Clinical trial · Interventional
Bovine Lactoferrin Supplement in Improving Taste in Patients With Cancer Receiving Chemotherapy
A Pilot Study of Bovine Lactoferrin in Cancer Patients Reporting Taste Disturbances While Receiving Chemotherapy
NCT01941810CI-TRIAL-00033583completedN/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)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anorexia | — | UNRESOLVED | — |
| Cachexia | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Oral Complications of Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bovine lactoferrin supplement | 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 supplement)
- description
- Patients receive bovine lactoferrin supplement PO TID for 1 month.
- interventionNames
- Dietary Supplement: bovine lactoferrin supplement
- Other: questionnaire administration
- Procedure: quality-of-life assessment
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Change in taste disturbances using the visual analogue scale (VAS) and the Smell and Taste Questionnaire
- timeFrame
- Baseline to up to 1 month
- description
- Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.
- measure
- Change in smell disturbances using the VAS and the Smell and Taste Questionnaire
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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
References
Publications (0)
Data not yet available
No reference posted for this study.