Anorexia, Cachexia, Malignant Neoplasm, Oral Complications of Chemotherapy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTbovine lactoferrin supplement
Given PO
OTHERquestionnaire administration
Ancillary studies
PROCEDUREquality-of-life assessment
Ancillary studies
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in smell disturbances using the VAS and the Smell and Taste Questionnaire | Baseline to up to 1 month | Tested separately by using paired t-tests to assess the significance of the baseline to one month changes. |
| Change in taste disturbances using the visual analogue scale (VAS) and the Smell and Taste Questionnaire | Baseline to up to 1 month | Tested separately by using paired t-tests to assess the significance of the baseline to one month changes. |
Secondary
| Measure | Time frame |
|---|---|
| Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse | 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 |
| Smelling loss as quantified by the Brief Smell Identification Test (B-SIT) | Up to 2 months |
| Effect of bovine lactoferrin supplement on lipid peroxidation byproducts as measured by the TBARs assay | Up to 2 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with vitamin D deficiency | Baseline | 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. |
Countries
United States
Outcome results
None listed