Prospective Observational Study of Diet, Physical Activity and Body Composition Changes During R-CHOP Treatment for NHL
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in lean body mass (LBM) from baseline to end of R-CHOP chemotherapy
研究概览
简要总结
In this pilot study, observational data will be collected to describe the usual trajectory of changes in dietary intake, ability to be physically active, body composition, environmental exposures, and the gut microbiome over the course of R-CHOP treatment for non-Hodgkin lymphoma (NHL).
详细描述
Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is the "gold standard" first-line treatment for patients with non-Hodgkin lymphoma, yet it is estimated that R-CHOP is not curative for 30- 50% of patients. Preliminary studies suggests that modifiable lifestyle factors such as body composition, exposure to endocrine disrupting chemicals, and changes in the gut microbiome may contribute to variation in R-CHOP treatment response. If true, it could be possible to modify these factors in an effort to improve treatment outcomes, however more detailed information is needed to confirm these preliminary findings and test whether lifestyle modification can improve outcomes.
In this observational study, data will be collected on dietary intake, ability to be physically active, body composition, environmental exposure to endocrine disrupting chemicals and changes in the gut microbiome over the course of R-CHOP for NHL. The study will provide more detailed information on the usual trajectory of these lifestyle factors during R-CHOP treatment than has previously been collected, especially how these factors co-vary over time. The study findings are expected to inform future intervention studies aimed at improving R-CHOP treatment outcomes.
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
- •Diagnosis of one of the non-Hodgkin lymphomas
- •Scheduled to receive R-CHOP at the George Washington University Cancer Center
排除标准
- •Diagnosis of cancer other than one of the non-Hodgkin lymphomas
- •Patients who are scheduled to receive their R-CHOP somewhere other than the George Washington University Cancer Center
- •Patients who are not competent to provide informed consent to participate
结局指标
主要结局
Change in lean body mass (LBM) from baseline to end of R-CHOP chemotherapy
时间窗: baseline and post-R-CHOP chemotherapy (18 weeks)
change in kilograms of lean body mass as measured from staging CT-scans from pre- to post-R-CHOP chemotherapy.
次要结局
- Change in urinary phthalate levels(baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks))
- Change in adipose tissue volume from baseline to end of R-CHOP chemotherapy(baseline and post-R-CHOP chemotherapy (18 weeks))
- Change in dietary energy from baseline to end of R-CHOP chemotherapy(baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks))
- Change in physical activity level from baseline to end of R-CHOP chemotherapy(baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks))
- Change in gut microbiome composition(baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks))
- Change in dietary protein intake from baseline to end of R-CHOP chemotherapy(baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks))
- Change in urinary bisphenol levels(baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks))
研究者
Kimberly Robien
Associate Professor
George Washington University