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

NCT ID: NCT01941810

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-10-31

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.

Conditions

Anorexia; Cachexia; Malignant Neoplasm; Oral Complications of Chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive care (bovine lactoferrin supplement)

Patients receive bovine lactoferrin supplement PO TID for 1 month.

Group Type: EXPERIMENTAL

bovine lactoferrin supplement

Intervention Type: DIETARY_SUPPLEMENT

Given PO

questionnaire administration

Intervention Type: OTHER

Ancillary studies

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

bovine lactoferrin supplement

Given PO

Intervention Type: DIETARY_SUPPLEMENT

questionnaire administration

Ancillary studies

Intervention Type: OTHER

quality-of-life assessment

Ancillary studies

Intervention Type: PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

bLF supplement; quality of life assessment

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glenn Lesser

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, United States

Countries

United States

Other Identifiers

NCI-2013-01741

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 98513

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00025192

Identifier Type: -

Identifier Source: org_study_id