A Phase 2 Placebo Controlled Randomized Study of the Effect of SAMITAL on Severity and Duration of Mucositis Induced by Chemoradiation for Head and Neck Cancer (HNC)
I. To assess the tolerability of SAMITAL granules for suspension. II. To assess the efficacy
of SAMITAL granules for suspension in reducing the incidence of severe mucositis (World
Health Organization [WHO] mucositis scale score of 3 or 4) induced by concurrent
chemoradiation for head and neck cancer (HNC).
I. To assess the effect of SAMITAL granules for suspension on the severity and duration of
mucositis (WHO mucositis scale and patient self-assessment with the Oral Mucositis Daily
II. To assess the effect of SAMITAL granules for suspension on validated patient reported
quality of life measures (European Organization for Research and Treatment of Cancer [EORTC]
Quality of Life Questionnaire [QLQ]-C30 and EORTC QLQ Head and Neck Cancer Specific Module).
III. To assess the rate of any grade 3 - grade 4 infections. IV. To assess the cumulative
dose of opioids needed. V. To assess weight loss and need for tube feeding. VI. To assess
treatment breaks and/or chemotherapy dose reduction.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Beginning as soon as symptoms arise during chemoradiotherapy, patients receive
Vaccinium myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract
granules orally (PO) four times daily (QID). Patients may continue to receive Vaccinium
myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules for up
to 4 weeks after completion of radiation therapy for a maximum of 11 weeks.
ARM II: Beginning as soon as symptoms arise during chemoradiotherapy, patients receive
placebo PO QID. Patients may continue to receive placebo for up to 4 weeks after completion
of radiation therapy for a maximum of 11 weeks.
After completion of study treatment, patients are followed up for 3 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care
Proportion of patients with severe mucositis (WHO score 3 or 4)
The 2 treatment groups will be compared using the Mantel-Haenszel test, stratified by disease site and type of therapy, using a two-sided test at the alpha= 0.10 level of significance. Since emphasis is placed on the accurate estimation of treatment effect for use in the planning of a future confirmatory trial, corresponding estimates of effect size will also be computed along with 90% confidence intervals.
Up to 3 months after completion of study treatment
Roswell Park Cancer Institute
United States: Food and Drug Administration