Diet, Hepcidin, and Chemotherapy RDI

NCT06483997 | Active Not Recruiting

• 1 other identifier: NCR245680
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female; Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; Endometrial Cancer; Gynecologic Cancer

Keywords

nutrition; inflammation; anemia; toxicity; chemotoxicity

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Hematologic toxicity

  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

  at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)

• Treatment change or discontinuation

  at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)

• Blood transfusion

  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

  at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University Cancer Center

Washington D.C., District of Columbia, 20052, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Frozen serum

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Endometrial Neoplasms; Inflammation; Anemia

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Uterine Neoplasms; Uterine Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kim Robien, PhD, RD

  Milken Institute School of Public Health, George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 3, 2024
• Study Start: August 16, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)