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)
PRIMARY OBJECTIVES:
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).
SECONDARY OBJECTIVES:
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
Questionnaire [OMDQ]).
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.
Interventional
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
No
Anurag Singh
Principal Investigator
Roswell Park Cancer Institute
United States: Food and Drug Administration
I 184910
NCT01674374
May 2013
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