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

NCT04293900 | Withdrawn

• 1 other identifier: 180373
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-Hodgkin Lymphoma; DLBCL; Diffuse Large B Cell Lymphoma

Keywords

diet; physical activity; body composition; bisphenol; phthalate; gut microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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 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 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 urinary bisphenol levels

  baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)

Study Arms (1)

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; 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)

Interventions

24-hour dietary recall OTHER

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.

Study cohort

Hand grip strength OTHER

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.

Study cohort

International Physical Activity Questionnaire OTHER

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.

Also known as: IPAQ

Study cohort

Patient-reported outcomes survey OTHER

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.

Also known as: NCI-PRO-CTCAE

Study cohort

Pittsburgh Sleep Quality Index OTHER

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.

Also known as: PSQI

Study cohort

Functional Assessment of Cancer Treatment - Lymphoma OTHER

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.

Also known as: FACT-lym

Study cohort

urine sample (optional) OTHER

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.

Study cohort

fecal sample (optional) OTHER

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.

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Diagnosis of one of the non-Hodgkin lymphomas
• Scheduled to receive R-CHOP at the George Washington University Cancer Center

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

Milken Institute School of Public Health, George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine, fecal samples (optional component of the study)

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Motor Activity

Interventions

Hand Strength

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Behavior

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kim Robien, PhD, RD

  Milken Institute School of Public Health, George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: March 3, 2020
• Study Start: January 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)