Clinical trial NCT06483997: Diet, Hepcidin, and Chemotherapy RDI
Official title: Associations Between Diet, Hepcidin, and Relative Dose Intensity Among Women Receiving Chemotherapy for Breast or Gynecological Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Female
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Endometrial Cancer
Gynecologic Cancer
Keywords: nutrition
inflammation
anemia
toxicity
chemotoxicity
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 women receiving chemotherapy for breast or gynecological cancer at GW Cancer Center from July, 2024 - July, 2026

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum hepcidin concentration
timeFrame: pre-chemotherapy, single measure
measure: Chemotherapy relative dose intensity
timeFrame: during chemotherapy (up to 6 months, depends on duration of chemotherapy regimen), represents repeated measures
Secondary outcomes:
measure: Hematologic toxicity
timeFrame: at any point during chemotherapy or within 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
measure: Treatment delays
timeFrame: at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
measure: Treatment change or discontinuation
timeFrame: at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
measure: Blood transfusion
timeFrame: at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
measure: Hospitalizations
timeFrame: at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Cancer Center
state: District of Columbia
Study officials:
affiliation: Milken Institute School of Public Health, George Washington University
name: Kim Robien, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: