Bovine Lactoferrin in Reducing Taste Disturbances in Patients With Colorectal Cancer Receiving Oxaliplatin-Based Chemotherapy
Oral Complications of Chemotherapy
Other: questionnaire administration
Procedure: quality-of-life assessment
Other: laboratory biomarker analysis
Biological: bovine lactoferrin
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Pilot Study of Bovine Lactoferrin in Patients With Colorectal Carcinoma Receiving Oxaliplatin-Based Chemotherapy and Self-Reported Taste Disturbances|
- Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses [ Time Frame: Approximately 1 month ] [ Designated as safety issue: No ]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.).
- Effect of bovine lactoferrin on lipid peroxidation byproducts in saliva as measured by the TBARs assay [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]
- Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]
- Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) questionnaire [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
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: questionnaire administration
Ancillary studiesProcedure: quality-of-life assessment
Other Name: quality of life assessmentOther: laboratory biomarker analysis
Correlative studiesBiological: bovine lactoferrin
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
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596634
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Glenn Lesser||Wake Forest University Health Sciences|