Radiotherapy Side EffectNCT06117904
Adjunctive Treatments for the Prevention of Radiotherapy-Induced Mucositis
A study testing MEBO ointment and Symptomatic treatment only in people with Radiotherapy Side Effect and Mucositis, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Radiation therapy (RT) is used in at least 50% of cancer patients and is critical in treating and palliating tumor-related symptoms. Normal tissue radiation toxicity remains an overwhelming obstacle in treating cancer patients with localized tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy Side Effect, Mucositis
- What is being tested?
- MEBO ointment and Symptomatic treatment only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jul 2024
- Phase
- Interventional
- 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
- Adults (>18 years) with histopathologically confirmed Head and Neck Cancer (HNC), primary tumor in the stages T1, T2, T3, or T4, a regional node of any N status, and distant metastases absent.
- All patients who were going to receive RT (dose between 60-70 Gy) on the head and neck region as postoperative (adjuvant) or definitive therapy. Either these patients had received chemotherapy prior or in concomitant to radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 to 2 and normal hematologic and biochemical parameters.
Who cannot join
- patients undergoing previous radiotherapy
- uncontrolled systemic or widely disseminated disease
- having any physical or mental abnormality,
- pregnant and lactating women
- presence of a synchronous double primary malignancy or simultaneous participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effects and Safety of MEBO as Add on Therapy for the Prevention of Radiotherapy-Induced Mucositis
Radiation therapy (RT) is used in at least 50% of cancer patients and is critical in treating and palliating tumor-related symptoms. Normal tissue radiation toxicity remains an overwhelming obstacle in treating cancer patients with localized tumors.
Mucositis is the inflammation and ulceration of the oral and gastrointestinal mucosa observed with different cancer therapies. Oral mucositis is a common, severe, and debilitating complication of RT occurring several days to weeks after RT initiation.
Read the detailed description
This study is a single blind randomized controlled clinical trial with a parallel-group design conducted in the clinical oncology department of Beni-Suef University Hospital.
A total of 50 patients with head and neck cancer receiving RT were randomly assigned into either study group:
Group 1 (Intervention group):
This group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks
Group 2 (Control group):
This group included twenty-five patients given symptomatic therapy 3 times daily for 7 weeks.
These therapies included anti-fungal agents (Miconaz oral gel), topical anesthetics and anti-inflammatory drugs (BBC oral spray), topical analgesic gel (Oracure gel), sodium bicarbonate mouthwash (Alkamisr sachets)
- Oral mucositis severity was measured by the World Health Organization Toxicity Scale (WHO grading system). Based on the symptomatic (oral pain), and functional clinical features of every patient (ability to drink and eat) as well as the presence of lesions (ulcers, erythema), the measurements were categorized to Grade I: presence of soreness and erythema, Grade II: presence of painful erythema and ulcerations that do not affect the patient solid food intake, Grade Ш: confluent ulceration that affect the solid food intake and require liquid diet, and Grade ΙV: the patient requires parenteral nutrition.
- Discomfort and pain severity were recorded using the Numeric Rating Scale (NRS), which is categorized to no pain (NRS 0), mild pain (NRS 1-3), moderate pain (NRS 4-7), and unbearable pain (NRS 8-10). Patients were asked to assign a numerical score on the scale verbally to rate their pain intensity, and the number was recorded
- Dry mouth, Dysphagia was measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care.
Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
- Conditions
- Radiotherapy Side Effect, Mucositis
- Being tested
- MEBO ointment, Symptomatic treatment only
- Medical subject headings
- Radiation Injuries, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEBO ointmentDrug
This group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks
Symptomatic treatment onlyDrug
This group included twenty-five patients given symptomatic therapy 3 times daily for 7 weeks.
These therapies included anti-fungal agents (Miconaz oral gel), topical anesthetics and anti-inflammatory drugs (BBC oral spray), topical analgesic gel (Oracure gel), sodium bicarbonate mouthwash (Alkamisr sachets).
| Study group | Role | What they receive |
|---|---|---|
| MEBO ointment + symptomatic therapy | Experimental | This group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks. Receives: Drug: MEBO ointment; Drug: Symptomatic treatment only |
| symptomatic therapy | Active comparator | This group included twenty-five patients given symptomatic therapy 3 times daily for 7 weeks.
These therapies included anti-fungal agents (Miconaz oral gel), topical anesthetics and anti-inflammatory drugs (BBC oral spray), topical analgesic gel (Oracure gel), sodium bicarbonate mouthwash (Alkamisr sachets). Receives: Drug: Symptomatic treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral mucositis Severity
Oral mucositis severity was measured by the World Health Organization Toxicity Scale (WHO grading system) Grade 1 Mild; asymptomatic Grade 2 Moderate; minimal, local inflammation Grade 3 Severe or medically significant Grade 4 Life-threatening Grade 5 Death
Measured: 7 weeks
Secondary outcomes (2)
Dry mouth, Dysphagia score
Dry mouth, Dysphagia was measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Grade 1: Symptomatic, able to eat regular diet Grade 2: Symptomatic and altered eating/swallowing Grade 3: Severely altered eating/swallowing; tube feeding, TPN, or hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death
Measured: 7 weeks
Discomfort and pain severity
Discomfort and pain severity were recorded using the Numeric Rating Scale (NRS) Grade 1: Mild pain Grade 2: Moderate pain Grade 3: Severe pain
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jan 2024
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radiotherapy Side EffectStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Sohag University
- Responsible party
- Principal investigator, Asmaa Abdelfattah Elsayed, Beni-Suef University
- Investigators
- Engy Wahsh, Study director, 6october University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117904
- Sponsor's protocol ID
- BeniSuefUU
- Status last verified
- Jul 2024
- First submitted
- 31 Oct 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Delaney G, Jacob S, Featherstone C, Barton M. The role of radiotherapy in cancer treatment: estimating optimal utilization from a review of evidence-based clinical guidelines. Cancer. 2005 Sep 15;104(6):1129-37. doi: 10.1002/cncr.21324.
PubMed 16080176Saadeh CE. Chemotherapy- and radiotherapy-induced oral mucositis: review of preventive strategies and treatment. Pharmacotherapy. 2005 Apr;25(4):540-54. doi: 10.1592/phco.25.4.540.61035.
PubMed 15977916
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects and Safety of MEBO as Add on Therapy for the Prevention of Radiotherapy-Induced Mucositis
- ClinicalTrials.gov ID
- NCT06117904
- Acronym / sponsor ID
- BeniSuefUU
- Conditions
- Radiotherapy Side Effect, Mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Sohag University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 7 Nov 2023 (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.
Radiation therapy (RT) is used in at least 50% of cancer patients and is critical in treating and palliating tumor-related symptoms. Normal tissue radiation toxicity remains an overwhelming obstacle in treating cancer patients with localized tumors.
Mucositis is the inflammation and ulceration of the oral and gastrointestinal mucosa observed with different cancer therapies. Oral mucositis is a common, severe, and debilitating complication of RT occurring several days to weeks after RT initiation.
Detailed description
This study is a single blind randomized controlled clinical trial with a parallel-group design conducted in the clinical oncology department of Beni-Suef University Hospital.
A total of 50 patients with head and neck cancer receiving RT were randomly assigned into either study group:
Group 1 (Intervention group):
This group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks
Group 2 (Control group):
This group included twenty-five patients given symptomatic therapy 3 times daily for 7 weeks.
These therapies included anti-fungal agents (Miconaz oral gel), topical anesthetics and anti-inflammatory drugs (BBC oral spray), topical analgesic gel (Oracure gel), sodium bicarbonate mouthwash (Alkamisr sachets)
- Oral mucositis severity was measured by the World Health Organization Toxicity Scale (WHO grading system). Based on the symptomatic (oral pain), and functional clinical features of every patient (ability to drink and eat) as well as the presence of lesions (ulcers, erythema), the measurements were categorized to Grade I: presence of soreness and erythema, Grade II: presence of painful erythema and ulcerations that do not affect the patient solid food intake, Grade Ш: confluent ulceration that affect the solid food intake and require liquid diet, and Grade ΙV: the patient requires parenteral nutrition.
- Discomfort and pain severity were recorded using the Numeric Rating Scale (NRS), which is categorized to no pain (NRS 0), mild pain (NRS 1-3), moderate pain (NRS 4-7), and unbearable pain (NRS 8-10). Patients were asked to assign a numerical score on the scale verbally to rate their pain intensity, and the number was recorded
- Dry mouth, Dysphagia was measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care.
Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEBO ointment + symptomatic therapy | Experimental | Drug: MEBO ointment, Drug: Symptomatic treatment onlyThis group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks. |
| symptomatic therapy | Active comparator | Drug: Symptomatic treatment onlyThis group included twenty-five patients given symptomatic therapy 3 times daily for 7 weeks. These therapies included anti-fungal agents (Miconaz oral gel), topical anesthetics and anti-inflammatory drugs (BBC oral spray), topical analgesic gel (Oracure gel), sodium bicarbonate mouthwash (Alkamisr sachets). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (>18 years) with histopathologically confirmed Head and Neck Cancer (HNC), primary tumor in the stages T1, T2, T3, or T4, a regional node of any N status, and distant metastases absent.
- All patients who were going to receive RT (dose between 60-70 Gy) on the head and neck region as postoperative (adjuvant) or definitive therapy. Either these patients had received chemotherapy prior or in concomitant to radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 to 2 and normal hematologic and biochemical parameters.
Key exclusion criteria (5 listed)
- patients undergoing previous radiotherapy
- uncontrolled systemic or widely disseminated disease
- having any physical or mental abnormality,
- pregnant and lactating women
- presence of a synchronous double primary malignancy or simultaneous participation in another clinical trial
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 |
|---|---|---|
| MEBO ointmentThis group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks | Drug | MEBO ointment + symptomatic therapy |
| Symptomatic treatment onlyThis group included twenty-five patients given symptomatic therapy 3 times daily for 7 weeks. These therapies included anti-fungal agents (Miconaz oral gel), topical anesthetics and anti-inflammatory drugs (BBC oral spray), topical analgesic gel (Oracure gel), sodium bicarbonate mouthwash (Alkamisr sachets). | Drug | MEBO ointment + symptomatic therapy, symptomatic therapy |
Primary outcome
Oral mucositis Severity
Time frame: 7 weeks
Oral mucositis severity was measured by the World Health Organization Toxicity Scale (WHO grading system) Grade 1 Mild; asymptomatic Grade 2 Moderate; minimal, local inflammation Grade 3 Severe or medically significant Grade 4 Life-threatening Grade 5 Death
2 secondary outcomes
Dry mouth, Dysphagia score
Time frame: 7 weeks
Discomfort and pain severity
Time frame: 7 weeks
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 25 Jul 2024.
- Background: PubMed 16080176Delaney G, Jacob S, Featherstone C, Barton M. The role of radiotherapy in cancer treatment: estimating optimal utilization from a review of evidence-based clinical guidelines. Cancer. 2005 Sep 15;104(6):1129-37. doi: 10.1002/cncr.21324.
- Background: PubMed 15977916Saadeh CE. Chemotherapy- and radiotherapy-induced oral mucositis: review of preventive strategies and treatment. Pharmacotherapy. 2005 Apr;25(4):540-54. doi: 10.1592/phco.25.4.540.61035.
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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.
Engy Wahsh study director
6october University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEBO ointment and Symptomatic treatment only in people with Radiotherapy Side Effect and Mucositis, run by Beni-Suef University at 1 site in Egypt.
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 3 inclusion and 5 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 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Oral mucositis Severity (time frame: 7 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 NCT06117904, which also lists 2 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 25 Jul 2024.