NCT06117904

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

October 31, 2023

Last Update Submit

July 24, 2024

Conditions

Radiotherapy Side EffectMucositis

Outcome Measures

Primary Outcomes (1)

  • 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

    7 weeks

Secondary Outcomes (2)

  • Dry mouth, Dysphagia score

    7 weeks

  • Discomfort and pain severity

    7 weeks

Study Arms (2)

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.

Drug: MEBO ointmentDrug: 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).

Drug: Symptomatic treatment only

Interventions

MEBO ointmentDRUG

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

MEBO ointment + symptomatic therapy
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).

MEBO ointment + symptomatic therapysymptomatic therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asmaa Abdelfattah Elsayed

Banī Suwayf, 82511, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 16080176BACKGROUND

  • Saadeh 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.

    PMID: 15977916BACKGROUND

MeSH Terms

Conditions

Radiation InjuriesMucositis

Condition Hierarchy (Ancestors)

Wounds and InjuriesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Engy Wahsh

    6october University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of clinical pharmacy

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 7, 2023

Study Start

January 1, 2024

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

July 25, 2024

Record last verified: 2024-07

Locations

EG(1)