Serum-derived Bovine Immunoglobulin Effect on Mucositis

NCT04239261 | Terminated Phase 2 FDA Drug

• 1 other identifier: HNL-MUCO
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucositis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Development of Dysphagia during ChemoRadiation Treatment

  Baseline and Up to approximately 90 days after randomization

• Change in Bowel Movements

  Baseline and Up to approximately 90 days after randomization

Study Arms (2)

Nutritional therapy

ACTIVE COMPARATOR

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

Dietary Supplement: SBI

Placebo

PLACEBO COMPARATOR

Hydrolyzed gelatin 10.0 grams once daily

Dietary Supplement: Placebo

Interventions

SBI DIETARY_SUPPLEMENT

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

Nutritional therapy

Placebo DIETARY_SUPPLEMENT

Hydrolyzed gelatin 10.0 g once daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• MercyOne Des Moines Medical Center: lead

Study Sites (1)

MercyOne Des Moines Medical Center

Des Moines, Iowa, 50314, United States

Location

MeSH Terms

Conditions

Mucositis

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard Deming, MD

  MercyOne Des Moines Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 27, 2020
• Study Start: January 17, 2020
• Primary Completion: January 24, 2023
• Study Completion: January 24, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)