Anorexia | Bovine Lactoferrin Supplement in Improving Taste in Patients With Cancer Receiving Chemotherapy
Anorexia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Oral Complications of Chemotherapy
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:bovine lactoferrin supplementGiven PO
Other:questionnaire administrationAncillary studies
Procedure:quality-of-life assessmentAncillary studies
Other:laboratory biomarker analysisCorrelative studies
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Supportive care (bovine lactoferrin supplement)Patients receive bovine lactoferrin supplement PO TID for 1 month.
Start Date: February 2014
Completed Date: October 2015
Primary Outcome: Change in taste disturbances using the visual analogue scale (VAS) and the Smell and Taste Questionnaire
Secondary Outcome: Effect of bovine lactoferrin supplement on lipid peroxidation byproducts as measured by the TBARs assay
Study sponsors, principal investigator, and references
Principal Investigator: Glenn Lesser
Lead Sponsor: Wake Forest University Health Sciences
Collaborator: National Cancer Institute (NCI)