This pilot phase II trial studies how well bovine lactoferrin supplement works in improving taste in patients with cancer receiving chemotherapy. Bovine lactoferrin supplement may help improve the ability to taste food in patients who are 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
14
Given PO
Ancillary studies
Ancillary studies
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Virginia Polytechnic Institute and State University
Blacksburg, Virginia, United States
Change in taste disturbances using the visual analogue scale (VAS) and the Smell and Taste Questionnaire
Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.
Time frame: Baseline to up to 1 month
Change in smell disturbances using the VAS and the Smell and Taste Questionnaire
Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.
Time frame: Baseline to up to 1 month
Effect of bovine lactoferrin supplement on lipid peroxidation byproducts as measured by the TBARs assay
Time frame: Up to 2 months
Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse
Time frame: Up to 2 months
Smelling loss as quantified by the Brief Smell Identification Test (B-SIT)
Time frame: Up to 2 months
Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaires
Time frame: Up to 2 months
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