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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04293900
Recruitment Status : Withdrawn (Study never started due to COVID pandemic and lack of study funding.)
First Posted : March 3, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Kimberly Robien, George Washington University

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).

Condition or disease Intervention/treatment
Non-Hodgkin Lymphoma DLBCL Diffuse Large B Cell Lymphoma 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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of Diet, Physical Activity and Body Composition Changes During R-CHOP Treatment for NHL
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023


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 Name: 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 Name: 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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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


Biospecimen Retention:   Samples Without DNA
urine, fecal samples (optional component of the study)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04293900


Locations
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United States, District of Columbia
Milken Institute School of Public Health, George Washington University
Washington, District of Columbia, United States, 20052
Sponsors and Collaborators
George Washington University
Investigators
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Principal Investigator: Kim Robien, PhD, RD Milken Institute School of Public Health, George Washington University
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Responsible Party: Kimberly Robien, Associate Professor, George Washington University
ClinicalTrials.gov Identifier: NCT04293900    
Other Study ID Numbers: 180373
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will not share data until study is complete and all data deidentified

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kimberly Robien, George Washington University:
diet
physical activity
body composition
bisphenol
phthalate
gut microbiome
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell