Bovine Lactoferrin in Reducing Taste Disturbances in Patients With Colorectal Cancer Receiving Oxaliplatin-Based Chemotherapy

Completed · Not applicable

Conditions studied: Colorectal Cancer, Dysgeusia, Oral Complications of Chemotherapy

In brief

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.

Key facts

Study ID

NCT01596634

Run by

Wake Forest University Health Sciences

People needed

12

Starts

2013-01-01

Expected to finish

2015-10-10

Last updated by the study team

2018-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Comprehensive Cancer Center of Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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