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Serum-derived Bovine Immunoglobulin Effect on Mucositis

NCT04239261 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-01-26

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

SBI

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

DIETARY_SUPPLEMENT

Placebo

Hydrolyzed gelatin 10.0 g once daily

Sponsors & Collaborators

  • MercyOne Des Moines Medical Center

    lead OTHER

Principal Investigators

  • Richard Deming, MD · MercyOne Des Moines Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-17
Primary Completion
2023-01-24
Completion
2023-01-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04239261 on ClinicalTrials.gov