Evaluating diet and hepcidin levels in women undergoing chemotherapy for cancer
Associations Between Diet, Hepcidin, and Relative Dose Intensity Among Women Receiving Chemotherapy for Breast or Gynecological Cancer
This study is testing how diet affects hepcidin levels in women with breast or gynecological cancers before they start chemotherapy to see if it impacts their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | George Washington University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Washington, District of Columbia) |
| Trial ID | NCT06483997 on ClinicalTrials.gov |
What this trial studies
This observational cohort study will assess the relationship between dietary intake patterns and serum hepcidin concentrations in women diagnosed with breast or gynecological cancers prior to starting chemotherapy. Participants will complete a food frequency questionnaire and undergo blood draws to measure hepcidin levels. The study aims to explore how these factors may influence the relative dose intensity of chemotherapy. Data will be collected over the duration of chemotherapy treatment and for 30 days afterward.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with invasive breast cancer or specific gynecological cancers who are chemotherapy-naïve and scheduled to receive chemotherapy.
Not a fit: Patients with prior hematological conditions, those who are pregnant, or those unable to provide dietary history may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help optimize chemotherapy dosing and improve treatment outcomes for women with breast and gynecological cancers.
How similar studies have performed: While there is ongoing research into the impact of diet on cancer treatment, this specific approach of linking dietary patterns with hepcidin levels and chemotherapy dosing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Washington, District of Columbia
- George Washington University Cancer Center — Washington, District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Kim Robien, PhD, RD — Milken Institute School of Public Health, George Washington University
- Study coordinator: Kim Robien, PhD, RD
- Email: krobien@gwu.edu
- Phone: 202-994-2574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.