NCT03613389

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

Status unknown NA Last updated 31 January 2019

What this trial tests

NA trial testing oral topical vitamin E in Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy in 15 participants. Status unknown.

Timeline

1 January 2020

Primary endpoint
1 June 2020

1 September 2020

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	15
Start date	1 January 2020
Primary completion	1 June 2020
Estimated completion	1 September 2020
Sites	1 location across Egypt

Drugs / interventions tested

• oral topical vitamin E

Conditions studied

• Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy — all drugs for Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy →

Sponsor

Cairo University

Who can join

Adults 6 to 18, any sex, with Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of dietary intervention on human diseases: molecular mechanisms and therapeutic potential.
   Xiao YL, Gong Y, Qi YJ, Shao ZM, et al · · 2024 · cited 120× · PMID 38462638 · DOI 10.1038/s41392-024-01771-x