StomatitisPhase 2NCT03200340
EC-18 for Oral Mucositis in Patients With Concomitant Chemoirradiation
A Phase 2 study testing EC-18 in people with Stomatitis, run by Enzychem Lifesciences Corporation at 20 sites in United States.
Trial summary
This is a Phase 2, randomized, double-blind, placebo-controlled, 2-stage trial in subjects with squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx planned to receive standard fractionated IMRT-delivered radiotherapy with concomitant chemotherapy (cisplatin). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomatitis
- What is being tested?
- EC-18
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 20 sitesUnited States
- Study dates
- 3 Jul 2018to 14 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Signed informed consent
- Male or female age 18 years or older
- Pathologically confirmed diagnosis of squamous cell carcinoma of the mouth, oropharynx, hypopharynx or nasopharynx
- Planned to receive IMRT with daily fractions of 2.0 Gy to 2.2 Gy to a cumulative dose of at least 60 Gy and a maximum of 72 Gy
- Radiation fields to include at least two mucositis sites at risk (buccal mucosa, floor of mouth, ventral and lateral tongue, soft palate) in which both sites receive a minimum cumulative dose of 55 Gy
- Planned to receive concomitant single agent chemotherapy with cisplatin given either weekly or tri-weekly
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- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Screening Laboratory Values Hemoglobin ≥ 9g/dL White blood cell count ≥ 3,500 cells/mm3 Absolute neutrophil count ≥ 1,500 cells/mm3 Total bilirubin ≤ 2 times upper limit of normal Serum AST and ALT ≤ 2.5 times upper limit of normal Serum creatinine concentration ≤ 2mg/mL Pregnancy test: negative for females of childbearing potential
- Subjects of childbearing potential must consent to utilize a medically accepted means of contraception throughout the active dosing period with study medication and for a minimum of 30 days following the administration of the last dose of study medication.
Who cannot join
- Unable to provide informed consent or, in the opinion of the Principal Investigator, comply with the protocol.
- Prior radiation therapy to the head and neck
- Metastatic disease
- Presence of active infectious disease excluding oral candidiasis
- Presence of oral mucositis or any oral lesion that would confound the assessment of oral mucositis
- Active systemic disease or condition known to impact the risk or course of oral mucositis including chronic immunosuppression and known seropositivity for HIV
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- Use of any investigational agent within 30 days of the first radiation dose
- Active alcohol abuse syndrome
- Subjects with a history of hepatitis of any etiology or hepatic insufficiency
- Pregnant or nursing at the time of signing informed consent
- Known sensitivity to any study medication
- Unwilling or unable to complete study diary
- Any other condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the protocol
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
St. Luke's Cancer Center - Anderson Campus
Easton, Pennsylvania, 18045
NorthShore University HealthSystem
Evanston, Illinois, 60201
University of Kentucky, Chandler Medical Center, CCTS
Lexington, Kentucky, 40536
Veterans Affairs Long Beach Health Care System
Long Beach, California, 90822
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Miami Cancer Institute
Miami, Florida, 33176
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Mount Sinai - Union Square
New York, New York, 10003
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Oregon Health and Science University
Portland, Oregon, 97239
VA Portland HealthCare System
Portland, Oregon, 97239
MultiCare Institute for Research and Innovation
Spokane, Washington, 98405
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Washington University School of Medicine
St Louis, Missouri, 63110-1010
MultiCare Institute for Research and Innovation
Tacoma, Washington, 98405
Hope Cancer Center of East Texas
Tyler, Texas, 75701
Baylor Scott & White Medical Center - Hillcrest
Waco, Texas, 76712
Cancer Center of Kansas
Wichita, Kansas, 67214
About this study
Official title: Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate EC-18 for Oral Mucositis in Patients With Concomitant Chemoirradiation for Cancers of the Mouth, Oropharynx, Hypopharynx and Nasopharynx
This is a Phase 2, randomized, double-blind, placebo-controlled, 2-stage trial in subjects with squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx planned to receive standard fractionated IMRT-delivered radiotherapy with concomitant chemotherapy (cisplatin). Informed consent will be obtained from each subject prior to enrollment.
The trial will be performed in 2 stages:
Read more
Stage 1 will consist of a blinded parallel group safety study of 4 cohorts in which 24 subjects will be randomized (1:1:1:1) into four equally sized groups to receive one of three doses of EC-18 (500 mg, 1000 mg, 2000 mg; unit dose of 500 mg) or placebo. Stage 2 of the study will evaluate both safety and efficacy.
Stage 2 will consist of eighty (80) subjects who will be randomized in a 1:1 scheme to receive either placebo or 2000 mg of EC-18 as determined by iDSMB in Stage 1.
Read the detailed description
This is a Phase 2, randomized, double-blind, placebo-controlled, 2-stage trial in subjects with squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx planned to receive standard fractionated IMRT-delivered radiotherapy with concomitant chemotherapy (cisplatin). Informed consent will be obtained from each subject prior to enrollment.
The trial will be performed in 2 stages:
Stage 1 will consist of a blinded parallel group safety study of 4 cohorts in which 24 subjects will be randomized (1:1:1:1) into four equally sized groups to receive one of three doses of EC-18 (500 mg, 1000 mg, 2000 mg; unit dose of 500 mg) or placebo delivered in the following daily schedule:
TDD AM PM Placebo 2 placebo 2 placebo 500mg 1 active + 1 placebo 2 placebo 1000mg 1 active + 1 placebo 1 active + 1 placebo 2000mg 2 active 2 active Dosing will commence on the first day of radiation (one hour after the first fraction) and continue until the last day of radiation. Test drug will be administered as an oral 500 mg capsule in divided daily doses as indicated above. At the completion of 4 weeks of dosing, an independent Data Safety Monitoring Board (DSMB) will evaluate safety endpoints in blinded fashion. If no safety issues are identified, the DSMB will approve continuation of dosing until the last day of radiation. If a safety issue is noted, the DSMB may unblind the treatment assignment to ascertain if the adverse event is associated with study drug. DSMB assessment will be repeated after completion of dosing (when each subject has been dosed through the last day of radiation). If no safety issues are identified, the efficacy component of the study (Stage 2) will commence using the highest dose of study drug consistent with a positive safety outcome.
Stage 2 of the study will evaluate both safety and efficacy. Eighty (80) subjects will be randomized in a 1:1 scheme to receive either placebo or 2000 mg of EC-18 as determined by iDSMB in Stage 1. Twice daily dosing will begin on the first day of radiation (1 hour after the first fraction) and continue until the last day of radiation (approximately 7 weeks).
The study will be performed in four phases: screening, the active dosing phase, short-term follow-up and long-term follow-up. The screening phase will be performed within 4 weeks of randomization and will determine subjects' eligibility. The active phase will begin on the first day of study drug dosing (also the first day of radiation therapy) and will continue until the last day of radiation therapy. This period typically is 7 weeks depending on the subject's radiation plan. The short-term follow-up phase will begin on the last day of radiation and continue for approximately 4-6 weeks until clinical and symptomatic signs of oral mucositis have resolved. The long-term follow-up phase extends for 12 months following the last dose of radiation and is included to assure that EC-18 does not the impact of tumor response to treatment.
