Oral MucositisPhase 2/3NCT04995354
Efficacy of EGF-loaded Self Healing Gel in Treatment of Oral Mucositis
A Phase 2/3 study testing EGF loaded Hydrogel and Hydrogel in people with Oral Mucositis, run by Cairo University.
Trial summary
Cancer treatment, including radiation along with aggressive chemotherapy, increases the patient's survival rate. However, they possess toxic side effects. Oral mucositis is one of the most serious complications of cancer treatment, which occurs in most of patients receiving cancer therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- EGF loaded Hydrogel and Hydrogel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 30 Dec 2022
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients are those over 18 years of age with WHO grade 3 or 4 oral mucositis receiving radio- or chemotherapy as treatment for head and neck cancer.
Who cannot join
- Patients with hematologic malignancies or those with known allergic reactions to the drug.
Trial locations and contacts
No sites are listed yet.
Mai Zakaria, PhD contact
About this study
Official title: Self Healing Gel as a Vehicle for Recombinant Human Epidermal Growth Factor in Treatment of Oral Mucositis Following Cancer Therapy
Cancer treatment, including radiation along with aggressive chemotherapy, increases the patient's survival rate. However, they possess toxic side effects. Oral mucositis is one of the most serious complications of cancer treatment, which occurs in most of patients receiving cancer therapy. Mucositis can dramatically affect the patient's quality of life .Epidermal growth factor (EGF) is a dominant factor in early keratinocyte differentiation, proliferation and migration. However, a major obstacle in most studies is that there isn't prolonged contact between the applied treatment and the oral mucosa to achieve the optimum therapeutic effect. Thus, a new vehicle for EGF is needed to achieve sufficient prolonged contact with oral mucosa. The present project aims at employing EGF as therapeutic agent for mucositis dealing with the challenges of delivery of such macromolecule to the oral mucosa by using self-healing gels to maximize the drug effect.
- Conditions
- Oral Mucositis
- Being tested
- EGF loaded Hydrogel, Hydrogel
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGF loaded HydrogelDrug
Also called Epidermal Growth Factor-loaded Hydrogel
Patients will receive 25 Ug/day of EGF. This is the estimated daily dose that will be obtained when the patient applies the gel thrice daily. Patients will receive the treatment for one week
HydrogelDrug
Also called Self-healing Hydrogel
Non-medicated self-healing hydrogel to be applied three times a day for 1 week
| Study group | Role | What they receive |
|---|---|---|
| EGF loaded Hydrogel (Gp I) | Experimental | 30 patients will receive EGF loaded Hydrogel (Intervention 1) to be applied three times a day for 1weeks. Receives: Drug: EGF loaded Hydrogel |
| Hydrogel alone ( Gp II) | Active comparator | 30 patients will receive Hydrogel alone (Intervention 2) to be applied three times a day for 2 weeks. Receives: Drug: Hydrogel |
| Control (Gp III) | No intervention | 30 patients will receive the standard of care treatment (Control) which includes benzydamine mouthwash, increased hydration, topical analgesics and antifungals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The European Organization for Research and Treatment of Cancer Quality of Life questionnaire
Questionnaire developed to assess the quality of life of cancer patients. The questionnaire used will be for that for head and neck patients (EORTC QLQ - H\&N43) https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-HN43-English.pdf
Measured: Baseline
WHO grade of mucositis
Grade 1 Soreness, with or without erythema
Grade 2 Erythema, ulcers; still able to swallow solid foods
Grade 3 Ulcers with extensive erythema; unable to swallow solid foods
Grade 4 Ulcers with extensive erythema; alimentation not possible
Measured: Baseline
The European Organization for Research and Treatment of Cancer Quality of Life questionnaire
Questionnaire developed to assess the quality of life of cancer patients. The questionnaire used will be for that for head and neck patients (EORTC QLQ - H\&N43) https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-HN43-English.pdf
Measured: After 7 days of treatment
WHO grade of mucositis
Grade 1 Soreness, with or without erythema
Grade 2 Erythema, ulcers; still able to swallow solid foods
Grade 3 Ulcers with extensive erythema; unable to swallow solid foods
Grade 4 Ulcers with extensive erythema; alimentation not possible
Measured: After 7 days of treatment
The European Organization for Research and Treatment of Cancer Quality of Life questionnaire
Questionnaire developed to assess the quality of life of cancer patients. The questionnaire used will be for that for head and neck patients (EORTC QLQ - H\&N43) https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-HN43-English.pdf
Measured: After 14 days of treatment.
