Clinical trial · Observational
Diet, Hepcidin, and Chemotherapy RDI
Associations Between Diet, Hepcidin, and Relative Dose Intensity Among Women Receiving Chemotherapy for Breast or Gynecological Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Serum hepcidin concentration
- timeFrame
- pre-chemotherapy, single measure
- description
- ng/ml, continuous
- measure
- Chemotherapy relative dose intensity
- timeFrame
- during chemotherapy (up to 6 months, depends on duration of chemotherapy regimen), represents repeated measures
- description
- 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 outcomes (5)
- 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)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available