- Conditions
- Stomatitis
- Being tested
- EC-18, Placebo
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC-18Drug
Also called EC-18 soft capsules
Oral administration of EC-18 twice daily
PlaceboDrug
Also called Placebo capsule
Placebo to match EC-18 capsule administration
| Study group | Role | What they receive |
|---|---|---|
| [Part 1] Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
| [Part 1] EC-18 500 mg | Experimental | 1 capsule of EC-18 Receives: Drug: EC-18 |
| [Part 1] EC-18 1000 mg | Experimental | 2 capsules of EC-18 500 mg Receives: Drug: EC-18 |
| [Part 1] EC-18 2000 mg | Experimental | 4 capsules of EC-18 500 mg Receives: Drug: EC-18 |
| [Part 2] Placebo | Placebo comparator | Placebo 2000mg Receives: Drug: Placebo |
| [Part 2] EC-18 2000mg | Experimental | RP2D: EC-18 2000mg (Part 1 result) Receives: Drug: EC-18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Severe Oral Mucositis (SOM) during the active treatment and short-term follow-up periods
Duration of Grade 3 or 4 oral mucositis
Measured: 7 Weeks (Active) + 4-6 Weeks (STFU)
Secondary outcomes (8)
Duration of SOM during the active treatment period
Duration of Grade 3 or 4 oral mucositis
Measured: 7 Weeks (Active)
Incidence of severe oral mucositis defined as WHO grade of 3 or 4 during the active treatment period
Incidence of severe oral mucositis defined as WHO grade of 3 or 4
Measured: 7 Weeks (Active)
Incidence of severe oral mucositis defined as WHO grade of 3 or 4 during the active treatment and short-term follow-up periods
Incidence of severe oral mucositis defined as WHO grade of 3 or 4
Measured: 7 Weeks (Active) + 4-6 Weeks (STFU)
Incidence of ulcerative mucositis (defined as WHO grade of 2, 3, or 4) during the active treatment period
Incidence of WHO grade of 2, 3, or 4 ulcerative mucositis
Measured: 7 Weeks (Active)
Incidence of ulcerative mucositis (defined as WHO grade of 2, 3, or 4) during the active treatment and short-term follow-up periods
Incidence of WHO grade of 2, 3, or 4 ulcerative mucositis
Measured: 7 Weeks (Active) + 4-6 Weeks (STFU)
Duration of ulcerative mucositis (WHO criteria)
Duration of grade 3 or 4 ulcerative mucositis
Measured: From the onset to the day when ulcerative mucositis has resolved (up to 22 weeks)
Delay in onset of SOM (WHO criteria)
Time to onset of grade 3 or 4 severe oral mucositis
Measured: Start of the radiation treatment (Day 1) until SOM has resolved (up to 22 weeks)
Reduction in patient-reported mucositis-related mouth pain and analgesic use
Frequency of disease-related mouth pain and analgesic use
Measured: 7 Weeks (Active) + 4-6 Weeks (STFU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start3 Jul 2018
- Primary completion14 May 2021
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StomatitisStudies 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
- Sequential
- Model description
- 2 stages: Stage 1 is a blinded parallel group safety study of 4 cohorts of 24 subjects randomized (1:1:1:1) to receive either EC-18 500 mg, 1000 mg, 2000 mg, or placebo. Dosing will commence on the first day of radiation and continue until the last day of radiation. After of 4 weeks, an independent Data Safety Monitoring Board (DSMB) will evaluate safety endpoints in blinded fashion. DSMB assessment will be repeated after completion of dosing. Stage 2 of the study will evaluate both safety and efficacy. Eighty (80) subjects will be randomized in a 1:1 scheme to receive placebo or EC-18 at the dose determined in Stage 1. The design of stage 2 is the same as stage 1.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzychem Lifesciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Moon Shin, MD, Principal investigator, Emory University Winship Cancer InstituteMahesh Kudrimoti, MD, Principal investigator, University of Kentucky, Chandler Medical Center, CCTS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200340
- Sponsor's protocol ID
- EC-18-202
- Status last verified
- Jul 2023
- First submitted
- 13 Jun 2017
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate EC-18 for Oral Mucositis in Patients With Concomitant Chemoirradiation for Cancers of the Mouth, Oropharynx, Hypopharynx and Nasopharynx
- ClinicalTrials.gov ID
- NCT03200340
- Acronym / sponsor ID
- EC-18-202
- Conditions
- Stomatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Enzychem Lifesciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 27 Jun 2017 (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.
