Topical Oral Vitamin D Gel Ameliorates Radiation-Induced Oral Mucositis

 

TAKE-HOME MESSAGE

  • In this randomized controlled trial designed to evaluate the effectiveness of topical oral vitamin D gel in the prevention of radiation-induced oral mucositis (RIOM), participants in group 1 received conventional treatment, those in group 2 received topical oral vitamin D gel, and those in group 3 received both oral vitamin D gel and conventional treatment. After 6 weeks of radiation therapy (RT), 33.3% of patients in group 1 manifested high-grade severity on the WHO oral mucositis scale, while patients in groups 2 and 3 had low-grade severity or complete remission. After 6 weeks of RT, there was a statistically significant difference in pain scores between group 1 and groups 2 and 3 (P < .05), but no significant difference in pain scores between groups 2 and 3.

  • RIOM is the most serious non-hematological complication of radiation therapy. The authors conclude that topical oral vitamin D gel dampened oral mucositis development and reduced pain sensation during RT for head and neck cancer.
–  Laurie C. Carter, DDS, PhD  Clinical Dentistry

In this study by Bakr and colleagues, a novel approach to reduce the severity of oral mucositis and its symptoms during radiation therapy is tested. The patients who were treated for head and neck cancer received prophylactically either the standard of care (mostly a mixture of antifungals, anti-inflammatory agents, and analgesics), topical applications of vitamin D gel, or a combination of both. A total of 15 patients were randomized into each treatment group in this non-blinded study. Oral mucositis scores (WHO scale) and symptoms (pain/discomfort on a numeric scale) were measured and compared 3 weeks and 6 weeks after the initiation of radiation therapy.

Vitamin D gel applications, alone or in combination with the standard of care, significantly improved WHO scores at the 6-week time point as well as the pain/discomfort intensity at both the 3-week and 6-week time points (when compared with standard of care alone). The authors were able to demonstrate an increased serum level of vitamin D in those receiving the gel applications in support of the effectiveness of this route of administration.

The authors recognize that, although promising, the proposed approach needs to be further investigated. The lack of blinding of both subjects and examiners, the small sample size, the single-center nature of the study, and the lack of a correlative study between the increase in vitamin D serum levels and the response to treatment necessitate further studies. Nonetheless, this innovative and clinically meaningful report may eventually help in the design of a better management approach to a significant and frequently observed morbidity of cancer treatment for which little can be offered. The long-term effects of vitamin D supplementation on the recovery and health of head and neck cancer patients receiving radiation therapy and whether vitamin D is best administered topically or systemically will have to be determined in multicenter studies.

OBJECTIVES

The aim of this clinical trial is to evaluate the effectiveness of topical oral vitamin D gel in prevention of radiation-induced oral mucositis.

MATERIAL AND METHODS

A three-armed randomized controlled clinical trial on forty-five head and neck cancer patients was conducted. First group: conventional treatment. Second group: Topical oral vitamin D gel. Third group: topical oral vitamin D gel plus the conventional treatment. All the patients were examined clinically three and six weeks after the start of radiotherapy for pain and WHO mucositis score.

RESULTS

After 6 weeks of radiotherapy, (33.5%) the patients in control group developed high-grade severity of oral mucositis while the patients in the two-test groups "vitamin D group and combined therapy group" remained with low-grade severity or with complete remission. Mean pain scores showed a significant decrease in the combined therapy group and to a close degree in vitamin D group rather than the control group.

CONCLUSION

Topical oral vitamin D gel has a beneficial effect in lowering oral mucositis development and in reducing pain sensation during the radiation period especially when combined with conventional therapeutic agents.

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