NCT01596634

Bovine Lactoferrin in Reducing Taste Disturbances in Patients With Colorectal Cancer Receiving Oxaliplatin-Based Chemotherapy

A Pilot Study of Bovine Lactoferrin in Patients With Colorectal Carcinoma Receiving Oxaliplatin-Based Chemotherapy and Self-Reported Taste Disturbances

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine if using a lactoferrin supplement will improve taste perception. Lactoferrin is a type of protein that is naturally produced in the body and is commonly found in saliva.

Detailed description

PRIMARY OBJECTIVES: I. To assess the impact of lactoferrin (bovine lactoferrin) supplementation on self-reported taste and smell disturbances in patients with colorectal cancer receiving oxaliplatin-based chemotherapy SECONDARY OBJECTIVES: I. To assess the impact of lactoferrin supplementation on the baseline lipid peroxidation byproducts in saliva in these patients as measured by the thiobarbituric acid-reactive substances (TBARs) assay. II. To assess the impact of lactoferrin supplementation on the ability of these patients to generate increased lipid peroxidation byproducts when challenged with a weak iron containing solution. III. To assess the impact of lactoferrin supplementation on self-reported general quality of life and on specific self-reported anorexia/cachexia issues in patients with established chemotherapy-induced taste disturbances. IV. To assess the incidence of vitamin D deficiency in patients with oxaliplatin-based therapy induced taste changes OUTLINE: Patients receive bovine lactoferrin orally (PO) (rinse or tablet) thrice daily (TID) for 1 month. Treatment continues in the absence of unacceptable toxicity. After completion of study treatment, patients are followed up at 2 and 4 weeks.

Conditions

• Colorectal Cancer
• Dysgeusia
• Oral Complications of Chemotherapy

Interventions

Type	Name	Description
OTHER	questionnaire administration	Ancillary studies
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	laboratory biomarker analysis	Correlative studies
DIETARY_SUPPLEMENT	bovine lactoferrin	Given PO

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-08-01
• Completion: 2015-10-10
• First posted: 2012-05-11
• Last updated: 2018-07-03

Locations

1 site across 1 country: United States