Ketogenic Diet Improves Thrombocytopenia in Cancer Patients

Sponsor
Baoling Guo (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06106139
Collaborator
(none)
80
4
17.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Strict ketogenic diet group
  • Dietary Supplement: Cyclic ketogenic diet group
  • Dietary Supplement: Autonomous ketogenesis group
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Ketogenic Diet in Preventing or Improving Thrombocytopenia in Cancer Patients Undergoing Chemotherapy: a Randomized Controlled Single Blind Study
Anticipated Study Start Date :
Dec 12, 2023
Anticipated Primary Completion Date :
Jun 10, 2024
Anticipated Study Completion Date :
Jun 10, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. thrombocytopenia [During radiotherapy and chemotherapy, approximately 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Baoling Guo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Baoling Guo, associate chief physician, Fujian Medical University
ClinicalTrials.gov Identifier:
NCT06106139
Other Study ID Numbers:
  • LYSY20230510
First Posted:
Oct 30, 2023
Last Update Posted:
Oct 30, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 30, 2023