Bovine Lactoferrin in Reducing Taste Disturbances in Patients With Colorectal Cancer Receiving Oxaliplatin-Based Chemotherapy

Wake Forest University (WFU)

Status

Completed

Conditions

Oral Complications of Chemotherapy

Dysgeusia

Colorectal Cancer

Treatments

Procedure: quality-of-life assessment

Other: laboratory biomarker analysis

Dietary Supplement: bovine lactoferrin

Other: questionnaire administration

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01596634

CCCWFU 98112 (Other Identifier)

IRB00020136

NCI-2012-00279 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
- 1. 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 known to be pregnant or who are breastfeeding are excluded