This trial is active, not recruiting.

Conditions anorexia, cachexia, malignant neoplasm, oral complications of chemotherapy
Treatments bovine lactoferrin supplement, questionnaire administration, quality-of-life assessment, laboratory biomarker analysis
Phase phase 2
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date February 2014
End date October 2015
Trial size 30 participants
Trial identifier NCT01941810, CCCWFU 98513, NCI-2013-01741, P30CA012197


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Patients receive bovine lactoferrin supplement PO TID for 1 month.
bovine lactoferrin supplement bLF supplement
Given PO
questionnaire administration
Ancillary studies
quality-of-life assessment quality of life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Change in taste disturbances using the visual analogue scale (VAS) and the Smell and Taste Questionnaire
time frame: Baseline to up to 1 month
Change in smell disturbances using the VAS and the Smell and Taste Questionnaire
time frame: Baseline to up to 1 month

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Pilot Study of Bovine Lactoferrin in Cancer Patients Reporting Taste Disturbances While Receiving Chemotherapy
Principal investigator Glenn Lesser
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.
Location data was received from the National Cancer Institute and was last updated in August 2016.