This is a Phase 2, randomized, double-blind, placebo-controlled, 2-stage trial in subjects with squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx planned to receive standard fractionated IMRT-delivered radiotherapy with concomitant chemotherapy (cisplatin). Informed consent will be obtained from each subject prior to enrollment.
The trial will be performed in 2 stages:
Stage 1 will consist of a blinded parallel group safety study of 4 cohorts in which 24 subjects will be randomized (1:1:1:1) into four equally sized groups to receive one of three doses of EC-18 (500 mg, 1000 mg, 2000 mg; unit dose of 500 mg) or placebo. Stage 2 of the study will evaluate both safety and efficacy.
Stage 2 will consist of eighty (80) subjects who will be randomized in a 1:1 scheme to receive either placebo or 2000 mg of EC-18 as determined by iDSMB in Stage 1.
Detailed description
This is a Phase 2, randomized, double-blind, placebo-controlled, 2-stage trial in subjects with squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx planned to receive standard fractionated IMRT-delivered radiotherapy with concomitant chemotherapy (cisplatin). Informed consent will be obtained from each subject prior to enrollment.
The trial will be performed in 2 stages:
Stage 1 will consist of a blinded parallel group safety study of 4 cohorts in which 24 subjects will be randomized (1:1:1:1) into four equally sized groups to receive one of three doses of EC-18 (500 mg, 1000 mg, 2000 mg; unit dose of 500 mg) or placebo delivered in the following daily schedule:
TDD AM PM Placebo 2 placebo 2 placebo 500mg 1 active + 1 placebo 2 placebo 1000mg 1 active + 1 placebo 1 active + 1 placebo 2000mg 2 active 2 active Dosing will commence on the first day of radiation (one hour after the first fraction) and continue until the last day of radiation. Test drug will be administered as an oral 500 mg capsule in divided daily doses as indicated above. At the completion of 4 weeks of dosing, an independent Data Safety Monitoring Board (DSMB) will evaluate safety endpoints in blinded fashion. If no safety issues are identified, the DSMB will approve continuation of dosing until the last day of radiation. If a safety issue is noted, the DSMB may unblind the treatment assignment to ascertain if the adverse event is associated with study drug. DSMB assessment will be repeated after completion of dosing (when each subject has been dosed through the last day of radiation). If no safety issues are identified, the efficacy component of the study (Stage 2) will commence using the highest dose of study drug consistent with a positive safety outcome.
Stage 2 of the study will evaluate both safety and efficacy. Eighty (80) subjects will be randomized in a 1:1 scheme to receive either placebo or 2000 mg of EC-18 as determined by iDSMB in Stage 1. Twice daily dosing will begin on the first day of radiation (1 hour after the first fraction) and continue until the last day of radiation (approximately 7 weeks).
The study will be performed in four phases: screening, the active dosing phase, short-term follow-up and long-term follow-up. The screening phase will be performed within 4 weeks of randomization and will determine subjects' eligibility. The active phase will begin on the first day of study drug dosing (also the first day of radiation therapy) and will continue until the last day of radiation therapy. This period typically is 7 weeks depending on the subject's radiation plan. The short-term follow-up phase will begin on the last day of radiation and continue for approximately 4-6 weeks until clinical and symptomatic signs of oral mucositis have resolved. The long-term follow-up phase extends for 12 months following the last dose of radiation and is included to assure that EC-18 does not the impact of tumor response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- 2 stages: Stage 1 is a blinded parallel group safety study of 4 cohorts of 24 subjects randomized (1:1:1:1) to receive either EC-18 500 mg, 1000 mg, 2000 mg, or placebo. Dosing will commence on the first day of radiation and continue until the last day of radiation. After of 4 weeks, an independent Data Safety Monitoring Board (DSMB) will evaluate safety endpoints in blinded fashion. DSMB assessment will be repeated after completion of dosing. Stage 2 of the study will evaluate both safety and efficacy. Eighty (80) subjects will be randomized in a 1:1 scheme to receive placebo or EC-18 at the dose determined in Stage 1. The design of stage 2 is the same as stage 1.
