Diet, Physical Activity and Body Composition Changes During R-CHOP

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Observational Study of Diet, Physical Activity and Body Composition Changes During R-CHOP Treatment for NHL

Conditions
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Non-Hodgkin Lymphoma, DLBCL, Diffuse Large B Cell Lymphoma

Intervention / Treatment
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* Other: 24-hour dietary recall
* Other: Hand grip strength
* Other: International Physical Activity Questionnaire
* Other: Patient-reported outcomes survey
* Other: Pittsburgh Sleep Quality Index
* Other: Functional Assessment of Cancer Treatment - Lymphoma
* Other: urine sample (optional)
* Other: fecal sample (optional)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study cohort<br>24-hour dietary recall, hand grip strength, accelerometer, International Physical Activity Questionnaire (IPAQ), Patient-reported outcomes survey (NCI-PRO-CTCAE), Pittsburgh Sleep Quality Index (PSQI), Functional Assessment of Cancer Treatment - Lymphoma (FACT-lym), urine sample (optional), fecal sample (optional) | Other: 24-hour dietary recall<br>* 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.<br>Other: Hand grip strength<br>* 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.<br>Other: International Physical Activity Questionnaire<br>* 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.<br>* Other names: IPAQ;Other: Patient-reported outcomes survey<br>* 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.<br>* Other names: NCI-PRO-CTCAE;Other: Pittsburgh Sleep Quality Index<br>* 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.<br>* Other names: PSQI;Other: Functional Assessment of Cancer Treatment - Lymphoma<br>* 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.<br>* Other names: FACT-lym;Other: urine sample (optional)<br>* 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.<br>Other: fecal sample (optional)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and post-R-CHOP chemotherapy (18 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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 | 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 | 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 | baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, physical activity, body composition, bisphenol, phthalate, gut microbiome