Breast Cancer FemaleNCT06483997
Diet, Hepcidin, and Chemotherapy RDI
An observational study of Breast Cancer Female and Ovarian Cancer, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Ovarian Cancer, Fallopian Tube Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2024to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 100 women receiving chemotherapy for breast or gynecological cancer at GW Cancer Center from July, 2024 - July, 2026
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Cancer Center
Washington D.C., District of Columbia, 20052
About this study
Official title: Associations Between Diet, Hepcidin, and Relative Dose Intensity Among Women Receiving Chemotherapy for Breast or Gynecological Cancer
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.
Read the detailed description
This is a prospective, observational cohort of 100 women receiving chemotherapy for breast or gynecological cancer at GW Cancer Center from July 1, 2024 - approximately September 2025. At study baseline (after diagnosis, but prior to starting chemotherapy), participants will complete a ~30-minute food frequency questionnaire (FFQ) and demographic/food security survey using a preprogrammed iPad in the clinic. The clinical research nurse will obtain an additional research blood draw at the same time as the patient's routine clinical blood draw prior to chemotherapy initiation for serum hepcidin concentration measurement. Data on cancer type, premorbid medical conditions, and chemotherapy plans and administration will be collected from the electronic health record by study staff and the duration of data collection will be the length of chemotherapy plus 30 days. Data will be used to address the objectives below.
Among adult women scheduled to receive chemotherapy for breast or gynecological cancer treatment, the objectives/aims of this study will be to:
- Determine the extent to which pretreatment, self-reported Dietary Inflammatory Index dietary pattern scores from dietary intake during the one month prior to chemotherapy initiation are associated with pretreatment serum hepcidin concentrations
- Determine the extent to which pretreatment serum hepcidin concentrations are associated with chemotherapy RDI.
- Conditions
- Breast Cancer Female, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Endometrial Cancer, Gynecologic Cancer
- Keywords
- nutrition, inflammation, anemia, toxicity, chemotoxicity
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Endometrial Neoplasms, Inflammation, Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum hepcidin concentration
ng/ml, continuous
Measured: 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
Measured: during chemotherapy (up to 6 months, depends on duration of chemotherapy regimen), represents repeated measures
Secondary outcomes (5)
Hematologic toxicity
Incidence of CTCAE grade 3 or higher hematologic toxicity (anemia, neutropenia, thrombocytopenia)
Measured: 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
Delay of chemotherapy due to chemo-related adverse events, including hematologic toxicity, infection, hospitalization, or severe symptoms
Measured: at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Treatment change or discontinuation
Change of chemotherapy regimen or discontinuation of treatment due to chemo-related adverse events, including hematologic toxicity, infection, hospitalization, or severe symptoms
Measured: at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Blood transfusion
Infusion of red blood cells, platelets, fresh frozen plasma, or other donated human blood products due to chemo-related hematologic toxicity
Measured: 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
Unscheduled admission to a hospital or similar medical facility due to due to chemo-related adverse events, including hematologic toxicity, infection, or severe symptoms
Measured: at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start16 Aug 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Robien, George Washington University
- Investigators
- Kim Robien, PhD, RD, Principal investigator, Milken Institute School of Public Health, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483997
- Sponsor's protocol ID
- NCR245680
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Qualified researchers may contact the PI with proposals to collaborate on secondary analyses using the study data. To protect participants privacy and data security, no individual patient data will be made available to external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Diet, Hepcidin, and Relative Dose Intensity Among Women Receiving Chemotherapy for Breast or Gynecological Cancer
- ClinicalTrials.gov ID
- NCT06483997
- Acronym / sponsor ID
- NCR245680
- Conditions
- Breast Cancer Female, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Endometrial Cancer, Gynecologic Cancer
- Keywords
- nutrition, inflammation, anemia, toxicity, chemotoxicity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, observational cohort of 100 women receiving chemotherapy for breast or gynecological cancer at GW Cancer Center from July 1, 2024 - approximately September 2025. At study baseline (after diagnosis, but prior to starting chemotherapy), participants will complete a ~30-minute food frequency questionnaire (FFQ) and demographic/food security survey using a preprogrammed iPad in the clinic. The clinical research nurse will obtain an additional research blood draw at the same time as the patient's routine clinical blood draw prior to chemotherapy initiation for serum hepcidin concentration measurement. Data on cancer type, premorbid medical conditions, and chemotherapy plans and administration will be collected from the electronic health record by study staff and the duration of data collection will be the length of chemotherapy plus 30 days. Data will be used to address the objectives below.
Among adult women scheduled to receive chemotherapy for breast or gynecological cancer treatment, the objectives/aims of this study will be to:
- Determine the extent to which pretreatment, self-reported Dietary Inflammatory Index dietary pattern scores from dietary intake during the one month prior to chemotherapy initiation are associated with pretreatment serum hepcidin concentrations
- Determine the extent to which pretreatment serum hepcidin concentrations are associated with chemotherapy RDI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 women receiving chemotherapy for breast or gynecological cancer at GW Cancer Center from July, 2024 - July, 2026
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum hepcidin concentration
Time frame: pre-chemotherapy, single measure
ng/ml, continuous
Chemotherapy relative dose intensity
Time frame: during chemotherapy (up to 6 months, depends on duration of chemotherapy regimen), represents repeated measures
Calculated variable that represents the ratio of chemotherapy actually received during the duration of treatment to the planned chemotherapy dose during the planned duration
5 secondary outcomes
Hematologic toxicity
Time frame: 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
Time frame: at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Treatment change or discontinuation
Time frame: at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Blood transfusion
Time frame: 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
Time frame: at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. Qualified researchers may contact the PI with proposals to collaborate on secondary analyses using the study data. To protect participants privacy and data security, no individual patient data will be made available to external researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Robien, PhD, RD principal investigator
Milken Institute School of Public Health, George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Ovarian Cancer, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum hepcidin concentration (time frame: pre-chemotherapy, single measure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.