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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01596634
First Posted: May 11, 2012
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose
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.

Condition Intervention
Colorectal Cancer Dysgeusia Oral Complications of Chemotherapy Other: questionnaire administration Procedure: quality-of-life assessment Other: laboratory biomarker analysis Dietary Supplement: bovine lactoferrin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Bovine Lactoferrin in Patients With Colorectal Carcinoma Receiving Oxaliplatin-Based Chemotherapy and Self-Reported Taste Disturbances

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses [ Time Frame: Approximately 1 month ]
    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 [ Time Frame: Approximately 2 months ]
  • Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse [ Time Frame: Approximately 2 months ]
  • Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) questionnaire [ Time Frame: Approximately 2 months ]

Enrollment: 12
Actual Study Start Date: January 2013
Study Completion Date: October 10, 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (bovine lactoferrin)
Patients receive bovine lactoferrin PO (rinse or tablet) TID for 1 month. Treatment continues in the absence of unacceptable toxicity.
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: laboratory biomarker analysis
Correlative studies
Dietary Supplement: bovine lactoferrin
Given PO

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596634


Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Glenn Lesser Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01596634     History of Changes
Other Study ID Numbers: CCCWFU 98112
NCI-2012-00279 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: May 9, 2012
First Posted: May 11, 2012
Last Update Posted: May 30, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Dysgeusia
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Taste Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Oxaliplatin
Lactoferrin
Antineoplastic Agents
Anti-Infective Agents