Diet, Physical Activity and Body Composition Changes During R-CHOP
- Conditions
- DLBCLNon-Hodgkin LymphomaDiffuse Large B Cell Lymphoma
- Interventions
- Other: 24-hour dietary recallOther: Hand grip strengthOther: International Physical Activity QuestionnaireOther: Patient-reported outcomes surveyOther: Pittsburgh Sleep Quality IndexOther: Functional Assessment of Cancer Treatment - LymphomaOther: urine sample (optional)Other: fecal sample (optional)
- Registration Number
- NCT04293900
- Lead Sponsor
- 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).
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Diagnosis of one of the non-Hodgkin lymphomas
- Scheduled to receive R-CHOP at the George Washington University Cancer Center
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study cohort International Physical Activity Questionnaire 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) Study cohort Hand grip strength 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) Study cohort Patient-reported outcomes survey 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) Study cohort Pittsburgh Sleep Quality Index 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) Study cohort 24-hour dietary recall 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) Study cohort Functional Assessment of Cancer Treatment - Lymphoma 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) Study cohort urine sample (optional) 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) Study cohort fecal sample (optional) 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)
- Primary Outcome Measures
Name Time Method Change in lean body mass (LBM) from baseline to end of R-CHOP chemotherapy 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
Name Time Method Change in urinary phthalate levels 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 adipose tissue volume from baseline to end of R-CHOP chemotherapy 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 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 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 daily metabolic equivalents (MET) of physical activity as measured by accelerometer from pre- to post-R-CHOP chemotherapy.
Change in gut microbiome composition 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
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 dietary protein intake (g/day) from pre- to post-R-CHOP chemotherapy measured by diet history.
Change in urinary bisphenol levels 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
Trial Locations
- Locations (1)
Milken Institute School of Public Health, George Washington University
🇺🇸Washington, District of Columbia, United States