Bovine Lactoferrin Supplement in Improving Taste in Patients With Cancer Receiving Chemotherapy
|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.|
|ClinicalTrials.gov Identifier: NCT01941810|
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Cachexia Malignant Neoplasm Oral Complications of Chemotherapy||Dietary Supplement: bovine lactoferrin supplement Other: questionnaire administration Procedure: quality-of-life assessment Other: laboratory biomarker analysis||Not Applicable|
I. To assess the impact of lactoferrin supplementation (bovine lactoferrin supplement) on self-reported taste and smell disturbances in cancer patients receiving chemotherapy.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Pilot Study of Bovine Lactoferrin in Cancer Patients Reporting Taste Disturbances While Receiving Chemotherapy|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: Supportive care (bovine lactoferrin supplement)
Patients receive bovine lactoferrin supplement PO TID for 1 month.
Dietary Supplement: bovine lactoferrin supplement
Other Name: bLF supplementOther: questionnaire administration
Ancillary studiesProcedure: quality-of-life assessment
Other Name: quality of life assessmentOther: laboratory biomarker analysis
- Change in taste disturbances using the visual analogue scale (VAS) and the Smell and Taste Questionnaire [ Time Frame: Baseline to up to 1 month ]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 ]Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.
- Effect of bovine lactoferrin supplement on lipid peroxidation byproducts as measured by the TBARs assay [ Time Frame: Up to 2 months ]
- Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse [ Time Frame: Up to 2 months ]
- Smelling loss as quantified by the Brief Smell Identification Test (B-SIT) [ Time Frame: Up to 2 months ]
- 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 ]
- Proportion of patients with vitamin D deficiency [ Time Frame: Baseline ]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.
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): NCT01941810
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Virginia|
|Virginia Polytechnic Institute and State University|
|Blacksburg, Virginia, United States, 24060|
|Principal Investigator:||Glenn Lesser||Wake Forest University Health Sciences|