NCT01941810

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

A Pilot Study of Bovine Lactoferrin in Cancer Patients Reporting Taste Disturbances While Receiving Chemotherapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anorexia
• Cachexia
• Malignant Neoplasm
• Oral Complications of Chemotherapy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	bovine lactoferrin supplement	Given PO
OTHER	questionnaire administration	Ancillary studies
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-09-13
• Last updated: 2018-07-03

Locations

2 sites across 1 country: United States