Prospective Observational Study of Diet, Physical Activity and Body Composition Changes During R-CHOP Treatment for NHL
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Non-Hodgkin Lymphoma
- Sponsor
- George Washington University
- Locations
- 1
- Primary Endpoint
- Change in lean body mass (LBM) from baseline to end of R-CHOP chemotherapy
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Kimberly Robien
Associate Professor
George Washington University
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of one of the non-Hodgkin lymphomas
- •Scheduled to receive R-CHOP at the George Washington University Cancer Center
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in lean body mass (LBM) from baseline to end of R-CHOP chemotherapy
Time Frame: 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.
Secondary Outcomes
- 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))