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

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.

Study Overview

• Status: Completed
• Conditions: Anorexia; Cachexia; Malignant Neoplasm; Oral Complications of Chemotherapy
• Intervention / Treatment: Other: laboratory biomarker analysis; Other: questionnaire administration; Procedure: quality-of-life assessment; Dietary supplement: bovine lactoferrin supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • Virginia Polytechnic Institute and State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Supportive care (bovine lactoferrin supplement); Patients receive bovine lactoferrin supplement PO TID for 1 month.	Other: laboratory biomarker analysis; Correlative studies; Other: questionnaire administration; Ancillary studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Dietary supplement: bovine lactoferrin supplement; Given PO; Other Names: bLF supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to up to 1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Effect of bovine lactoferrin supplement on lipid peroxidation byproducts as measured by the TBARs assay	Up to 2 months
Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse	Up to 2 months
Smelling loss as quantified by the Brief Smell Identification Test (B-SIT)	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	Up to 2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with vitamin D deficiency	The estimated proportion deficient will be calculated as the number deficient divided by the total number of patients. An exact binomial 95% confidence interval will be calculated for this estimate.	Baseline

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (ESTIMATE): September 13, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Neoplasms; Anorexia; Cachexia; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: IRB00025192; P30CA012197 (U.S. NIH Grant/Contract); NCI-2013-01741 (REGISTRY: CTRP (Clinical Trial Reporting Program)); CCCWFU 98513 (OTHER: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No