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

Not Applicable

Completed

Conditions: Oral Complications of Chemotherapy
Cachexia
Anorexia
Malignant Neoplasm

Interventions: Dietary Supplement: bovine lactoferrin supplement
Other: questionnaire administration
Procedure: quality-of-life assessment
Other: laboratory biomarker analysis

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Supportive care (bovine lactoferrin supplement)	bovine lactoferrin supplement	Patients receive bovine lactoferrin supplement PO TID for 1 month.
Supportive care (bovine lactoferrin supplement)	quality-of-life assessment	Patients receive bovine lactoferrin supplement PO TID for 1 month.
Supportive care (bovine lactoferrin supplement)	laboratory biomarker analysis	Patients receive bovine lactoferrin supplement PO TID for 1 month.
Supportive care (bovine lactoferrin supplement)	questionnaire administration	Patients receive bovine lactoferrin supplement PO TID for 1 month.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Effect of bovine lactoferrin supplement on lipid peroxidation byproducts as measured by the TBARs assay	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

Locations (2): Comprehensive Cancer Center of Wake Forest University
🇺🇸
Winston-Salem, North Carolina, United States
Virginia Polytechnic Institute and State University
🇺🇸
Blacksburg, Virginia, United States