The ketogenic diet effect in treatment of metastatic breast cancer

Assessment of the adjuvant ketogenic diet effect on the therapeutic outcomes of metastatic breast cancer patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210919052515N1

Enrollment

Registered

2021-10-22

Start date

2021-11-22

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer. Malignant neoplasm of breast

Interventions

Intervention 1: Intervention group: Patients will be received the ketogenic diet for three months in addition to the standard chemotherapy protocol. Manuals of this diet will be provided to patients.

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Metastatic breast cancer patients Age over 18 years

Exclusion criteria

Exclusion criteria: Lipid metabolism disorders such as carnitine deficiency Patients with liver failure Metastasis more than 50% of liver tissue History of gastric and pancreatic surgeries Renal cell carcinoma Type 1 diabetes

Design outcomes

Primary

Measure	Time frame
Primary tumor size and metastasis. Timepoint: Before and three months after the intervention. Method of measurement: With CT scan imaging in millimeters.	—

Secondary

Measure	Time frame
Ketone Bodies. Timepoint: Before and three months after the intervention. Method of measurement: Ketone meter in blood serum (mM/L).;Vascular endothelium growth factor expression (VEGF). Timepoint: Before and three months after the intervention. Method of measurement: Blood serum (Pg/mL).;C-Reactive Protein (CRP). Timepoint: Before and three months after the intervention. Method of measurement: Blood serum (mg/L).;Serum albumin. Timepoint: Before and three months after the intervention. Method of measurement: Blood serum sample (gr/dl).;Quality of life. Timepoint: Before and three months after the intervention. Method of measurement: Breast cancer-specific quality of life questionnaire (QLQ-BR 23).	—

Measure

Time frame

Ketone Bodies. Timepoint: Before and three months after the intervention. Method of measurement: Ketone meter in blood serum (mM/L).;Vascular endothelium growth factor expression (VEGF). Timepoint: Before and three months after the intervention. Method of measurement: Blood serum (Pg/mL).;C-Reactive Protein (CRP). Timepoint: Before and three months after the intervention. Method of measurement: Blood serum (mg/L).;Serum albumin. Timepoint: Before and three months after the intervention. Method of measurement: Blood serum sample (gr/dl).;Quality of life. Timepoint: Before and three months after the intervention. Method of measurement: Breast cancer-specific quality of life questionnaire (QLQ-BR 23).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Naser Masoudi

Oroumia University of Medical Sciences

dr.nasmasoudi@gmail.com+98 44 3337 9924

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026