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

NCT01941810 | Completed

• 4 other identifiers: IRB00025192NCI-2013-01741CCCWFU 98513P30CA012197
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Anorexia; Cachexia; Malignant Neoplasm; Oral Complications of Chemotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to up to 1 month

• 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.

  Baseline to up to 1 month

Secondary Outcomes (4)

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

  Up to 2 months

• 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

• 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

Other Outcomes (1)

• Proportion of patients with vitamin D deficiency

  Baseline

Study Arms (1)

Supportive care (bovine lactoferrin supplement)

EXPERIMENTAL

Patients receive bovine lactoferrin supplement PO TID for 1 month.

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

Interventions

bovine lactoferrin supplement DIETARY_SUPPLEMENT

Given PO

Also known as: bLF supplement

Supportive care (bovine lactoferrin supplement)

questionnaire administration OTHER

Ancillary studies

Supportive care (bovine lactoferrin supplement)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Supportive care (bovine lactoferrin supplement)

laboratory biomarker analysis OTHER

Correlative studies

Supportive care (bovine lactoferrin supplement)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, 24060, United States

Location

MeSH Terms

Conditions

Anorexia; Cachexia; Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Thinness

Study Officials

• Glenn Lesser

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 13, 2013
• Study Start: February 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: July 3, 2018

Record last verified: 2018-07

Locations

US (2)