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

Non-Hodgkin Lymphoma Clinical Trial

— R-CHOP-OS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04293900
• Other study ID #: 180373
• Status: Withdrawn
• Start date: January 2021
• Est. completion date: December 2023

Study information

• Verified date: October 2020
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Milken Institute School of Public Health, George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)