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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596634
• Other study ID #: IRB00020136
• Secondary ID: NCI-2012-00279CC
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: October 10, 2015

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 10, 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed colorectal carcinoma

• There are no restrictions on the amount or types of prior therapy

• Eligible patients must be receiving ongoing chemotherapy with an oxaliplatin containing-regimen which is planned to continue for at least one month following enrollment in this trial

• Any dose or schedule of oxaliplatin administration is allowed as long as patients have self-reported taste disturbance that has either:

• 1) developed since the initiation of oxaliplatin-based therapy, or

• 2) a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating oxaliplatin-based therapy

• Patients must have normal baseline self-reported taste perception prior to the development of colorectal carcinoma

• Life expectancy of >= 3 months

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Patients with a subjective history of an extreme dry mouth syndrome that prevents them from producing adequate amounts of saliva (approximately 2 mL in 15-20 min)

• Patients known to be human immunodeficiency virus (HIV)-positive

• Patients with any of the following conditions: untreated gastrointestinal reflux disease; untreated diabetes mellitus; active thrush; active oral infection; active mucositis

• Patients who are known to be pregnant or who are breastfeeding are excluded

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Dysgeusia
• Oral Complications of Chemotherapy

Intervention

Other:
• questionnaire administration
Ancillary studies

Procedure:
• quality-of-life assessment
Ancillary studies

Other:
• laboratory biomarker analysis
Correlative studies

Dietary Supplement:
• bovine lactoferrin
Given PO

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses	Paired-tests will be used to assess the significance of these changes. Linear regression models will be used to determine which patient covariates are associated with change. Repeated measures models will also be used to assess the changes over time using all the repeated measures and contrasts will be used to assess individual pair-wise differences. Descriptive reports will consist of summary statistics (means, standard deviations, proportions, etc.).	Approximately 1 month
Secondary	Effect of bovine lactoferrin on lipid peroxidation byproducts in saliva as measured by the TBARs assay		Approximately 2 months
Secondary	Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse		Approximately 2 months
Secondary	Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) questionnaire		Approximately 2 months