Serum-derived Bovine Immunoglobulin Effect on Mucositis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Nutritional therapy Serum-derived bovine immunoglobulin/protein isolate (SBI) 10.0 grams once daily |
Dietary Supplement: SBI
Serum-derived Bovine immunoglobulin/protein isolate 10.0 g once daily
|
Placebo Comparator: Placebo Hydrolyzed gelatin 10.0 grams once daily |
Dietary Supplement: Placebo
Hydrolyzed gelatin 10.0 g once daily
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed consent obtained and signed
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Male or female at least 18 years of age
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Diagnosed with head, neck, or lung cancer and scheduled to undergo combined chemo-radiation therapy
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Diagnosed with head, neck, or lung cancer with disease stage within the criteria described in 4.0 Staging Criteria
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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.
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Not currently taking anti-diarrheal medications (prescription or over the counter).
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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:
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History of uncontrolled diarrhea during screening.
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History of Irritable Bowel Syndrome with Diarrhea with a normal pattern of more than three bowel movements in a 24 hour period.
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History of inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis.
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History of active infectious diarrhea and receiving therapy within 10 days of the first dose of study drug or placebo.
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Known allergy or intolerance to beef or soy or any ingredient used in the product
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History of concurrent intensive chemotherapy within 10 days of the first scheduled dose of study drug or placebo.
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Gastrointestinal surgery or bowel resection that could affect study product absorption (this does not include cholecystectomy or appendectomy).
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Unable to comply with the protocol requirements.
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Any condition that in the opinion of the Investigator might interfere with the study objective.
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Women who are pregnant or breastfeeding.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | MercyOne Des Moines Medical Center | Des Moines | Iowa | United States | 50314 |
Sponsors and Collaborators
- MercyOne Des Moines Medical Center
Investigators
- Principal Investigator: Richard Deming, MD, MercyOne Des Moines Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HNL-MUCO