Clinical Trial: Bovine Lactoferrin Supplement in Improving Taste in Patients With Cancer Receiving Chemotherapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Wake Forest University Health Sciences

Current Primary Outcome:

  • Change in taste disturbances using the visual analogue scale (VAS) and the Smell and Taste Questionnaire [ Time Frame: Baseline to up to 1 month ]
    Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.
  • Change in smell disturbances using the VAS and the Smell and Taste Questionnaire [ Time Frame: Baseline to up to 1 month ]
    Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Wake Forest University Health Sciences

Dates:
Date Received: September 10, 2013
Date Started: February 2014
Date Completion:
Last Updated: April 17, 2017
Last Verified: July 2016