototoxicity and nephrotoxicity following high-dose cisplatin and amifostine. Pediatr Hematol Oncol. 2005 Jul-Aug;22(5):441-5. doi: 10.1080/08880010590964381.
PubMed 16020136Samuni A, Winkelsberg D, Pinson A, Hahn SM, Mitchell JB, Russo A. Nitroxide stable radicals protect beating cardiomyocytes against oxidative damage. J Clin Invest. 1991 May;87(5):1526-30. doi: 10.1172/JCI115163.
PubMed 1850756Samuni A, Mitchell JB, DeGraff W, Krishna CM, Samuni U, Russo A. Nitroxide SOD-mimics: modes of action. Free Radic Res Commun. 1991;12-13 Pt 1:187-94. doi: 10.3109/10715769109145785.
PubMed 1649088Samuni A, Krishna CM, Mitchell JB, Collins CR, Russo A. Superoxide reaction with nitroxides. Free Radic Res Commun. 1990;9(3-6):241-9. doi: 10.3109/10715769009145682.
PubMed 2167262Mitchell JB, Anver MR, Sowers AL, Rosenberg PS, Figueroa M, Thetford A, Krishna MC, Albert PS, Cook JA. The antioxidant tempol reduces carcinogenesis and enhances survival in mice when administered after nonlethal total body radiation. Cancer Res. 2012 Sep 15;72(18):4846-55. doi: 10.1158/0008-5472.CAN-12-1879. Epub 2012 Jul 17.
PubMed 22805306
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled Dose Range Finding Study to Assess the Safety, Pharmacokinetics, and Efficacy of Tempol for the Reduction of Severe Mucositis in Head and Neck Cancer Patients Undergoing Combined Radio- and Chemotherapy
- ClinicalTrials.gov ID
- NCT03480971
- Acronym / sponsor ID
- MBI-04-04
- Conditions
- Mucositis, Nephrotoxicity, Ototoxicity
- Keywords
- cisplatin toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Matrix Biomed, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 May 2019 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
One hundred and twenty (120) participants with head and neck cancer are scheduled to undergo combined radio- and chemotherapy (n = 120).
Nearly all (90% to 97%) participants receiving radiotherapy in the head and neck will develop some degree of mucositis. Of these participants treated with radiotherapy with or without chemotherapy, 34% to 43% will present severe mucositis. As a result, the participant's quality of life is affected, hospital admittance rates are higher, the use of total parenteral nutrition is increased and interruption of treatment is more frequent, all of which compromise tumor control. Mucositis causes 9% to 19% of chemotherapy and radiotherapy interruption.
A common chemotherapeutic agent used in head and neck cancer is Cisplatin. Cisplatin (cis- diamminedichloroplatinum(II), CDDP) is an antineoplastic drug used in the treatment of many cancers including testicular cancer, ovarian cancer, bladder cancer, head and neck cancer, esophageal cancer, small and non-small cell lung cancer, breast cancer, cervical cancer, stomach cancer, prostate cancer, brain tumors, neuroblastoma, sarcomas, multiple myeloma, melanoma, mesothelioma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, pancreatic cancer, and thyroid cancer. While toxicities include ototoxicity, gastrotoxicity, myelosuppression, and allergic reactions, the main dose-limiting side effect of cisplatin is nephrotoxicity followed by ototoxicity.
Tempol is a piperidine nitroxide. Nitroxides are a class of stable free radical compounds that protects mammalian cells against numerous toxic agents. Tempol protects normal cells from radiation and cisplatin-induced damage; however, in cancerous or tumor cells, Tempol is reduced to its hydroxylamine form that does not and cannot protect the cells from radiation and cisplatin induced damage. This distinction is of particular importance in the setting of cancer treatment, in which both normal and tumor tissue is exposed to radiation and chemotherapy.
