Overview

This trial is active, not recruiting.

Conditions colorectal cancer, dysgeusia, oral complications of chemotherapy
Treatments questionnaire administration, quality-of-life assessment, laboratory biomarker analysis, bovine lactoferrin
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date January 2013
End date August 2016
Trial size 49 participants
Trial identifier NCT01596634, CCCWFU 98112, NCI-2012-00279

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Patients receive bovine lactoferrin PO (rinse or tablet) TID for 1 month. Treatment continues in the absence of unacceptable toxicity.
questionnaire administration
Ancillary studies
quality-of-life assessment quality of life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
bovine lactoferrin
Given PO

Primary Outcomes

Measure
Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses
time frame: Approximately 1 month

Secondary Outcomes

Measure
Effect of bovine lactoferrin on lipid peroxidation byproducts in saliva as measured by the TBARs assay
time frame: Approximately 2 months
Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse
time frame: Approximately 2 months
Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) questionnaire
time frame: Approximately 2 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Pilot Study of Bovine Lactoferrin in Patients With Colorectal Carcinoma Receiving Oxaliplatin-Based Chemotherapy and Self-Reported Taste Disturbances
Principal investigator Glenn Lesser
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.
Location data was received from the National Cancer Institute and was last updated in August 2016.