An Evaluation of Changes in the Relationships Between Fatigue and Molecular Mechanisms in Cancer Patients Receiving Curative-Intent Combined Chemotherapy and Radiation Therapy (CCRT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Measure associations between changes in cancer-related fatigue (CRF) and changes in gene expression over time
研究概览
简要总结
Cancer-related fatigue (CRF) is a significant problem for cancer patients. This prospective, basic science, observational study will evaluate for changes in CRF associated with molecular characteristics prior to, during, and at the completion of non-investigational, standard-of-care, combined chemotherapy and radiation therapy (CCRT) and to develop and assess predictive models for CRF severity.
详细描述
Primary Objective For mean, morning and evening CRF:
Aim 1. Evaluate for associations between phenotypic characteristics and initial levels and the trajectories of CRF.
Aim 2. Evaluate for associations between changes in CRF severity and changes in gene expression levels prior to the initiation and at the end of CCRT.
Aim 3. Evaluate for associations between changes in CRF severity and changes in circulating free cytokine levels prior to the initiation and at the end of CCRT.
Aim 4. Develop and assess predictive models for CRF severity midway, at the end of, and at least six months post-CCRT using demographic, clinical, and molecular characteristics collected prior the initiation of CCRT.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants have not received any prior treatment (i.e., cancer systemic therapies or radiation therapy) in the month except surgery or inductive Chemotherapy (CTX).
- •Participants receiving >= 15 fractions.
- •Participants is male or female and is >18 years of age on the day of signing the informed consent.
- •Ability to understand a written informed consent document.
- •Able and willing to complete all of the study questionnaires and provide blood and stool samples prior to, midway, and following the completion of treatment.
- •Willing to have medical records reviewed for clinical information.
- •Able to read, write and understand English or Spanish.
排除标准
- •Contraindication to phlebotomy for removal of approximately 50 mL of peripheral blood within 6 week period (Institutional Review Board (IRB) limit).
研究组 & 干预措施
Cancer Patients
Participants will have blood and stool samples collected within 5 days of any pre or post treatment timepoint prior to, during, at completion of therapy and up to 34 weeks following non-investigational, standard of care, CCRT. Participants will also be given quality of life questionnaires to complete throughout the course of the study.
干预措施: Blood Specimen Collection (Procedure)
Cancer Patients
Participants will have blood and stool samples collected within 5 days of any pre or post treatment timepoint prior to, during, at completion of therapy and up to 34 weeks following non-investigational, standard of care, CCRT. Participants will also be given quality of life questionnaires to complete throughout the course of the study.
干预措施: Stool Specimen Collection (Other)
Cancer Patients
Participants will have blood and stool samples collected within 5 days of any pre or post treatment timepoint prior to, during, at completion of therapy and up to 34 weeks following non-investigational, standard of care, CCRT. Participants will also be given quality of life questionnaires to complete throughout the course of the study.
干预措施: Quality of Life (QOL) Questionnaires (Other)
结局指标
主要结局
Measure associations between changes in cancer-related fatigue (CRF) and changes in gene expression over time
时间窗: Up to 34 weeks
Association between phenotypic characteristics and initial levels and trajectories of CRF severity will be assessed using a hierarchical linear model (HLM) approach.
Measure associations between changes in CRF and changes in cytokine levels over time
时间窗: Up to 34 weeks
Association between changes in CRF severity and biomarker levels prior to the initiation and at the end of CCRT. Linear regression will be used to evaluate for associations between fatigue changes and biomarker levels at baseline controlling for covariates identified in the initial primary outcome. Adjustments for multiple comparisons will be conducted using the Benjamini-Hochberg (BH) procedure at a false discovery rate (FDR) of 10%.
Measure associations between changes in CRF and changes in gene expression over time
时间窗: Up to 34 weeks
Association between changes in CRF severity and gene expression prior to the initiation and at the end of CCRT. Linear regression will be used to evaluate for associations between fatigue changes and biomarker levels at baseline controlling for covariates identified in the initial primary outcome. Adjustments for multiple comparisons will be conducted using the Benjamini-Hochberg (BH) procedure at a false discovery rate (FDR) of 10%.
Evaluate the predictive utility of gene expression and cytokine data
时间窗: Up to 34 weeks
A validated prediction model of CRF severity will be generated using machine learning (ML) methods to minimize the error between predicted and observed levels of fatigue midway through CCRT, at the completion of CCRT, and at least six months following the completion of CCRT. Evaluation of common ML algorithms for prediction accuracy and evaluation of model performance as compared to simple linear regression. Separate training and testing sets will be created, cross-validated, and repeated and impact of each variable will be determined.
次要结局
- Evaluate for associations between changes in chemotherapy-induced peripheral neuropathy (CIPN) and changes in gene expression(Up to 34 weeks)
- Evaluate for associations between changes in CIPN and changes in cytokine levels(Up to 34 weeks)
- Evaluate the predictive utility of gene expression and severity of CIPN(Up to 34 weeks)
- Evaluate the predictive utility of cytokine levels and severity of CIPN(Up to 34 weeks)
- Evaluate the predictive model of severity of CIPN(Up to 34 weeks)