Serum-derived Bovine Immunoglobulin Effect on Mucositis

This is an interventional supportive care trial for Mucositis Read More

Inclusion Criteria:

1. Informed consent obtained and signed
2. Male or female at least 18 years of age
3. Diagnosed with head, neck, or lung cancer and scheduled to undergo combined chemo-radiation therapy
4. Diagnosed with head, neck, or lung cancer with disease stage within the criteria described in 4.0 Staging Criteria
5. 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.
6. Not currently taking anti-diarrheal medications (prescription or over the counter).
7. 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:

1. History of uncontrolled diarrhea during screening.
2. History of Irritable Bowel Syndrome with Diarrhea with a normal pattern of more than three bowel movements in a 24 hour period.
3. History of inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis.
4. History of active infectious diarrhea and receiving therapy within 10 days of the first dose of study drug or placebo.
5. Known allergy or intolerance to beef or soy or any ingredient used in the product
6. History of concurrent intensive chemotherapy within 10 days of the first scheduled dose of study drug or placebo.
7. Gastrointestinal surgery or bowel resection that could affect study product absorption (this does not include cholecystectomy or appendectomy).
8. Unable to comply with the protocol requirements.
9. Any condition that in the opinion of the Investigator might interfere with the study objective.
10. Women who are pregnant or breastfeeding.