Clinical trial · Interventional
Bovine Lactoferrin in Reducing Taste Disturbances in Patients With Colorectal Cancer Receiving Oxaliplatin-Based Chemotherapy
A Pilot Study of Bovine Lactoferrin in Patients With Colorectal Carcinoma Receiving Oxaliplatin-Based Chemotherapy and Self-Reported Taste Disturbances
NCT01596634CI-TRIAL-00033564completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Dysgeusia | — | UNRESOLVED | — |
| Oral Complications of Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bovine lactoferrin | Dietary Supplement | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (bovine lactoferrin)
- description
- Patients receive bovine lactoferrin PO (rinse or tablet) TID for 1 month. Treatment continues in the absence of unacceptable toxicity.
- interventionNames
- Other: questionnaire administration
- Procedure: quality-of-life assessment
- Other: laboratory biomarker analysis
- Dietary Supplement: bovine lactoferrin
Primary outcomes (1)
- measure
- Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses
- timeFrame
- Approximately 1 month
- 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.).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 known to be pregnant or who are breastfeeding are excluded
References
Publications (0)
Data not yet available
No reference posted for this study.