Trials / Terminated
TerminatedNCT04239261
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- MercyOne Des Moines Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | SBI | Serum-derived Bovine immunoglobulin/protein isolate 10.0 g once daily |
| DIETARY_SUPPLEMENT | Placebo | Hydrolyzed gelatin 10.0 g once daily |
Timeline
- Start date
- 2020-01-17
- Primary completion
- 2023-01-24
- Completion
- 2023-01-24
- First posted
- 2020-01-27
- Last updated
- 2023-01-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04239261. Inclusion in this directory is not an endorsement.