Ketogenic Diet Improves Thrombocytopenia in Cancer Patients

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ketogenic Diet
• Intervention / Treatment: Dietary supplement: Strict ketogenic diet group; Dietary supplement: Cyclic ketogenic diet group; Dietary supplement: Autonomous ketogenesis group

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Normal diet group; This group of patients follows the "Dietary Guidelines for Chinese Residents (2022)" to ensure balanced nutrition, with daily calorie intake ranging from 1600 to 2400 kcal.
Experimental: 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.	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.
Experimental: 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.	Dietary supplement: 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.
Experimental: 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.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
thrombocytopenia	During radiotherapy and chemotherapy, approximately 3 months

Collaborators and Investigators

• Sponsor: Baoling Guo

Study record dates

Study Major Dates

• Study Start (Estimated): May 12, 2024
• Primary Completion (Estimated): June 10, 2024
• Study Completion (Estimated): June 10, 2025

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: LYSY20230510

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No