A Pilot Study of Bovine Lactoferrin in Patients With Colorectal Carcinoma Receiving Oxaliplatin-Based Chemotherapy and Self-Reported Taste Disturbances
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
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
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Comprehensive Cancer Center of Wake Forest University||Winston-Salem, North Carolina 27157-1082|