Clinical trial · Interventional
Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer
Ketogenic Diet and Chemotherapy to Affect Recurrence of Breast Cancer (The KETO-CARE Study)
- 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 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary Intervention | Dietary Supplement | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (standard of care)
- description
- Patients receive standard of care therapy with paclitaxel.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Drug: Paclitaxel
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Arm II (standard of care, ketogenic diet)
- description
- Patients receive standard of care with paclitaxel. Patients undergo a controlled feeding period ketogenic diet comprising of meals prepared in the research kitchen for 3 months. Beginning 2 weeks prior to completion of the controlled feeding period, patients also undergo free living ketogenic diet program for 3 months comprising of group format, individual sessions, and online digital content to educate patients to implement a ketogenic eating pattern into their lifestyle.
- interventionNames
- Dietary Supplement: Dietary Intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Body mass index (BMI) \>= 22 kg/m\^2 * Confirmed diagnosis of metastatic or stage IV BC * Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET) avid tumors * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (0=participant has either normal activity, 1= participant has some symptoms but is nearly full ambulatory) * Life expectancy \> 6 months * Able and willing to follow prescribed diet intervention Exclusion Criteria: * Prior chemotherapy for metastatic breast cancer (MBC) (prior adjuvant chemotherapy permitted as long as \> 12 months \[mo\]) * BMI \< 25 kg/m\^2 * Weight change \> 5% within 3 months of enrollment * Type 1 diabetes * History of diabetes with retinopathy requiring treatment * Current use of insulin or sulfonylureads for glycemic control, or history of ketoacidosis * Intestinal obstruction * Bilirubin \> 2 * Albumin \< 3.5 * Glomerular filtration rate (GFR) \< 55 mL/min * Creatinine \> 2.0 * Urinary albumin \> 1 g/day * Congestive heart failure * Pregnant or nursing women * Unable to provide informed consent * Uncontrolled concurrent medical conditions that would limit compliance with study requirements
References
Publications (1)
- DERIVEDBuga A, Harper DG, Sapper TN, Hyde PN, Fell B, Dickerson R, Stoner JT, Kackley ML, Crabtree CD, Decker DD, Robinson BT, Krystal G, Binzel K, Lustberg MB, Volek JS. Feasibility and metabolic outcomes of a well-formulated ketogenic diet as an adjuvant therapeutic intervention for women with stage IV metastatic breast cancer: The Keto-CARE trial. PLoS One. 2024 Jan 2;19(1):e0296523. doi: 10.1371/journal.pone.0296523. eCollection 2024. PMID 38166036