Serum-derived Bovine Immunoglobulin Effect on Mucositis

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Randomized, Placebo-Controlled, Pilot Study of Serum-Derived Bovine Immunoglobulin/Protein Isolate to Manage Mucositis in Patients Undergoing Treatment for Head, Neck, or Lung Cancer

Conditions
-----------------
Mucositis

Intervention / Treatment
-----------------
* Dietary Supplement: SBI
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained and signed Male or female at least 18 years of age Diagnosed with head, neck, or lung cancer and scheduled to undergo combined chemo-radiation therapy Diagnosed with head, neck, or lung cancer with disease stage within the criteria described in 4.0 Staging Criteria Not experiencing diarrhea during the 5 days preceding enrollment, as defined by having less than two unformed bowel movements per day or loose (mushy) or watery stools in the 5 days preceding enrollment. Not currently taking anti-diarrheal medications (prescription or over the counter). Agrees and is able to take the investigational products or placebo starting from the day of enrollment (approximately 7-14 days prior to beginning chemo-radiation therapy) through 6-7 weeks of chemo-radiation therapy (for a total of 8-9 weeks). Exclusion Criteria: History of uncontrolled diarrhea during screening. History of Irritable Bowel Syndrome with Diarrhea with a normal pattern of more than three bowel movements in a 24 hour period. History of inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis. History of active infectious diarrhea and receiving therapy within 10 days of the first dose of study drug or placebo. Known allergy or intolerance to beef or soy or any ingredient used in the product History of concurrent intensive chemotherapy within 10 days of the first scheduled dose of study drug or placebo. Gastrointestinal surgery or bowel resection that could affect study product absorption (this does not include cholecystectomy or appendectomy). Unable to comply with the protocol requirements. Any condition that in the opinion of the Investigator might interfere with the study objective. Women who are pregnant or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutritional therapy<br>Serum-derived bovine immunoglobulin/protein isolate (SBI) 10.0 grams once daily | Dietary Supplement: SBI<br>* Serum-derived Bovine immunoglobulin/protein isolate 10.0 g once daily<br>|
| Placebo Comparator: Placebo<br>Hydrolyzed gelatin 10.0 grams once daily | Dietary Supplement: Placebo<br>* Hydrolyzed gelatin 10.0 g once daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Oral Mucositis during ChemoRadiation Treatment | CTCAE version 5 will be used to determine adverse event grade of mucositis, if applicable | Baseline and Up to approximately 90 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Dysphagia during ChemoRadiation Treatment | CTCAE version 5 will be used to determine advent grade of dysphagia, if applicable | 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 | Baseline and Up to approximately 90 days after randomization |