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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Dysgeusia; Oral Complications of Chemotherapy
• Intervention / Treatment: Other: laboratory biomarker analysis; Other: questionnaire administration; Procedure: quality-of-life assessment; Dietary supplement: bovine lactoferrin

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Supportive care (bovine lactoferrin); Patients receive bovine lactoferrin PO (rinse or tablet) TID for 1 month. Treatment continues in the absence of unacceptable toxicity.	Other: laboratory biomarker analysis; Correlative studies; Other: questionnaire administration; Ancillary studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Dietary supplement: bovine lactoferrin; Given PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2013
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): October 10, 2015

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 10, 2012
• First Posted (ESTIMATE): May 11, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Sensation Disorders; Taste Disorders; Colorectal Neoplasms; Dysgeusia; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: IRB00020136; NCI-2012-00279 (REGISTRY: CTRP (Clinical Trial Reporting Program)); CCCWFU 98112 (OTHER: Wake Forest University Health Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No