Clinical trial NCT04293900: Diet, Physical Activity and Body Composition Changes During R-CHOP
Official title: Prospective Observational Study of Diet, Physical Activity and Body Composition Changes During R-CHOP Treatment for NHL
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-Hodgkin Lymphoma
DLBCL
Diffuse Large B Cell Lymphoma
Keywords: diet
physical activity
body composition
bisphenol
phthalate
gut microbiome
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being treated at the George Washington University for non-Hodgkin lymphoma who are scheduled to receive R-CHOP chemotherapy

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.

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

Primary outcomes:
measure: Change in lean body mass (LBM) from baseline to end of R-CHOP chemotherapy
timeFrame: baseline and post-R-CHOP chemotherapy (18 weeks)
Secondary outcomes:
measure: Change in adipose tissue volume from baseline to end of R-CHOP chemotherapy
timeFrame: baseline and post-R-CHOP chemotherapy (18 weeks)
measure: Change in dietary energy from baseline to end of R-CHOP chemotherapy
timeFrame: baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks)
measure: Change in dietary protein intake from baseline to end of R-CHOP chemotherapy
timeFrame: baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks)
measure: Change in physical activity level from baseline to end of R-CHOP chemotherapy
timeFrame: baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks)
measure: Change in urinary bisphenol levels
timeFrame: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)
measure: Change in urinary phthalate levels
timeFrame: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)
measure: Change in gut microbiome composition
timeFrame: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)
Other outcomes:
Locations:
city: Washington
country: United States
facility: Milken Institute School of Public Health, George Washington University
state: District of Columbia
Study officials:
affiliation: Milken Institute School of Public Health, George Washington University
name: Kim Robien, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: