Ketogenic Diet Improves Thrombocytopenia in Cancer Patients

NCT06106139 | Not Yet Recruiting Phase 1

• 1 other identifier: LYSY20230510
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ketogenic Diet

Outcome Measures

Primary Outcomes (1)

• thrombocytopenia

  During radiotherapy and chemotherapy, approximately 3 months

Study Arms (4)

Normal diet group

NO INTERVENTION

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.

Strict ketogenic diet group

EXPERIMENTAL

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

Cyclic ketogenic diet group

EXPERIMENTAL

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

Autonomous ketogenesis group

EXPERIMENTAL

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

Interventions

Strict ketogenic diet group 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.

Strict ketogenic diet group

Cyclic ketogenic diet group 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.

Cyclic ketogenic diet group

Autonomous ketogenesis group 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.

Autonomous ketogenesis group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baoling Guo: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: October 30, 2023
• Study Start: May 12, 2024
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-03