Ketogenic Diet Improves Thrombocytopenia in Cancer Patients

NCT ID: NCT06106139

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-12
• Study Completion Date: 2025-06-10

Brief 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.

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.

Conditions

Ketogenic Diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Strict ketogenic diet group

Intervention Type: DIETARY_SUPPLEMENT

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.

Group Type: EXPERIMENTAL

Cyclic ketogenic diet group

Intervention Type: DIETARY_SUPPLEMENT

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.

Group Type: EXPERIMENTAL

Autonomous ketogenesis group

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baoling Guo

OTHER

Sponsor Role: lead

Responsible Party

Baoling Guo

associate chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

LYSY20230510

Identifier Type: -

Identifier Source: org_study_id