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Keep this study
Lead
Wake Forest University Health Sciences
With
National Cancer Institute (NCI)
PRIMARY OBJECTIVES:
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
SECONDARY OBJECTIVES:
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
OUTLINE:
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Bovine Lactoferrin in Reducing Taste Disturbances in Patients With Colorectal Cancer Receiving Oxaliplatin-Based Chemotherapy
