Diet, Hepcidin, and Chemotherapy RDI (NCT06483997) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Diet, Hepcidin, and Chemotherapy RDI
United States100 participantsStarted 2024-08-16
Plain-language 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.
Who can participate
Age range
21 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serum hepcidin concentration
Timeframe: pre-chemotherapy, single measure
2
Chemotherapy relative dose intensity
Timeframe: during chemotherapy (up to 6 months, depends on duration of chemotherapy regimen), represents repeated measures