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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study of Bovine Lactoferrin in Cancer Patients Reporting Taste Disturbances While Receiving Chemotherapy

Conditions
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Anorexia, Cachexia, Malignant Neoplasm, Oral Complications of Chemotherapy

Intervention / Treatment
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* Dietary Supplement: bovine lactoferrin supplement
* Other: questionnaire administration
* Procedure: quality-of-life assessment
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (bovine lactoferrin supplement)<br>Patients receive bovine lactoferrin supplement PO TID for 1 month. | Dietary Supplement: bovine lactoferrin supplement<br>* Given PO<br>* Other names: bLF supplement;Other: questionnaire administration<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in taste disturbances using the visual analogue scale (VAS) and the Smell and Taste Questionnaire | Tested separately by using paired t-tests to assess the significance of the baseline to one month changes. | Baseline to up to 1 month | 
| Change in smell disturbances using the VAS and the Smell and Taste Questionnaire | Tested separately by using paired t-tests to assess the significance of the baseline to one month changes. | Baseline to up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of bovine lactoferrin supplement on lipid peroxidation byproducts as measured by the TBARs assay |  | Up to 2 months | 
| Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse |  | Up to 2 months | 
| Smelling loss as quantified by the Brief Smell Identification Test (B-SIT) |  | 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 |  | Up to 2 months |