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Bovine Lactoferrin in Reducing Taste Disturbances in Patients With Colorectal Cancer Receiving Oxaliplatin-Based Chemotherapy

Primary Purpose

Colorectal Cancer, Dysgeusia, Oral Complications of Chemotherapy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

questionnaire administration

quality-of-life assessment

laboratory biomarker analysis

bovine lactoferrin

About this trial

This is an interventional supportive care trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must have histologically or cytologically confirmed colorectal carcinoma
There are no restrictions on the amount or types of prior therapy
Eligible patients must be receiving ongoing chemotherapy with an oxaliplatin containing-regimen which is planned to continue for at least one month following enrollment in this trial
Any dose or schedule of oxaliplatin administration is allowed as long as patients have self-reported taste disturbance that has either:
- 1) developed since the initiation of oxaliplatin-based therapy, or
- 2) a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating oxaliplatin-based therapy
Patients must have normal baseline self-reported taste perception prior to the development of colorectal carcinoma
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 known to be pregnant or who are breastfeeding are excluded

Sites / Locations

Comprehensive Cancer Center of Wake Forest University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (bovine lactoferrin)

Arm Description

Patients receive bovine lactoferrin PO (rinse or tablet) TID for 1 month. Treatment continues in the absence of unacceptable toxicity.

Outcomes

Primary Outcome Measures

Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses

Paired-tests will be used to assess the significance of these changes. Linear regression models will be used to determine which patient covariates are associated with change. Repeated measures models will also be used to assess the changes over time using all the repeated measures and contrasts will be used to assess individual pair-wise differences. Descriptive reports will consist of summary statistics (means, standard deviations, proportions, etc.).

Secondary Outcome Measures

Effect of bovine lactoferrin on lipid peroxidation byproducts in saliva as measured by the TBARs assay

Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse

Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) questionnaire

Full Information

NCT ID

NCT01596634

First Posted

May 9, 2012

Last Updated

July 2, 2018

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01596634

Brief Title

Bovine Lactoferrin in Reducing Taste Disturbances in Patients With Colorectal Cancer Receiving Oxaliplatin-Based Chemotherapy

Official Title

A Pilot Study of Bovine Lactoferrin in Patients With Colorectal Carcinoma Receiving Oxaliplatin-Based Chemotherapy and Self-Reported Taste Disturbances

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

January 2013 (Actual)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

October 10, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this research study is to determine if using a lactoferrin supplement will improve taste perception. Lactoferrin is a type of protein that is naturally produced in the body and is commonly found in saliva.

Detailed Description

PRIMARY OBJECTIVES: I. To assess the impact of lactoferrin (bovine lactoferrin) supplementation on self-reported taste and smell disturbances in patients with colorectal cancer receiving oxaliplatin-based chemotherapy SECONDARY OBJECTIVES: I. To assess the impact of lactoferrin supplementation on the baseline lipid peroxidation byproducts in saliva in these patients as measured by the thiobarbituric acid-reactive substances (TBARs) assay. II. To assess the impact of lactoferrin supplementation on the ability of these 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 patients with established chemotherapy-induced taste disturbances. IV. To assess the incidence of vitamin D deficiency in patients with oxaliplatin-based therapy induced taste changes OUTLINE: Patients receive bovine lactoferrin orally (PO) (rinse or tablet) thrice daily (TID) for 1 month. Treatment continues in the absence of unacceptable toxicity. After completion of study treatment, patients are followed up at 2 and 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Dysgeusia, Oral Complications of Chemotherapy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Supportive care (bovine lactoferrin)

Arm Type

Experimental

Arm Description

Patients receive bovine lactoferrin PO (rinse or tablet) TID for 1 month. Treatment continues in the absence of unacceptable toxicity.

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Description

Ancillary studies

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Other Intervention Name(s)

quality of life assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Description

Correlative studies

Intervention Type

Dietary Supplement

Intervention Name(s)

bovine lactoferrin

Intervention Description

Given PO

Primary Outcome Measure Information:

Title

Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses

Description

Time Frame

Approximately 1 month

Secondary Outcome Measure Information:

Title

Effect of bovine lactoferrin on lipid peroxidation byproducts in saliva as measured by the TBARs assay

Time Frame

Approximately 2 months

Title

Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse

Time Frame

Approximately 2 months

Title

Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) questionnaire

Time Frame

Approximately 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have histologically or cytologically confirmed colorectal carcinoma There are no restrictions on the amount or types of prior therapy Eligible patients must be receiving ongoing chemotherapy with an oxaliplatin containing-regimen which is planned to continue for at least one month following enrollment in this trial Any dose or schedule of oxaliplatin administration is allowed as long as patients have self-reported taste disturbance that has either: 1) developed since the initiation of oxaliplatin-based therapy, or 2) a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating oxaliplatin-based therapy Patients must have normal baseline self-reported taste perception prior to the development of colorectal carcinoma 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 known to be pregnant or who are breastfeeding are excluded

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Glenn Lesser

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Comprehensive Cancer Center of Wake Forest University

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Bovine Lactoferrin in Reducing Taste Disturbances in Patients With Colorectal Cancer Receiving Oxaliplatin-Based Chemotherapy

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