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

Overview

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).

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2022

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.

Interventions

  • 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: 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: 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: 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: 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.

Arms, Groups and Cohorts

  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Change in adipose tissue volume from baseline to end of R-CHOP chemotherapy
    • Time Frame: baseline and post-R-CHOP chemotherapy (18 weeks)
    • change in adipose tissue volume (cm^3) as measured from staging CT-scans from pre- to post-R-CHOP chemotherapy.
  • Change in dietary energy from baseline to end of R-CHOP chemotherapy
    • Time Frame: baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks)
    • Change in total energy intake (kcal/day) from pre- to post-R-CHOP chemotherapy.
  • Change in dietary protein intake from baseline to end of R-CHOP chemotherapy
    • Time Frame: baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks)
    • Change in dietary protein intake (g/day) from pre- to post-R-CHOP chemotherapy measured by diet history.
  • Change in physical activity level from baseline to end of R-CHOP chemotherapy
    • Time Frame: baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks)
    • Change in daily metabolic equivalents (MET) of physical activity as measured by accelerometer from pre- to post-R-CHOP chemotherapy.
  • Change in urinary bisphenol levels
    • Time Frame: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)
    • percent of change in urinary bisphenol levels (ng/mL) as measured by liquid chromotography-tandem mass spectrometry from pre- to post-R-CHOP chemotherapy
  • Change in urinary phthalate levels
    • Time Frame: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)
    • percent of change in urinary phthalate levels (ng/ML) as measured by liquid chromotography-tandem mass spectrometry from pre- to post-R-CHOP chemotherapy
  • Change in gut microbiome composition
    • Time Frame: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)
    • Change in species and type of gut microbiota from pre- to post-R-CHOP chemotherapy

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • George Washington University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kimberly Robien, Associate Professor – George Washington University
  • Overall Official(s)
    • Kim Robien, PhD, RD, Principal Investigator, Milken Institute School of Public Health, George Washington University
  • Overall Contact(s)
    • Kim Robien, PhD, RD, 202-994-2574, krobien@gwu.edu

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