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NCT03535701 · ClinicalTrials.gov registry record · Phase 1
Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer
A Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT03535701 is a Phase 1 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 20 participants.
The verdict
NCT03535701, a Phase 1 study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This pilot clinical trial studies how well a ketogenic diet and chemotherapy work in affecting the return of cancer in patients with stage IV breast cancer. Ketogenic diet may be more effective than standard nutrition and may affect quality of life, inflammation, and tumor-related changes. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ketogenic diet and chemotherapy may be better in patients with breast cancer.
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- OTHER Questionnaire Administration
- DIETARY_SUPPLEMENT Dietary Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-10-20 |
| Est. Completion | 2020-05-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03535701
The ClinicalTrials.gov registry entry for NCT03535701 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University Comprehensive Cancer Center, which has 341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03535701 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03535701 about?
NCT03535701 is a clinical study titled "Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer". This pilot clinical trial studies how well a ketogenic diet and chemotherapy work in affecting the return of cancer in patients with stage IV breast cancer. Ketogenic diet may be more effective than standard nutrition and may affect quality of life, inflammation, and tumor-related changes. Drugs use...
What is the current status of trial NCT03535701?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2017-10-20. Estimated completion is 2020-05-01.
What interventions are being tested in trial NCT03535701?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Questionnaire Administration (OTHER), Dietary Intervention (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03535701?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
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