Mucositis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTSBI
Serum-derived Bovine immunoglobulin/protein isolate 10.0 g once daily
DIETARY_SUPPLEMENTPlacebo
Hydrolyzed gelatin 10.0 g once daily
Sponsors
MercyOne Des Moines Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of Oral Mucositis during ChemoRadiation Treatment | Baseline and Up to approximately 90 days after randomization | CTCAE version 5 will be used to determine adverse event grade of mucositis, if applicable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of Dysphagia during ChemoRadiation Treatment | Baseline and Up to approximately 90 days after randomization | CTCAE version 5 will be used to determine advent grade of dysphagia, if applicable |
| Change in Bowel Movements | Baseline and Up to approximately 90 days after randomization | Stool Diary Card will be completed by patient to document consistency, ease and completeness |
Countries
United States
Outcome results
None listed