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).
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.
Study Type
OBSERVATIONAL
Dietary intake assessment conducted by a Registered Dietitian Nutritionist. This assessment will occur prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
Measurement of grip strength using a hand dynamometer. This will test occur prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
Survey about physical activity over the previous 7 days. This survey will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
Milken Institute School of Public Health, George Washington University
Washington D.C., District of Columbia, United States
Change in lean body mass (LBM) from baseline to end of R-CHOP chemotherapy
change in kilograms of lean body mass as measured from staging CT-scans from pre- to post-R-CHOP chemotherapy.
Time frame: baseline and post-R-CHOP chemotherapy (18 weeks)
Change in adipose tissue volume from baseline to end of R-CHOP chemotherapy
change in adipose tissue volume (cm\^3) as measured from staging CT-scans from pre- to post-R-CHOP chemotherapy.
Time frame: baseline and post-R-CHOP chemotherapy (18 weeks)
Change in dietary energy from baseline to end of R-CHOP chemotherapy
Change in total energy intake (kcal/day) from pre- to post-R-CHOP chemotherapy.
Time frame: baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks)
Change in dietary protein intake from baseline to end of R-CHOP chemotherapy
Change in dietary protein intake (g/day) from pre- to post-R-CHOP chemotherapy measured by diet history.
Time frame: 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
Change in daily metabolic equivalents (MET) of physical activity as measured by accelerometer from pre- to post-R-CHOP chemotherapy.
Time frame: baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks)
Change in urinary bisphenol levels
percent of change in urinary bisphenol levels (ng/mL) as measured by liquid chromotography-tandem mass spectrometry from pre- to post-R-CHOP chemotherapy
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Survey about symptoms and side effects experienced during cancer treatment. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
Survey about sleep habits and quality over the past month. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
Survey about quality of life for people with a diagnosis of lymphoma. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
Collect three urine samples either in the clinic or at home. This specimen collection will occur prior to starting R-CHOP chemotherapy, after the third round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
Collect a fecal sample either in the clinic or at home. This sample collection will occur prior to starting R-CHOP chemotherapy, after the third round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
Time frame: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)
Change in urinary phthalate levels
percent of change in urinary phthalate levels (ng/ML) as measured by liquid chromotography-tandem mass spectrometry from pre- to post-R-CHOP chemotherapy
Time frame: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)
Change in gut microbiome composition
Change in species and type of gut microbiota from pre- to post-R-CHOP chemotherapy
Time frame: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)