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

George Washington University (GW)

Status: Withdrawn

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

Treatments: Other: fecal sample (optional); Other: Patient-reported outcomes survey; Other: 24-hour dietary recall; Other: urine sample (optional); Other: Pittsburgh Sleep Quality Index; Other: Functional Assessment of Cancer Treatment - Lymphoma; Other: Hand grip strength; Other: International Physical Activity Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT04293900

180373

Details and patient eligibility

About

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 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Study cohort

Description:

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)

Treatment:

Other: International Physical Activity Questionnaire

Other: fecal sample (optional)

Other: Functional Assessment of Cancer Treatment - Lymphoma

Other: Pittsburgh Sleep Quality Index

Other: 24-hour dietary recall

Other: Patient-reported outcomes survey

Other: urine sample (optional)

Other: Hand grip strength