Serum-derived Bovine Immunoglobulin Effect on Mucositis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Mucositis

In brief

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.

Key facts

Study ID

NCT04239261

Run by

MercyOne Des Moines Medical Center

People needed

10

Starts

2020-01-17

Expected to finish

2023-01-24

Last updated by the study team

2023-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• MercyOne Des Moines Medical Center — Des Moines, Iowa, United States

Full record on ClinicalTrials.gov

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