Serum-derived Bovine Immunoglobulin Effect on Mucositis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-17

Study Completion Date

2023-01-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Nutritional therapy

Serum-derived bovine immunoglobulin/protein isolate (SBI) 10.0 grams once daily

Group Type ACTIVE_COMPARATOR

SBI

Intervention Type DIETARY_SUPPLEMENT

Serum-derived Bovine immunoglobulin/protein isolate 10.0 g once daily

Placebo

Hydrolyzed gelatin 10.0 grams once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Hydrolyzed gelatin 10.0 g once daily

Interventions

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SBI

Serum-derived Bovine immunoglobulin/protein isolate 10.0 g once daily

Intervention Type DIETARY_SUPPLEMENT

Placebo

Hydrolyzed gelatin 10.0 g once daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No