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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University Identifier:
First received: May 9, 2012
Last updated: October 29, 2015
Last verified: October 2015
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
Oral Complications of Chemotherapy
Other: questionnaire administration
Procedure: quality-of-life assessment
Other: laboratory biomarker analysis
Biological: bovine lactoferrin

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses [ Time Frame: Approximately 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]
  • Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) questionnaire [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 49
Study Start Date: January 2013
Estimated Primary Completion Date: August 2016 (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
Biological: bovine lactoferrin
Given PO

Detailed Description:


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


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


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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01596634

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

Responsible Party: Comprehensive Cancer Center of Wake Forest University Identifier: NCT01596634     History of Changes
Other Study ID Numbers: CCCWFU 98112  NCI-2012-00279 
Study First Received: May 9, 2012
Last Updated: October 29, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Nervous System Diseases
Neurologic Manifestations
Rectal Diseases
Sensation Disorders
Signs and Symptoms
Taste Disorders
Anti-Infective Agents processed this record on May 25, 2016