Associations Between Diet, Hepcidin, and Relative Dose Intensity Among Women Receiving Chemotherapy for Breast or Gynecological Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Chemotherapy relative dose intensity
研究概览
简要总结
This prospective, observational cohort study will evaluate the extent of associations between self-reported pro- or anti- inflammatory dietary intake patterns for one month before induction chemotherapy for gynecological cancer or neo/adjuvant chemotherapy for breast cancer and baseline serum hepcidin concentrations. Associations between hepcidin concentration and relative dose intensity (RDI) of chemotherapy will also be evaluated.
详细描述
This is a prospective, observational cohort of 100 women receiving chemotherapy for breast or gynecological cancer at GW Cancer Center from July 1, 2024 - approximately September 2025. At study baseline (after diagnosis, but prior to starting chemotherapy), participants will complete a ~30-minute food frequency questionnaire (FFQ) and demographic/food security survey using a preprogrammed iPad in the clinic. The clinical research nurse will obtain an additional research blood draw at the same time as the patient's routine clinical blood draw prior to chemotherapy initiation for serum hepcidin concentration measurement. Data on cancer type, premorbid medical conditions, and chemotherapy plans and administration will be collected from the electronic health record by study staff and the duration of data collection will be the length of chemotherapy plus 30 days. Data will be used to address the objectives below.
Among adult women scheduled to receive chemotherapy for breast or gynecological cancer treatment, the objectives/aims of this study will be to:
- Determine the extent to which pretreatment, self-reported Dietary Inflammatory Index dietary pattern scores from dietary intake during the one month prior to chemotherapy initiation are associated with pretreatment serum hepcidin concentrations
- Determine the extent to which pretreatment serum hepcidin concentrations are associated with chemotherapy RDI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with invasive breast cancer, OR
- •Have been diagnosed with epithelial ovarian cancer, fallopian tube or primary peritoneal cancer, OR
- •Have been diagnosed with endometrial cancer
- •Are chemotherapy-naïve
- •Are scheduled to receive neoadjuvant chemotherapy (or adjuvant chemotherapy following lumpectomy for breast cancer patients) or neoadjuvant/induction chemotherapy for gynecological cancer at GW Cancer Center
排除标准
- •Prior primary hematological condition that would cause abnormal blood counts (e.g. leukemia)
- •Pregnant at the time of potential enrollment
- •Receipt of erythropoietin-stimulating agents or blood transfusion in the 6 weeks prior to initial testing
- •Women who are cognitively unable to provide a diet history for the month prior to assessment.
结局指标
主要结局
Chemotherapy relative dose intensity
时间窗: during chemotherapy (up to 6 months, depends on duration of chemotherapy regimen), represents repeated measures
Calculated variable that represents the ratio of chemotherapy actually received during the duration of treatment to the planned chemotherapy dose during the planned duration
Serum hepcidin concentration
时间窗: pre-chemotherapy, single measure
ng/ml, continuous
次要结局
- Hematologic toxicity(at any point during chemotherapy or within 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen))
- Treatment delays(at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen))
- Treatment change or discontinuation(at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen))
- Blood transfusion(at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen))
- Hospitalizations(at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen))
研究者
Kimberly Robien
Associate Professor
George Washington University