Bovine Lactoferrin in Reducing Taste Disturbances in Patients With Colorectal Cancer Receiving Oxaliplatin-Based Chemotherapy
|ClinicalTrials.gov Identifier: NCT01596634|
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Dysgeusia Oral Complications of Chemotherapy||Other: questionnaire administration Procedure: quality-of-life assessment Other: laboratory biomarker analysis Dietary Supplement: bovine lactoferrin||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||October 10, 2015|
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 studiesDietary Supplement: bovine lactoferrin
- 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.).
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|