Serum-derived Bovine Immunoglobulin Effect on Mucositis

• ClinicalTrials.gov Identifier: NCT04239261
• Recruitment Status: Terminated
• First Posted: January 27, 2020
• Last Update Posted: January 26, 2023
• Sponsor: MercyOne Des Moines Medical Center
• Information provided by (Responsible Party): Richard Deming, MD, MercyOne Des Moines Medical Center

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
Mucositis	Dietary Supplement: SBI; Dietary Supplement: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: 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
• Actual Study Start Date: January 17, 2020
• Actual Primary Completion Date: January 24, 2023
• Actual Study Completion Date: January 24, 2023

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 :

1. Development of Oral Mucositis during ChemoRadiation Treatment [ Time Frame: 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 :

1. Development of Dysphagia during ChemoRadiation Treatment [ Time Frame: Baseline and Up to approximately 90 days after randomization ]
   CTCAE version 5 will be used to determine advent grade of dysphagia, if applicable
2. Change in Bowel Movements [ Time Frame: 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

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

Criteria

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.

Contacts and Locations

Locations

United States, Iowa

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

More Information

• Responsible Party: Richard Deming, MD, Principal Investigator, MercyOne Des Moines Medical Center
• ClinicalTrials.gov Identifier: NCT04239261
• Other Study ID Numbers: HNL-MUCO
• First Posted: January 27, 2020
• Last Update Posted: January 26, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Mucositis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases