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.
Other: questionnaire administration
Procedure: quality-of-life assessment
Other: laboratory biomarker analysis
: bovine lactoferrin
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Locations near you
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Full eligibility criteria for NCT01596634
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT01596634
United States (1)
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
View full eligibility
Tris trial is registered with FDA with number: NCT01596634. The sponsor of the trial is Wake Forest University Health Sciences and it is looking for 12 volunteers for the current phase.
Official trial title: A Pilot Study of Bovine Lactoferrin in Patients With Colorectal Carcinoma Receiving Oxaliplatin-Based Chemotherapy and Self-Reported Taste Disturbances
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