Without using Tempol, both normal cells and cancer cells suffer from toxicity. Tempol is the only known compound to possess this functional duality. This compound has the potential to prevent many of the toxicities associated with cisplatin and radiation treatment including the prevention of mucositis, nephrotoxicity, and ototoxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active 1000 mg Tempol Solution | Active comparator | Drug: TempolPatients will take 1000 mg of Tempol a day for the duration of radiation treatment (6-8 weeks) |
| Placebo Solution | Placebo comparator | Drug: Placebo SolutionPatients will take placebo solution everyday for the duration of radiation treatment (6-8 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (16 listed)
- 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 treatment;
- 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 beta), or systemic KGF (keratinocyte growth factor) during or within 14 days of starting treatment;
- Be taking mugard;
- Be taking prostaglandins, pentoxifylline or leucovorin during or within 14 days of starting treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TempolAlso: 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxylInvestigational 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. | Drug | Active 1000 mg Tempol Solution |
| Placebo SolutionThe placebo contains the same excipients as the active product plus FD\&C Yellow #6 for color matching. | Drug | Placebo Solution |
Primary outcome
Mucositis
Time frame: 10 weeks
To determine the efficacy of Tempol in reducing the incidence severe mucositis defined as grade 3 or 4 on the World Health Organization (WHO) scale. The incidence will measure the number of patients who experience grade 3 or 4 mucositis according to the World Health Organization (WHO) scale. A reduction in the number of patients who receive grade 3 or 4 mucositis over the course of the treatment is considered a positive change in incidence.
4 secondary outcomes
Mucositis
Time frame: 10 weeks
Nephrotoxicity
Time frame: 10 weeks
Nephrotoxicity
Time frame: 10 weeks
Mucositis
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 13680535Arany I, Safirstein RL. Cisplatin nephrotoxicity. Semin Nephrol. 2003 Sep;23(5):460-4. doi: 10.1016/s0270-9295(03)00089-5.
- Background: PubMed 25271439Ahmed LA, Shehata NI, Abdelkader NF, Khattab MM. Tempol, a superoxide dismutase mimetic agent, ameliorates cisplatin-induced nephrotoxicity through alleviation of mitochondrial dysfunction in mice. PLoS One. 2014 Oct 1;9(10):e108889. doi: 10.1371/journal.pone.0108889. eCollection 2014.
- Background: PubMed 16700732Scully C, Sonis S, Diz PD. Oral mucositis. Oral Dis. 2006 May;12(3):229-41. doi: 10.1111/j.1601-0825.2006.01258.x.
- Background: PubMed 12783586Hartmann JT, Lipp HP. Toxicity of platinum compounds. Expert Opin Pharmacother. 2003 Jun;4(6):889-901. doi: 10.1517/14656566.4.6.889.
- Background: PubMed 16020136Sastry J, Kellie SJ. Severe neurotoxicity, ototoxicity and nephrotoxicity following high-dose cisplatin and amifostine. Pediatr Hematol Oncol. 2005 Jul-Aug;22(5):441-5. doi: 10.1080/08880010590964381.
- Background: PubMed 1850756Samuni A, Winkelsberg D, Pinson A, Hahn SM, Mitchell JB, Russo A. Nitroxide stable radicals protect beating cardiomyocytes against oxidative damage. J Clin Invest. 1991 May;87(5):1526-30. doi: 10.1172/JCI115163.
- Background: PubMed 1649088Samuni A, Mitchell JB, DeGraff W, Krishna CM, Samuni U, Russo A. Nitroxide SOD-mimics: modes of action. Free Radic Res Commun. 1991;12-13 Pt 1:187-94. doi: 10.3109/10715769109145785.
- Background: PubMed 2167262Samuni A, Krishna CM, Mitchell JB, Collins CR, Russo A. Superoxide reaction with nitroxides. Free Radic Res Commun. 1990;9(3-6):241-9. doi: 10.3109/10715769009145682.
- Background: PubMed 22805306Mitchell JB, Anver MR, Sowers AL, Rosenberg PS, Figueroa M, Thetford A, Krishna MC, Albert PS, Cook JA. The antioxidant tempol reduces carcinogenesis and enhances survival in mice when administered after nonlethal total body radiation. Cancer Res. 2012 Sep 15;72(18):4846-55. doi: 10.1158/0008-5472.CAN-12-1879. Epub 2012 Jul 17.
- Individual participant dataSharing planned: Undecided
Related trials for Mucositis
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benji Crane study director
Matrix Biomed, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tempol in people with Mucositis and Nephrotoxicity, run by Matrix Biomed, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benji Crane (6264376506, bjcrane@matrixbiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucositis (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480971, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.