WHO grade of mucositis
Grade 1 Soreness, with or without erythema
Grade 2 Erythema, ulcers; still able to swallow solid foods
Grade 3 Ulcers with extensive erythema; unable to swallow solid foods
Grade 4 Ulcers with extensive erythema; alimentation not possible
Measured: After 14 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Jun 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Elsaadany, Cairo University
- Investigators
- Basma AA Zakaria, PhD, Principal investigator, Lecturer at the Faculty of Dentistry - Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995354
- Sponsor's protocol ID
- MucoCU
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Healing Gel as a Vehicle for Recombinant Human Epidermal Growth Factor in Treatment of Oral Mucositis Following Cancer Therapy
- ClinicalTrials.gov ID
- NCT04995354
- Acronym / sponsor ID
- MucoCU
- Conditions
- Oral Mucositis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 6 Aug 2021 (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.
Cancer treatment, including radiation along with aggressive chemotherapy, increases the patient's survival rate. However, they possess toxic side effects. Oral mucositis is one of the most serious complications of cancer treatment, which occurs in most of patients receiving cancer therapy. Mucositis can dramatically affect the patient's quality of life .Epidermal growth factor (EGF) is a dominant factor in early keratinocyte differentiation, proliferation and migration. However, a major obstacle in most studies is that there isn't prolonged contact between the applied treatment and the oral mucosa to achieve the optimum therapeutic effect. Thus, a new vehicle for EGF is needed to achieve sufficient prolonged contact with oral mucosa. The present project aims at employing EGF as therapeutic agent for mucositis dealing with the challenges of delivery of such macromolecule to the oral mucosa by using self-healing gels to maximize the drug effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EGF loaded Hydrogel (Gp I) | Experimental | Drug: EGF loaded Hydrogel30 patients will receive EGF loaded Hydrogel (Intervention 1) to be applied three times a day for 1weeks. |
| Hydrogel alone ( Gp II) | Active comparator | Drug: Hydrogel30 patients will receive Hydrogel alone (Intervention 2) to be applied three times a day for 2 weeks. |
| Control (Gp III) | No intervention | –30 patients will receive the standard of care treatment (Control) which includes benzydamine mouthwash, increased hydration, topical analgesics and antifungals. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients are those over 18 years of age with WHO grade 3 or 4 oral mucositis receiving radio- or chemotherapy as treatment for head and neck cancer.
Key exclusion criteria (1 listed)
- Patients with hematologic malignancies or those with known allergic reactions to the drug.
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 |
|---|---|---|
| EGF loaded HydrogelAlso: Epidermal Growth Factor-loaded HydrogelPatients will receive 25 Ug/day of EGF. This is the estimated daily dose that will be obtained when the patient applies the gel thrice daily. Patients will receive the treatment for one week | Drug | EGF loaded Hydrogel (Gp I) |
| HydrogelAlso: Self-healing HydrogelNon-medicated self-healing hydrogel to be applied three times a day for 1 week | Drug | Hydrogel alone ( Gp II) |
Primary outcome
The European Organization for Research and Treatment of Cancer Quality of Life questionnaire
Time frame: Baseline
Questionnaire developed to assess the quality of life of cancer patients. The questionnaire used will be for that for head and neck patients (EORTC QLQ - H\&N43) https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-HN43-English.pdf
WHO grade of mucositis
Time frame: Baseline
Grade 1 Soreness, with or without erythema Grade 2 Erythema, ulcers; still able to swallow solid foods Grade 3 Ulcers with extensive erythema; unable to swallow solid foods Grade 4 Ulcers with extensive erythema; alimentation not possible
The European Organization for Research and Treatment of Cancer Quality of Life questionnaire
Time frame: After 7 days of treatment
Questionnaire developed to assess the quality of life of cancer patients. The questionnaire used will be for that for head and neck patients (EORTC QLQ - H\&N43) https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-HN43-English.pdf
WHO grade of mucositis
Time frame: After 7 days of treatment
Grade 1 Soreness, with or without erythema Grade 2 Erythema, ulcers; still able to swallow solid foods Grade 3 Ulcers with extensive erythema; unable to swallow solid foods Grade 4 Ulcers with extensive erythema; alimentation not possible
The European Organization for Research and Treatment of Cancer Quality of Life questionnaire
Time frame: After 14 days of treatment.
Questionnaire developed to assess the quality of life of cancer patients. The questionnaire used will be for that for head and neck patients (EORTC QLQ - H\&N43) https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-HN43-English.pdf
WHO grade of mucositis
Time frame: After 14 days of treatment.
Grade 1 Soreness, with or without erythema Grade 2 Erythema, ulcers; still able to swallow solid foods Grade 3 Ulcers with extensive erythema; unable to swallow solid foods Grade 4 Ulcers with extensive erythema; alimentation not possible
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Mai Zakaria, PhD contact
Basma AA Zakaria, PhD principal investigator
Lecturer at the Faculty of Dentistry - Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EGF loaded Hydrogel and Hydrogel in people with Oral Mucositis, run by Cairo University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha A Azab, PhD (01001381954, noha.adel@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The European Organization for Research and Treatment of Cancer Quality of Life questionnaire (time frame: Baseline). The study lists 6 primary outcomes in all. 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 6 Aug 2021.