Protective Effect Of Vitamin E (VE ) In Head And Neck Cancer Radiation Induced Mucositis: A Double-Blind Randomized Trial

Reviewer: Roberto Santiago, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: May 22, 2002

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Presenter: Paulo R Ferreira
Presenter's Affiliation: Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil
Type of Session: Scientific

Background

  • Vitamin E is the most important antioxidant in the human body
  • It scavenges free radicals and prevents lipid membrane peroxidation
  • Vitamin E has been proposed as a potential radioprotectant agent
  • A few small studies have suggested that vitamin E can significantly reduce the incidence of oral mucositis observed during the treatment of cancer patients (Osaki et al, Lopez et al, and Wadleigh et al)
  • Patients with cancer of the head and neck treated with radiotherapy are at especially high risk for developing oral mucositis
  • The resulting pain and dysphagia can be severe, leading to malnutrition, infection, medical interventions, and reliance on narcotic analgesics
  • Oxygen free radicals and their effects on microvasculature has been postulated to play a role in the pathogenesis of radiotherapy-related oral mucositis
  • No effective prevention for mucositis exists to date

Materials and Methods

  • A prospective double-blind randomized trial was design to evaluate the protective effectiveness of vitamin E against oral mucositis in patients with squamous cell carcinomas of the oral cavity and oropharynx treated with radiation therapy alone
  • Patient and tumor characteristics, including alcohol intake and smoking, were well balanced among the treatment arm
  • Only Pre- or postoperative radiotherapy conventionally fractionated was used
  • Experimental treatments consisted of twice-daily 5-minute oral cavity rinse (and swallow) just before radiotherapy and 12 hours later every day using either vitamin E (400 mg oil solution) or placebo (500 mg capsules of primrose oil)
  • Radiation doses ranged from 50?70 Gy delivered in 2 Gy fractions 5 days a week using parallel opposed fields with Cobalt units (minimum area of 12.2 square centimeters)
  • The patient?s oral cavities in both arms were clinically inspected once a week and mucositis was evaluated the 4-tier RTOG toxicity scale
  • Patients were given a simple non-validated questionnaire to assess quality of life similar to that used in comparable studies
  • Mucosal cells were collected weekly for micronuclei assay (cellular surrogate for radiation damage)
  • The density of incidence of severe mucositis was evaluated in both arms (# of mucositis events > grade 2 ¸ # ?patient-weeks? of exposure)
  • The duration of mucositis and the patient?s weights were also assessed

Results

  • Patients in the placebo group had severe mucositis more frequently than those in the vitamin E group (54 events / 161 patients-week = 33.5% versus 36 events / 167 patients-week = 21.6%, p=0.038)
  • Vitamin E afforded a 36% reduction in the risk of severe mucositis
  • Pain was worst in the placebo group
  • There was no significant difference in the duration of mucositis or on weight loss experienced by the patients in the two arms
  • No adverse effects were attributable to the experimental treatment in either arm

Author's Conclusions

  • Vitamin E is very well tolerated in patients undergoing radiotherapy for cancer of the head and neck
  • Vitamin E afforded a reduction in the incidence of severe radiation-induced mucositis in patients treated for cancer of the head and neck

Clinical/Scientific Implications

  • The study was limited by the collection of one assessment per week in a small number of patients
  • The density of incidence method conceals this limitation
  • They used a quality of life tool that was not validated
  • The survival in the treatment arms did not differ significantly
  • The findings of this study should prompt larger carefully designed trials to further investigate the potential benefit afforded by vitamin E
  • Long-term follow-up will be needed to assess local control and survival as there is a theoretical tumor protection possibility with vitamin E utilization

Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.


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