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Trial record 42 of 48 for:    gum disease | NIH

Prevention of Oral Mucositis After Using Oral Topical Vitamin E Versus Voriconazole and Levofloxacin in Pediatric Cancer Patients Receiving Chemotherapy

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ClinicalTrials.gov Identifier: NCT03613389
Recruitment Status : Enrolling by invitation
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Samah omer Mekki, Cairo University

Brief Summary:

Statement of problem Oral mucositis is an inflammatory condition that affects mucosa of the oral cavity. The etiology of this kind of aggravation is related to the introduction of radiotherapy or chemotherapeutic medications. (Alvarino et al., 2014, Rohani et al., 2015) With the prevalence of mucositis up to 80% in pediatric patient (Cheng et al., 2004).

Clinically, oral mucositis is a painful situation that significantly affects patients' quality of life. The severe cases are associated with ulcerated mucosa and secondary infection which may led to life-threatening sepsis. (Kolokythas , et al., 2010) Oral mucositis is one of the most debilitating complications following chemotherapy, its remains an unresolved clinical problem, and it has physical and psychosocial implications for patients. The ulcerative lesions are often very painful, requiring treatment with analgesics and supportive nutrition, and the cancer treatment may need to be interrupted or modified. All these conditions may increase treatment costs, preclude further treatment and alter the quality of life of the patient. (Sonis et al., 2001) There are many oral care regimens including prophylactic antibacterial and antifungal drugs, Levofloxacin is antibacterial drug causing inhibition of cell wall synthesis agent, Levofloxacin failed to show any significant difference in mucositis or oral ulceration (Bucaneve et al., 2005). While voriconazole is antifungal that has been noted to cause transient visual disturbances and A major drawback is potential interactions with certain chemotherapy agents (Marks et al., 2011).

Vitamin E is an antioxidant agent which may limit tissue damage from free oxygen radicals and, thus, may reduce the severity of mucositis during cancer treatments and protect cell membranes from radiation damage (Alterio et al., 2007). It has a very low toxicity and is generally well-tolerated (Geeraert et al., 2015).

Rationale

There is no enough studies about vitamin E effect in reduction of oral mucositis.

El -Housseiny et al., (2007), recommend that oral mucositis is successfully treated by the topical application of vitamin "E", compared to its systemic administration. Vitamin "E" alone is not enough for the treatment of infected lesions; further studies using vitamin "E" to treat the infected lesions are needed.

Also based on the recommendation of Wadleigh et al., (1992) who was the first one to study the topical effect of vitamin "E" on oral mucositis; however, they did not know whether the effect was due to the topical application or the systemic absorption of the vitamin when applied topically.

Benefit to patient and population:

The vitamin E is nontoxic, odorless, tasteless, and well tolerated by the patients, reduce nutritional compromise, maintain impact on quality of life, and reasonable economic costs.

Benefits of practitioners and clinicians:

The use of vitamin E is easy to apply, not technique sensitive and it is cheap and readily available reducing clinical time.


Condition or disease Intervention/treatment Phase
Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy Dietary Supplement: oral topical vitamin E Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Oral Mucositis After Using Oral Topical Vitamin E Versus Voriconazole and Levofloxacin in Pediatric Cancer Patients Receiving Chemotherapy
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : September 1, 2019


Arm Intervention/treatment
Experimental: oral topical vitamin E Dietary Supplement: oral topical vitamin E
Vitamin E is an antioxidant agent which may limit tissue damage from free oxygen radicals and, thus, may reduce the severity of mucositis during cancer treatments and protect cell membranes from radiation damage (Alterio et al., 2007). It has a very low toxicity and is generally well-tolerated (Geeraert et al., 2015).

No Intervention: voriconazole and levofloxacin



Primary Outcome Measures :
  1. Clinical assessment of Oral Mucositis [ Time Frame: 5 days ]

    Oral mucositis WHO Toxicity Scale (Paula Elaine et al., 2016)will be ranked according to WHO classification criteria (Appendix B):

    • Grade 0: No change.
    • Grade 1: Soreness/erythema. • Grade 2: Erythema, and Ulcers; patient can eat solids. • Grade 3: Ulcers; the patient requires liquid diet only. • Grade 4: Oral nourishment is not possible.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All children fulfilling the following criteria will be included:

    1. Patients with healthy and intact oral mucosa.
    2. Patients diagnosed with Acute Myeloid leukemias for the first time or during consolidation cycle.
    3. Both male and female patients undergoing chemotherapy at in and Out patient units of Pediatric Oncology department.
    4. Age of patient ranging (6- 18) years old.
    5. Legal representatives of patient must be able to read, understand and provide informed consent to participate in the trial.
    6. Patients with no history of dental discomfort related to cold or hot food or beverage intake.
    7. Patients receiving chemotherapeutic regimen known to cause oral mucositis (e.g. Cytarabine and Etoposide).

Exclusion Criteria:

  • Exclusion criteria included the presence of any of the following:

    1. Administration of antiviral or antifungal therapy and/or any other treatment for oral mucositis before enrollment in the study.
    2. Presence of advanced or severe periodontitis (pocket depth more than 6mm).
    3. Patients who are scheduled for radiotherapy as part of their treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613389


Locations
Egypt
Samah Omer Mekki
Cairo, Egypt, 0020
Sponsors and Collaborators
Cairo University
National Cancer Institute (NCI)

Responsible Party: Samah omer Mekki, B.D.S, Faculty of Dentistry, Khartoum College of Medical Sciences, Sudan (2011), Cairo University
ClinicalTrials.gov Identifier: NCT03613389     History of Changes
Other Study ID Numbers: CEBD-CU-2018-06-20
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases
Periodontal Diseases
Mucositis
Stomatitis
Gingivitis, Necrotizing Ulcerative
Gastroenteritis
Fusobacterium Infections
Fusobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Gingivitis
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Levofloxacin
Ofloxacin
Voriconazole
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents