The purpose of this study is to find out what effects (good and bad) SAMITAL (Vaccinium myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules) has on the management of mucositis (inflammation and ulceration that occurs in the mouth) brought on by chemotherapy and radiation therapy for squamous cell carcinoma of the head and neck
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
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.
Time frame: Up to 3 months after completion of study treatment
Severity and duration of mucositis as assessed by dichotomized WHO Mucositis Global Severity Score (0-2 vs 3-4) and/or OMDQ scores
The 2 treatment groups will be compared. The Mantel-Haenszel test, stratified by disease site and type of therapy, will be used for these comparisons.
Time frame: Up to 3 months after completion of study treatment
Quality of life as assessed by EORTC QLQ-C30 questionnaire (with 1 being not at all and 4 being very much)
The 2 treatment groups will be compared. Will be analyzed using Mann-Whitney U tests. All secondary analyses will be carried out using two-sided tests at the 10% level of significance.
Time frame: Up to 3 months after completion of study treatment
Quality of Life as assessed by EORTC QLQ Head and Neck Cancer-Specific Module function and symptom sub-scores between groups (with 1 being not at all and 4 being very much)
The 2 treatment groups will be compared. Will be analyzed using Mann-Whitney U tests. All secondary analyses will be carried out using two-sided tests at the 10% level of significance.
Time frame: Up to 3 months after completion of study treatment
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