ACTIVE_NOT_RECRUITING

Diet, Hepcidin, and Chemotherapy RDI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Associations Between Diet, Hepcidin, and Relative Dose Intensity Among Women Receiving Chemotherapy for Breast or Gynecological Cancer

Quick Facts

Study Start:2024-08-16
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06483997

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have been diagnosed with invasive breast cancer, OR
  2. * Have been diagnosed with epithelial ovarian cancer, fallopian tube or primary peritoneal cancer, OR
  3. * Have been diagnosed with endometrial cancer
  4. * Are chemotherapy-naïve
  5. * 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
  1. * Prior primary hematological condition that would cause abnormal blood counts (e.g. leukemia)
  2. * Pregnant at the time of potential enrollment
  3. * Receipt of erythropoietin-stimulating agents or blood transfusion in the 6 weeks prior to initial testing
  4. * Women who are cognitively unable to provide a diet history for the month prior to assessment.

Contacts and Locations

Principal Investigator

Kim Robien, PhD, RD
PRINCIPAL_INVESTIGATOR
Milken Institute School of Public Health, George Washington University

Study Locations (Sites)

George Washington University Cancer Center
Washington D.C., District of Columbia, 20052
United States

Collaborators and Investigators

Sponsor: George Washington University

  • Kim Robien, PhD, RD, PRINCIPAL_INVESTIGATOR, Milken Institute School of Public Health, George Washington University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-16
Study Completion Date2026-07

Study Record Updates

Study Start Date2024-08-16
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • nutrition
  • inflammation
  • anemia
  • toxicity
  • chemotoxicity

Additional Relevant MeSH Terms

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