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Adjunctive Treatments for the Prevention of Radiotherapy-Induced Mucositis

Sponsor
Beni-Suef University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06117904
Collaborator
Sohag University (Other)
60
Enrollment
1
Location
2
Arms
11.9
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: MEBO ointment
  • Drug: Symptomatic treatment only
 N/A

Detailed Description

This study is a randomized controlled clinical trial with an open-label and 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)

  1. 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.

  2. 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

  3. 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

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Assessing the Effects and Safety of MEBO as Add on Therapy for the Prevention of Radiotherapy-Induced Mucositis
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: MEBO ointment + symptomatic therapy

This group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks.

Drug: MEBO ointment
This group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks

Drug: Symptomatic treatment only
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).
Active Comparator: symptomatic therapy

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).

Drug: Symptomatic treatment only
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).

Outcome Measures

Primary Outcome Measures

  1. Oral mucositis Severity [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

Secondary Outcome Measures

  1. Dry mouth, Dysphagia score [7 weeks]

    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

  2. Discomfort and pain severity [7 weeks]

    Discomfort and pain severity were recorded using the Numeric Rating Scale (NRS) Grade 1: Mild pain Grade 2: Moderate pain Grade 3: Severe pain

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. 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.

  2. 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.

  3. Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 to 2 and normal hematologic and biochemical parameters.

Exclusion Criteria:

  1. patients undergoing previous radiotherapy

  2. uncontrolled systemic or widely disseminated disease

  3. having any physical or mental abnormality,

  4. pregnant and lactating women

  5. presence of a synchronous double primary malignancy or simultaneous participation in another clinical trial

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asmaa Abdelfattah Elsayed Banī Suwayf Egypt 82511

Sponsors and Collaborators

  • Beni-Suef University
  • Sohag University

Investigators

  • Study Director: Engy Wahsh, 6october University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Asmaa Abdelfattah Elsayed, Lecturer of clinical pharmacy, Beni-Suef University
ClinicalTrials.gov Identifier:
NCT06117904
Other Study ID Numbers:
  • BeniSuefUU
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 14, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Mucositis

Study Results

No Results Posted as of Nov 14, 2023