NCT01596634

Brief Summary

The purpose of this research study is to determine if using a lactoferrin supplement will improve taste perception. Lactoferrin is a type of protein that is naturally produced in the body and is commonly found in saliva.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2015

Completed
Last Updated

July 3, 2018

Status Verified

July 1, 2018

Enrollment Period

2.6 years

First QC Date

May 9, 2012

Last Update Submit

July 2, 2018

Conditions

Colorectal CancerDysgeusiaOral Complications of Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses

    Paired-tests will be used to assess the significance of these changes. Linear regression models will be used to determine which patient covariates are associated with change. Repeated measures models will also be used to assess the changes over time using all the repeated measures and contrasts will be used to assess individual pair-wise differences. Descriptive reports will consist of summary statistics (means, standard deviations, proportions, etc.).

    Approximately 1 month

Secondary Outcomes (3)

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

    Approximately 2 months

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

    Approximately 2 months

  • Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) questionnaire

    Approximately 2 months

Study Arms (1)

Supportive care (bovine lactoferrin)

EXPERIMENTAL

Patients receive bovine lactoferrin PO (rinse or tablet) TID for 1 month. Treatment continues in the absence of unacceptable toxicity.

Other: questionnaire administrationProcedure: quality-of-life assessmentOther: laboratory biomarker analysisDietary Supplement: bovine lactoferrin

Interventions

questionnaire administrationOTHER

Ancillary studies

Supportive care (bovine lactoferrin)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Supportive care (bovine lactoferrin)
laboratory biomarker analysisOTHER

Correlative studies

Supportive care (bovine lactoferrin)
bovine lactoferrinDIETARY_SUPPLEMENT

Given PO

Supportive care (bovine lactoferrin)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have histologically or cytologically confirmed colorectal carcinoma
  • There are no restrictions on the amount or types of prior therapy
  • Eligible patients must be receiving ongoing chemotherapy with an oxaliplatin containing-regimen which is planned to continue for at least one month following enrollment in this trial
  • Any dose or schedule of oxaliplatin administration is allowed as long as patients have self-reported taste disturbance that has either:
  • \) developed since the initiation of oxaliplatin-based therapy, or
  • \) a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating oxaliplatin-based therapy
  • Patients must have normal baseline self-reported taste perception prior to the development of colorectal carcinoma
  • 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 known to be pregnant or who are breastfeeding are excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsDysgeusia

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesTaste DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

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

May 9, 2012

First Posted

May 11, 2012

Study Start

January 1, 2013

Primary Completion

August 1, 2015

Study Completion

October 10, 2015

Last Updated

July 3, 2018

Record last verified: 2018-07

Locations

US(1)