| Arm | Type | Receives |
|---|---|---|
| [Part 1] Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
| [Part 1] EC-18 500 mg | Experimental | Drug: EC-181 capsule of EC-18 |
| [Part 1] EC-18 1000 mg | Experimental | Drug: EC-182 capsules of EC-18 500 mg |
| [Part 1] EC-18 2000 mg | Experimental | Drug: EC-184 capsules of EC-18 500 mg |
| [Part 2] Placebo | Placebo comparator | Drug: PlaceboPlacebo 2000mg |
| [Part 2] EC-18 2000mg | Experimental | Drug: EC-18RP2D: EC-18 2000mg (Part 1 result) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent
- Male or female age 18 years or older
- Pathologically confirmed diagnosis of squamous cell carcinoma of the mouth, oropharynx, hypopharynx or nasopharynx
- Planned to receive IMRT with daily fractions of 2.0 Gy to 2.2 Gy to a cumulative dose of at least 60 Gy and a maximum of 72 Gy
- Radiation fields to include at least two mucositis sites at risk (buccal mucosa, floor of mouth, ventral and lateral tongue, soft palate) in which both sites receive a minimum cumulative dose of 55 Gy
Key exclusion criteria (13 listed)
- Unable to provide informed consent or, in the opinion of the Principal Investigator, comply with the protocol.
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 |
|---|---|---|
| EC-18Also: EC-18 soft capsulesOral administration of EC-18 twice daily | Drug | [Part 1] EC-18 1000 mg, [Part 1] EC-18 2000 mg, [Part 1] EC-18 500 mg, [Part 2] EC-18 2000mg |
| PlaceboAlso: Placebo capsulePlacebo to match EC-18 capsule administration | Drug | [Part 1] Placebo, [Part 2] Placebo |
Primary outcome
Duration of Severe Oral Mucositis (SOM) during the active treatment and short-term follow-up periods
Time frame: 7 Weeks (Active) + 4-6 Weeks (STFU)
Duration of Grade 3 or 4 oral mucositis
8 secondary outcomes
Duration of SOM during the active treatment period
Time frame: 7 Weeks (Active)
Incidence of severe oral mucositis defined as WHO grade of 3 or 4 during the active treatment period
Time frame: 7 Weeks (Active)
Incidence of severe oral mucositis defined as WHO grade of 3 or 4 during the active treatment and short-term follow-up periods
Time frame: 7 Weeks (Active) + 4-6 Weeks (STFU)
Incidence of ulcerative mucositis (defined as WHO grade of 2, 3, or 4) during the active treatment period
Time frame: 7 Weeks (Active)
Incidence of ulcerative mucositis (defined as WHO grade of 2, 3, or 4) during the active treatment and short-term follow-up periods
Time frame: 7 Weeks (Active) + 4-6 Weeks (STFU)
Duration of ulcerative mucositis (WHO criteria)
Time frame: From the onset to the day when ulcerative mucositis has resolved (up to 22 weeks)
Delay in onset of SOM (WHO criteria)
Time frame: Start of the radiation treatment (Day 1) until SOM has resolved (up to 22 weeks)
Reduction in patient-reported mucositis-related mouth pain and analgesic use
Time frame: 7 Weeks (Active) + 4-6 Weeks (STFU)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Stomatitis
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. This study is not recruiting at the moment.
Dong Moon Shin, MD principal investigator
Emory University Winship Cancer Institute
Mahesh Kudrimoti, MD principal investigator
University of Kentucky, Chandler Medical Center, CCTS
20 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 EC-18 in people with Stomatitis, run by Enzychem Lifesciences Corporation at 20 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 9 inclusion and 13 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: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Severe Oral Mucositis (SOM) during the active treatment and short-term follow-up periods (time frame: 7 Weeks (Active) + 4-6 Weeks (STFU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2023.