Non-Hodgkin LymphomaR-CHOP-OSNCT04293900
Diet, Physical Activity and Body Composition Changes During R-CHOP
An observational study of Non-Hodgkin Lymphoma and DLBCL, run by George Washington University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma, DLBCL, Diffuse Large B Cell Lymphoma
- What is being tested?
- 24-hour dietary recall, Hand grip strength and International Physical Activity Questionnaire
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2021to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being treated at the George Washington University for non-Hodgkin lymphoma who are scheduled to receive R-CHOP chemotherapy
Who may be able to join
- Diagnosis of one of the non-Hodgkin lymphomas
- Scheduled to receive R-CHOP at the George Washington University Cancer Center
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Milken Institute School of Public Health, George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: Prospective Observational Study of Diet, Physical Activity and Body Composition Changes During R-CHOP Treatment for NHL
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).
Read the 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.
- Conditions
- Non-Hodgkin Lymphoma, DLBCL, Diffuse Large B Cell Lymphoma
- Being tested
- 24-hour dietary recall, Hand grip strength, International Physical Activity Questionnaire, Patient-reported outcomes survey, Pittsburgh Sleep Quality Index
- Keywords
- diet, physical activity, body composition, bisphenol, phthalate, gut microbiome
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hour dietary recallOther
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 strengthOther
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 QuestionnaireOther
Also called IPAQ
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 surveyOther
Also called NCI-PRO-CTCAE
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 IndexOther
Also called PSQI
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 - LymphomaOther
Also called FACT-lym
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)Other
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and post-R-CHOP chemotherapy (18 weeks)
Secondary outcomes (7)
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.
Measured: baseline and post-R-CHOP chemotherapy (18 weeks)
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.
Measured: baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks)
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.
Measured: baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks)
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.
Measured: baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks)
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
Measured: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)
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
Measured: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)
Change in gut microbiome composition
Change in species and type of gut microbiota from pre- to post-R-CHOP chemotherapy
Measured: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study startJan 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Study never started due to COVID pandemic and lack of study funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Robien, George Washington University
- Investigators
- Kim Robien, PhD, RD, Principal investigator, Milken Institute School of Public Health, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293900
- Sponsor's protocol ID
- 180373
- Acronym
- R-CHOP-OS
- Status last verified
- Oct 2020
- First submitted
- 18 Feb 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not share data until study is complete and all data deidentified
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Diet, Physical Activity and Body Composition Changes During R-CHOP Treatment for NHL
- ClinicalTrials.gov ID
- NCT04293900
- Acronym / sponsor ID
- R-CHOP-OS / 180373
- Conditions
- Non-Hodgkin Lymphoma, DLBCL, Diffuse Large B Cell Lymphoma
- Keywords
- diet, physical activity, body composition, bisphenol, phthalate, gut microbiome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study never started due to COVID pandemic and lack of study funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | 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)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being treated at the George Washington University for non-Hodgkin lymphoma who are scheduled to receive R-CHOP chemotherapy
Key inclusion criteria (2 listed)
- Diagnosis of one of the non-Hodgkin lymphomas
- Scheduled to receive R-CHOP at the George Washington University Cancer Center
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-hour dietary recallDietary 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 | Study cohort |
| Hand grip strengthMeasurement 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 | Study cohort |
| International Physical Activity QuestionnaireAlso: IPAQSurvey 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 | Study cohort |
| Patient-reported outcomes surveyAlso: NCI-PRO-CTCAESurvey 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 | Study cohort |
| Pittsburgh Sleep Quality IndexAlso: PSQISurvey 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 | Study cohort |
| Functional Assessment of Cancer Treatment - LymphomaAlso: FACT-lymSurvey 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 | Study cohort |
| 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 | Study cohort |
| 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. | Other | Study cohort |
Primary outcome
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.
7 secondary outcomes
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 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 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 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 urinary bisphenol levels
Time frame: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)
Change in urinary phthalate levels
Time frame: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)
Change in gut microbiome composition
Time frame: baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Individual participant dataSharing planned: No. Will not share data until study is complete and all data deidentified
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Robien, PhD, RD principal investigator
Milken Institute School of Public Health, George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin Lymphoma and DLBCL, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lean body mass (LBM) from baseline to end of R-CHOP chemotherapy (time frame: baseline and post-R-CHOP chemotherapy (18 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.