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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01941810
First received: September 10, 2013
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Anorexia
Cachexia
Malignant Neoplasm
Oral Complications of Chemotherapy
Biological: bovine lactoferrin supplement
Other: questionnaire administration
Procedure: quality-of-life assessment
Other: laboratory biomarker analysis
Phase 2

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 Cancer Patients Reporting Taste Disturbances While Receiving Chemotherapy

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Change in taste disturbances using the visual analogue scale (VAS) and the Smell and Taste Questionnaire [ Time Frame: Baseline to up to 1 month ] [ Designated as safety issue: No ]
    Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.

  • Change in smell disturbances using the VAS and the Smell and Taste Questionnaire [ Time Frame: Baseline to up to 1 month ] [ Designated as safety issue: No ]
    Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.


Secondary Outcome Measures:
  • Effect of bovine lactoferrin supplement on lipid peroxidation byproducts as measured by the TBARs assay [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
  • Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
  • Smelling loss as quantified by the Brief Smell Identification Test (B-SIT) [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Proportion of patients with vitamin D deficiency [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: February 2014
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (bovine lactoferrin supplement)
Patients receive bovine lactoferrin supplement PO TID for 1 month.
Biological: bovine lactoferrin supplement
Given PO
Other Name: bLF supplement
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941810

Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Glenn J. Lesser    336-716-9527    glesser@wakehealth.edu   
Principal Investigator: Glenn J. Lesser         
United States, Virginia
Virginia Polytechnic Institute and State University Not yet recruiting
Blacksburg, Virginia, United States, 24060
Contact: Andrea M. Dietrich    540-231-5773    andread@vt.edu   
Principal Investigator: Andrea M. Dietrich         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Glenn Lesser Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01941810     History of Changes
Other Study ID Numbers: CCCWFU 98513, NCI-2013-01741, CCCWFU 98513, P30CA012197
Study First Received: September 10, 2013
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Lactoferrin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014