Know Cancer

or
forgot password

A Pilot Study of Bovine Lactoferrin in Patients With Colorectal Carcinoma Receiving Oxaliplatin-Based Chemotherapy and Self-Reported Taste Disturbances


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Dysgeusia, Oral Complications of Chemotherapy

Thank you

Trial Information

A Pilot Study of Bovine Lactoferrin in Patients With Colorectal Carcinoma Receiving Oxaliplatin-Based Chemotherapy and Self-Reported Taste Disturbances


PRIMARY OBJECTIVES:

I. To assess the impact of lactoferrin (bovine lactoferrin) supplementation on self-reported
taste and smell disturbances in patients with colorectal cancer receiving oxaliplatin-based
chemotherapy

SECONDARY OBJECTIVES:

I. To assess the impact of lactoferrin supplementation on the baseline lipid peroxidation
byproducts in saliva in these patients as measured by the thiobarbituric acid-reactive
substances (TBARs) assay.

II. To assess the impact of lactoferrin supplementation on the ability of these 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 patients with established
chemotherapy-induced taste disturbances.

IV. To assess the incidence of vitamin D deficiency in patients with oxaliplatin-based
therapy induced taste changes

OUTLINE:

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

After completion of study treatment, patients are followed up at 2 and 4 weeks.


Inclusion Criteria:



- 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:

- 1) developed since the initiation of oxaliplatin-based therapy, or

- 2) 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

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Description:

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.).

Outcome Time Frame:

Approximately 1 month

Safety Issue:

No

Principal Investigator

Glenn Lesser

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 98112

NCT ID:

NCT01596634

Start Date:

January 2013

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Dysgeusia
  • Oral Complications of Chemotherapy
  • Colorectal Neoplasms
  • Dysgeusia

Name

Location

Comprehensive Cancer Center of Wake Forest UniversityWinston-Salem, North Carolina  27157-1082