Bovine Lactoferrin Supplement in Improving Taste in Patients With Cancer Receiving Chemotherapy

PRIMARY OBJECTIVES:

I. To assess the impact of lactoferrin supplementation (bovine lactoferrin supplement) on
self-reported taste and smell disturbances in cancer patients receiving chemotherapy.

SECONDARY OBJECTIVES:

I. To assess the impact of lactoferrin supplementation on the baseline lipid peroxidation
byproducts in saliva in cancer patients as measured by the thiobarbituric acid reactive
substances (TBARs) assay.

II. To assess the impact of lactoferrin supplementation on the ability of cancer 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 cancer patients with
established chemotherapy-induced taste disturbances.

IV. To assess the incidence of vitamin D deficiency in cancer patients with chemotherapy
induced taste changes.

OUTLINE:

Patients receive bovine lactoferrin supplement orally (PO) three times daily (TID) for 1
month.

After completion of study treatment, patients are followed up at 2 weeks and 1 month.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed carcinoma of any site;
the two exceptions are pancreatic cancer and colon cancer patients who are receiving
oxaliplatin; those patients will be ineligible for participation in this current study
but will be eligible for Comprehensive Cancer Center of Wake Forest University
(CCCWFU) 98112 instead

- There are no restrictions on the amount or types of prior therapy; eligible patients
must be receiving ongoing chemotherapy that is planned to continue for at least one
month following enrollment in this trial; any dose or schedule of chemotherapy
administration is allowed as long as patients have self-reported taste disturbance
that has either: 1) developed since the initiation of chemotherapy, or 2) a
pre-existing, treatment-induced taste disturbance has subjectively worsened since
initiating chemotherapy

- Patients must have normal baseline self-reported taste perception prior to the
development of cancer

- 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 pregnant or breastfeeding are excluded