A Pilot Study of Bovine Lactoferrin in Cancer Patients Reporting Taste Disturbances While Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Change in smell disturbances using the VAS and the Smell and Taste Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Supportive care (bovine lactoferrin supplement)
Patients receive bovine lactoferrin supplement PO TID for 1 month.
干预措施: questionnaire administration (Other)
Supportive care (bovine lactoferrin supplement)
Patients receive bovine lactoferrin supplement PO TID for 1 month.
干预措施: quality-of-life assessment (Procedure)
Supportive care (bovine lactoferrin supplement)
Patients receive bovine lactoferrin supplement PO TID for 1 month.
干预措施: laboratory biomarker analysis (Other)
Supportive care (bovine lactoferrin supplement)
Patients receive bovine lactoferrin supplement PO TID for 1 month.
干预措施: bovine lactoferrin supplement (Dietary Supplement)
结局指标
主要结局
Change in smell disturbances using the VAS and the Smell and Taste Questionnaire
时间窗: 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
时间窗: Baseline to up to 1 month
Tested separately by using paired t-tests to assess the significance of the baseline to one month changes.
次要结局
- Effect of bovine lactoferrin supplement on lipid peroxidation byproducts as measured by the TBARs assay(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)
- Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse(Up to 2 months)