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

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.

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