Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

All Drugs and Chemicals

Bisphenol A

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)

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.

24-hour dietary recall

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.

Hand grip strength

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.

International Physical Activity Questionnaire

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.

Patient-reported outcomes survey

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.

Pittsburgh Sleep Quality Index

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.

Functional Assessment of Cancer Treatment - Lymphoma

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.

urine 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.

fecal sample (optional)

Kim Robien, PhD, RD

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).

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.

urine, fecal samples (optional component of the study)

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

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

Will not share data until study is complete and all data deidentified

change in kilograms of lean body mass as measured from staging CT-scans from pre- to post-R-CHOP chemotherapy.

change in adipose tissue volume (cm\^3) as measured from staging CT-scans from pre- to post-R-CHOP chemotherapy.

Change in total energy intake (kcal/day) from pre- to post-R-CHOP chemotherapy.

Change in dietary protein intake (g/day) from pre- to post-R-CHOP chemotherapy measured by diet history.

Change in daily metabolic equivalents (MET) of physical activity as measured by accelerometer from pre- to post-R-CHOP chemotherapy.

percent of change in urinary bisphenol levels (ng/mL) as measured by liquid chromotography-tandem mass spectrometry from pre- to post-R-CHOP chemotherapy

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 species and type of gut microbiota from pre- to post-R-CHOP chemotherapy

George Washington University

Associate Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Doxorubicin

Liposomal doxorubicin

Collect three urine samples either in the clinic or at home. This will occur prior to starting neoadjuvant chemotherapy, and again at the end of the scheduled course of neoadjuvant chemotherapy.

urine collection

In this observational pilot study urine samples will be collected from women receiving neoadjuvant chemotherapy with doxorubicin for triple negative breast cancer to determine whether: 1) exposures bisphenol and phthalate levels change over the course of neoadjuvant chemotherapy, and 2) levels differ between black women and those of other racial groups.

The hypothesis is that bisphenol and phthalate levels will be similar to those of the general US female population at the time of diagnosis, however levels will increase during treatment due to exposure to plastics in the medical setting. The investigators also hypothesize that because of differences in personal care product use, black women may have higher urinary levels of bisphenols and phthalates prior to starting chemotherapy.

Triple-negative breast cancer (TNBC) is an aggressive breast cancer subtype that does not express estrogen, progesterone, or the human epidermal growth factor (HER2/neu) receptors, and has a low overall survival rate compared to other types of breast cancer.

Unlike hormone and HER2/neu positive breast cancers, targeted therapies are not available for TNBC. Thus, the systemic chemotherapeutic agent doxorubicin is widely used for the treatment of TNBC. However, doxorubicin resistance is common, and leads to poorer treatment outcomes.

Understanding factors that contribute to doxorubicin resistance is critical to improving cancer treatment outcomes among women with TNBC. Pre-clinical in vitro studies indicate that exposure to endocrine disrupting chemicals, such as bisphenols and phthalates, contribute to doxorubicin resistance, but these findings have not been evaluated in humans.

Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer

Bisphenol and Phthalate Exposures in Women With Triple Negative Breast Cancer Receiving Doxorubicin Chemotherapy - a Pilot Study

quantification of bisphenol and phthalate metabolites by liquid chromotography-tandem mass spectrometry

percent of change in urinary bisphenol and phthalate levels from pre- to post-neoadjuvant chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Diet, Physical Activity and Body Composition Changes During R-CHOP	NCT04293900	Non-Hodgkin Lym... DLBCL Diffuse Large B...	24-hour dietary... Hand grip stren... International P... Patient-reporte... Pittsburgh Slee... Functional Asse... urine sample (o... fecal sample (o...	18 Years -	George Washington University
Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer	NCT04268693	Triple Negative...	urine collectio...	21 Years -	George Washington University

Spots Global Cancer Trial Database for phthalate

Every month we try and update this database with for phthalate cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for phthalate

Every month we try and update this database with for phthalate cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for phthalate cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.