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

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Non-Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma; DLBCL
• Intervention / Treatment: 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)

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20052
      • Milken Institute School of Public Health, George Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study cohort; 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; 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.; Other: Hand grip strength; 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.; Other: International Physical Activity Questionnaire; 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.; Other Names: IPAQ; Other: Patient-reported outcomes survey; 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.; Other Names: NCI-PRO-CTCAE; Other: Pittsburgh Sleep Quality Index; 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.; Other Names: PSQI; Other: Functional Assessment of Cancer Treatment - Lymphoma; 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.; Other Names: FACT-lym; Other: urine sample (optional); 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.; Other: fecal sample (optional); 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: George Washington University
• Investigators: Principal Investigator: Kim Robien, PhD, RD, Milken Institute School of Public Health, George Washington University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: physical activity; body composition; gut microbiome; diet; bisphenol; phthalate
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: 180373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Will not share data until study is complete and all data deidentified

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No