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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941810
• Other study ID #: IRB00025192
• Secondary ID: NCI-2013-01741CC
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: October 2015

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Polytechnic Institute and State University	Blacksburg	Virginia
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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