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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.
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:
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| Measure | Description | Time Frame |
|---|---|---|
| Serum hepcidin concentration | ng/ml, continuous | pre-chemotherapy, single measure |
| Chemotherapy relative dose intensity | Calculated variable that represents the ratio of chemotherapy actually received during the duration of treatment to the planned chemotherapy dose during the planned duration | during chemotherapy (up to 6 months, depends on duration of chemotherapy regimen), represents repeated measures |
| Measure | Description | Time Frame |
|---|---|---|
| Hematologic toxicity | Incidence of CTCAE grade 3 or higher hematologic toxicity (anemia, neutropenia, thrombocytopenia) | at any point during chemotherapy or within 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen) |
| Treatment delays |
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Inclusion Criteria:
Exclusion Criteria:
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100 women receiving chemotherapy for breast or gynecological cancer at GW Cancer Center from July, 2024 - July, 2026
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| Name | Affiliation | Role |
|---|---|---|
| Kim Robien, PhD, RD | Milken Institute School of Public Health, George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University Cancer Center | Washington D.C. | District of Columbia | 20052 | United States |
Qualified researchers may contact the PI with proposals to collaborate on secondary analyses using the study data. To protect participants privacy and data security, no individual patient data will be made available to external researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2024 | Jun 28, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D016889 | Endometrial Neoplasms |
| D007249 | Inflammation |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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Frozen serum
Delay of chemotherapy due to chemo-related adverse events, including hematologic toxicity, infection, hospitalization, or severe symptoms |
| at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen) |
| Treatment change or discontinuation | Change of chemotherapy regimen or discontinuation of treatment due to chemo-related adverse events, including hematologic toxicity, infection, hospitalization, or severe symptoms | at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen) |
| Blood transfusion | Infusion of red blood cells, platelets, fresh frozen plasma, or other donated human blood products due to chemo-related hematologic toxicity | at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen) |
| Hospitalizations | Unscheduled admission to a hospital or similar medical facility due to due to chemo-related adverse events, including hematologic toxicity, infection, or severe symptoms | at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen) |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |