Serum-derived Bovine Immunoglobulin Effect on Mucositis

A Randomized, Placebo-Controlled, Pilot Study of Serum-Derived Bovine Immunoglobulin/Protein Isolate to Manage Mucositis in Patients Undergoing Treatment for Head, Neck, or Lung Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Mucositis
• Intervention / Treatment: Dietary supplement: SBI; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • MercyOne Des Moines Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of Oral Mucositis during ChemoRadiation Treatment	CTCAE version 5 will be used to determine adverse event grade of mucositis, if applicable	Baseline and Up to approximately 90 days after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of Dysphagia during ChemoRadiation Treatment	CTCAE version 5 will be used to determine advent grade of dysphagia, if applicable	Baseline and Up to approximately 90 days after randomization
Change in Bowel Movements	Stool Diary Card will be completed by patient to document consistency, ease and completeness	Baseline and Up to approximately 90 days after randomization

Collaborators and Investigators

• Sponsor: MercyOne Des Moines Medical Center
• Investigators: Principal Investigator: Richard Deming, MD, MercyOne Des Moines Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2020
• Primary Completion (Actual): January 24, 2023
• Study Completion (Actual): January 24, 2023

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis
• Other Study ID Numbers: HNL-MUCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes