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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01741 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 98513 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
I. To assess the impact of lactoferrin supplementation (bovine lactoferrin supplement) on self-reported taste and smell disturbances in cancer patients receiving chemotherapy.
SECONDARY OBJECTIVES:
I. To assess the impact of lactoferrin supplementation on the baseline lipid peroxidation byproducts in saliva in cancer patients as measured by the thiobarbituric acid reactive substances (TBARs) assay.
II. To assess the impact of lactoferrin supplementation on the ability of cancer 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 cancer patients with established chemotherapy-induced taste disturbances.
IV. To assess the incidence of vitamin D deficiency in cancer patients with chemotherapy induced taste changes.
OUTLINE:
Patients receive bovine lactoferrin supplement orally (PO) three times daily (TID) for 1 month.
After completion of study treatment, patients are followed up at 2 weeks and 1 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (bovine lactoferrin supplement) | Experimental | Patients receive bovine lactoferrin supplement PO TID for 1 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bovine lactoferrin supplement | Dietary Supplement | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in taste disturbances using the visual analogue scale (VAS) and the Smell and Taste Questionnaire | Tested separately by using paired t-tests to assess the significance of the baseline to one month changes. | Baseline to up to 1 month |
| Change in smell disturbances using the VAS and the Smell and Taste Questionnaire | Tested separately by using paired t-tests to assess the significance of the baseline to one month changes. | Baseline to up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of bovine lactoferrin supplement on lipid peroxidation byproducts as measured by the TBARs assay | Up to 2 months | |
| Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse | Up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with vitamin D deficiency | The estimated proportion deficient will be calculated as the number deficient divided by the total number of patients. An exact binomial 95% confidence interval will be calculated for this estimate. | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Lesser | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States | ||
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| questionnaire administration | Other | Ancillary studies |
|
| quality-of-life assessment | Procedure | Ancillary studies |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Smelling loss as quantified by the Brief Smell Identification Test (B-SIT) | Up to 2 months |
| Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaires | Up to 2 months |
| Virginia Polytechnic Institute and State University |
| Blacksburg |
| Virginia |
| 24060 |
| United States |
| ID | Term |
|---|---|
| D000855 | Anorexia |
| D002100 | Cachexia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D013851 | Thinness |
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