Serum-derived Bovine Immunoglobulin Effect on Mucositis

MercyOne Des Moines Medical Center

Status and phase

Terminated

Phase 2

Conditions

Mucositis

Treatments

Dietary Supplement: Placebo

Dietary Supplement: SBI

Study type

Interventional

Funder types

Other

Identifiers

NCT04239261

HNL-MUCO

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.