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

Primary Purpose

Anorexia, Cachexia, Malignant Neoplasm

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

bovine lactoferrin supplement

questionnaire administration

quality-of-life assessment

laboratory biomarker analysis

About this trial

This is an interventional supportive care trial for Anorexia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Comprehensive Cancer Center of Wake Forest University
Virginia Polytechnic Institute and State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (bovine lactoferrin supplement)

Arm Description

Patients receive bovine lactoferrin supplement PO TID for 1 month.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse

Smelling loss as quantified by the Brief Smell Identification Test (B-SIT)

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

Full Information

NCT ID

NCT01941810

First Posted

September 10, 2013

Last Updated

July 2, 2018

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01941810

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorexia, Cachexia, Malignant Neoplasm, Oral Complications of Chemotherapy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Supportive care (bovine lactoferrin supplement)

Arm Type

Experimental

Arm Description

Patients receive bovine lactoferrin supplement PO TID for 1 month.

Intervention Type

Dietary Supplement

Intervention Name(s)

bovine lactoferrin supplement

Other Intervention Name(s)

bLF supplement

Intervention Description

Given PO

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Description

Ancillary studies

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Other Intervention Name(s)

quality of life assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Description

Correlative studies

Primary Outcome Measure Information:

Title

Change in taste disturbances using the visual analogue scale (VAS) and the Smell and Taste Questionnaire

Description

Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.

Time Frame

Baseline to up to 1 month

Title

Change in smell disturbances using the VAS and the Smell and Taste Questionnaire

Description

Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.

Time Frame

Baseline to up to 1 month

Secondary Outcome Measure Information:

Title

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

Time Frame

Up to 2 months

Title

Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse

Time Frame

Up to 2 months

Title

Smelling loss as quantified by the Brief Smell Identification Test (B-SIT)

Time Frame

Up to 2 months

Title

Time Frame

Up to 2 months

Other Pre-specified Outcome Measures:

Title

Proportion of patients with vitamin D deficiency

Description

The estimated proportion deficient will be calculated as the number deficient divided by the total number of patients. An exact binomial 95% confidence interval will be calculated for this estimate.

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Glenn Lesser

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Comprehensive Cancer Center of Wake Forest University

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Virginia Polytechnic Institute and State University

City

Blacksburg

State/Province

Virginia

ZIP/Postal Code

24060

Country

United States

12. IPD Sharing Statement

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

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