Breast Cancer Female, Endometrial Cancer, Fallopian Tube Cancer, Gynecologic Cancer, Ovarian Cancer, Primary Peritoneal Carcinoma
Conditions
Keywords
nutrition, inflammation, anemia, toxicity, chemotoxicity
Brief summary
This prospective, observational cohort study will evaluate the extent of associations between self-reported pro- or anti- inflammatory dietary intake patterns for one month before induction chemotherapy for gynecological cancer or neo/adjuvant chemotherapy for breast cancer and baseline serum hepcidin concentrations. Associations between hepcidin concentration and relative dose intensity (RDI) of chemotherapy will also be evaluated.
Detailed description
This is a prospective, observational cohort of 100 women receiving chemotherapy for breast or gynecological cancer at GW Cancer Center from July 1, 2024 - approximately September 2025. At study baseline (after diagnosis, but prior to starting chemotherapy), participants will complete a \ 30-minute food frequency questionnaire (FFQ) and demographic/food security survey using a preprogrammed iPad in the clinic. The clinical research nurse will obtain an additional research blood draw at the same time as the patient's routine clinical blood draw prior to chemotherapy initiation for serum hepcidin concentration measurement. Data on cancer type, premorbid medical conditions, and chemotherapy plans and administration will be collected from the electronic health record by study staff and the duration of data collection will be the length of chemotherapy plus 30 days. Data will be used to address the objectives below. Among adult women scheduled to receive chemotherapy for breast or gynecological cancer treatment, the objectives/aims of this study will be to: 1. Determine the extent to which pretreatment, self-reported Dietary Inflammatory Index dietary pattern scores from dietary intake during the one month prior to chemotherapy initiation are associated with pretreatment serum hepcidin concentrations 2. Determine the extent to which pretreatment serum hepcidin concentrations are associated with chemotherapy RDI.
Interventions
None listed
Sponsors
George Washington University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have been diagnosed with invasive breast cancer, OR * Have been diagnosed with epithelial ovarian cancer, fallopian tube or primary peritoneal cancer, OR * Have been diagnosed with endometrial cancer * Are chemotherapy-naïve * Are scheduled to receive neoadjuvant chemotherapy (or adjuvant chemotherapy following lumpectomy for breast cancer patients) or neoadjuvant/induction chemotherapy for gynecological cancer at GW Cancer Center
Exclusion criteria
* Prior primary hematological condition that would cause abnormal blood counts (e.g. leukemia) * Pregnant at the time of potential enrollment * Receipt of erythropoietin-stimulating agents or blood transfusion in the 6 weeks prior to initial testing * Women who are cognitively unable to provide a diet history for the month prior to assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum hepcidin concentration | pre-chemotherapy, single measure | ng/ml, continuous |
| Chemotherapy relative dose intensity | during chemotherapy (up to 6 months, depends on duration of chemotherapy regimen), represents repeated measures | Calculated variable that represents the ratio of chemotherapy actually received during the duration of treatment to the planned chemotherapy dose during the planned duration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematologic toxicity | at any point during chemotherapy or within 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen) | Incidence of CTCAE grade 3 or higher hematologic toxicity (anemia, neutropenia, thrombocytopenia) |
| Treatment delays | at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen) | Delay of chemotherapy due to chemo-related adverse events, including hematologic toxicity, infection, hospitalization, or severe symptoms |
| Treatment change or discontinuation | at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen) | Change of chemotherapy regimen or discontinuation of treatment due to chemo-related adverse events, including hematologic toxicity, infection, hospitalization, or severe symptoms |
| Blood transfusion | at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen) | Infusion of red blood cells, platelets, fresh frozen plasma, or other donated human blood products due to chemo-related hematologic toxicity |
| Hospitalizations | at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen) | Unscheduled admission to a hospital or similar medical facility due to due to chemo-related adverse events, including hematologic toxicity, infection, or severe symptoms |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKim Robien, PhD, RD
Milken Institute School of Public Health, George Washington University
Outcome results
None listed