The purpose of this cancer control clinical research study is to evaluate whether nutritional therapy with Serum-derived bovine immunoglobulin/protein isolate (SBI) might reduce mucositis (a condition caused by cancer treatment involving mouth sores, pain and/or bleeding that may cause difficulty eating), improve nutritional status and lessen the symptoms associated with chemo-radiation therapy which may result in quality of life (QOL) improvements during the prescribed treatment for cancer therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
10
MercyOne Des Moines Medical Center
Des Moines, Iowa, United States
Development of Oral Mucositis during ChemoRadiation Treatment
CTCAE version 5 will be used to determine adverse event grade of mucositis, if applicable
Time frame: Baseline and Up to approximately 90 days after randomization
Development of Dysphagia during ChemoRadiation Treatment
CTCAE version 5 will be used to determine advent grade of dysphagia, if applicable
Time frame: Baseline and Up to approximately 90 days after randomization
Change in Bowel Movements
Stool Diary Card will be completed by patient to document consistency, ease and completeness
Time frame: Baseline and Up to approximately 90 days after randomization
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