Colorectal Cancer | Bovine Lactoferrin in Reducing Taste Disturbances in Patients With Colorectal Cancer Receiving Oxaliplatin-Based Chemotherapy
Colorectal Cancer research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Oral Complications of Chemotherapy
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:questionnaire administrationAncillary studies
Procedure:quality-of-life assessmentAncillary studies
Other:laboratory biomarker analysisCorrelative studies
Dietary Supplement:bovine lactoferrinGiven PO
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Supportive care (bovine lactoferrin)Patients receive bovine lactoferrin PO (rinse or tablet) TID for 1 month. Treatment continues in the absence of unacceptable toxicity.
Start Date: January 2013
Completed Date: October 10, 2015
Primary Outcome: Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses
Secondary Outcome: Effect of bovine lactoferrin on lipid peroxidation byproducts in saliva as measured by the TBARs assay
Study sponsors, principal investigator, and references
Principal Investigator: Glenn Lesser
Lead Sponsor: Wake Forest University Health Sciences
Collaborator: National Cancer Institute (NCI)