Ketogenic Diet Improves Thrombocytopenia in Cancer Patients

Ketogenic Diet Clinical Trial

Official title:

The Effectiveness of Ketogenic Diet in Preventing or Improving Thrombocytopenia in Cancer Patients Undergoing Chemotherapy: a Randomized Controlled Single Blind Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06106139
• Other study ID #: LYSY20230510
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: May 12, 2024
• Est. completion date: June 10, 2025

Study information

• Verified date: March 2024
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate whether dietary intervention through ketogenic diet can prevent or improve chemotherapy related thrombocytopenia in cancer patients.

Description:

In the study, 80 patients with malignant solid tumors undergoing chemotherapy were randomly assigned to the normal diet group, the strict ketogenic diet group, the circulating ketogenic diet group, and the autonomous ketogenic group. During the chemotherapy period, the corresponding dietary intervention was carried out, and the clinical data of patients before and after treatment were collected, including blood routine, blood ketone concentration, weight, blood sugar, blood lipids, adverse events, and changes in platelets before and after chemotherapy, Statistical analysis of data such as the change degree of platelets and the incidence of adverse events in each diet group before and after treatment was carried out to evaluate the impact of ketogenic diet on clinical indicators and adverse reactions of chemotherapy in cancer patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 10, 2025
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Between the ages of 18 and 90, regardless of gender
• ECOG score = 2 points
• Received or expected to receive radiotherapy and chemotherapy during tumor activity
• Body mass index 19-29
• Conscious and autonomous eaters

Exclusion Criteria:

• Patients with basic diseases of diabetes
• Complications such as severe liver and kidney dysfunction or digestive tract obstruction, inability to eat
• Those who have a preference for food and have strict requirements for dietary taste
• Disagree to sign informed consent
• Those whose physical conditions are determined by the doctor to be impermissible

Related Conditions & MeSH terms

• Ketogenic Diet
• Thrombocytopenia

Intervention

Dietary Supplement:
• Strict ketogenic diet group
the patients ate ketogenic biscuits or ketogenic foods provided by the researchers every day. During the study, the patients were not allowed to drink any drinks or eat other foods except drinking water, so as to ensure that the daily intake of calories was roughly the same as that of the normal diet group.
• Cyclic ketogenic diet group
the patients took 7 days as a cycle, and 7 days of strict ketogenic diet+7 days of normal diet as a cycle. During the strict ketogenic diet, the patient should eat the ketogenic biscuit or ketogenic food provided by the researcher every day, and should not drink any beverage or eat other food except drinking water; During the normal diet period, patients followed the "Dietary Guidelines for Chinese Residents (2022)" to ensure nutritional balance. During the study period, patients were guaranteed to eat approximately the same amount of calories per day as the normal diet group.
• Autonomous ketogenesis group
Patients choose ingredients for cooking and consumption under the guidance of researchers, ensuring that the nutritional composition is about 90% fat, 10% protein, and can contain a small amount of carbohydrates (10%). The daily calorie intake is around 1600~2400 kcal.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baoling Guo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thrombocytopenia		During radiotherapy and chemotherapy, approximately 3 months