Bovine Lactoferrin Supplement in Improving Taste in Patients With Cancer Receiving Chemotherapy
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.
Oral Complications of Chemotherapy
Biological: bovine lactoferrin supplement
Other: questionnaire administration
Procedure: quality-of-life assessment
Other: laboratory biomarker analysis
|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|
- 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.
- 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 ]
- 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.
|Study Start Date:||February 2014|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Experimental: Supportive care (bovine lactoferrin supplement)
Patients receive bovine lactoferrin supplement PO TID for 1 month.
Biological: bovine lactoferrin supplement
Other Name: bLF supplementOther: questionnaire administration
Ancillary studiesProcedure: quality-of-life assessment
Other Name: quality of life assessmentOther: laboratory biomarker analysis
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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||Comprehensive Cancer Center of Wake Forest University|