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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses [ Time Frame: Approximately 1 month ]

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.).


Original Primary Outcome: Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses [ Time Frame: From baseline to 1 month ]

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.).


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

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


Information By: Wake Forest University Health Sciences

Dates:
Date Received: May 9, 2012
Date Started: January 2013
Date Completion:
Last Updated: April 17, 2017
Last Verified: April 2017