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Trial record 6 of 11 for:    imdea food

Short-term Fasting as an Enhancer of Chemotherapy: Pilot Clinical Study on Colorectal Carcinoma Patients (CHEMOFAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04247464
Recruitment Status : Enrolling by invitation
First Posted : January 30, 2020
Last Update Posted : January 18, 2023
Sponsor:
Collaborators:
Hospital Infanta Sofia
Hospital Universitario La Paz
Information provided by (Responsible Party):
IMDEA Food

Brief Summary:
This study will evaluate the ability of short-term fasting to reduce chemotherapy toxicity and enhance anti-tumour response in patients with colorectal carcinoma subjected to chemotherapy.

Condition or disease Intervention/treatment Phase
Fasting Procedure: Fasting Not Applicable

Detailed Description:

Fasting for 24-48 hours during chemotherapy improves the response of the immune system against tumors and reduces chemotherapy toxicity through yet unknown mechanisms. The investigators have found that fasting induces the activation of p21, a protein that stops cell proliferation and plays important immune roles. The investigators hypothesize that p21 induction with short-term fasting enhances the immune anti-tumour response and reduces chemotherapy toxicity. To test this, half of the colorectal carcinoma (CRC) participants will follow 48 hours of fasting, 24 before and 24 after chemotherapy, under constant and specialized nutritional supervision. While the other half will follow a standard diet. A complete blood immunological profile at each chemotherapy cycle will be generated in collaboration with expert cytometrists, and gene expression, biochemical parameters, tumor evolution and toxicity markers will be measured. The investigators will (1) perform a complete analysis of immune cells to characterize the immune effects of fasting during chemotherapy; (2) analyze the effects of fasting on genes, metabolites and other molecules, to identify the responsible biological mechanisms, focusing on p21; (3) assess the reduction of chemotherapy toxicity in patients of colorectal carcinoma subjected to short-term fasting during chemotherapy.

Our project will further explore a safe, inexpensive, relatively unexplored and powerful nutritional intervention that can improve the quality of life and survival rates of millions of cancer patients: short-term fasting. Also, our project will have an important scientific impact, since previous reports have not yet described a clear mechanism explaining the beneficial effects of short-term fasting with chemotherapy

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Short-term Fasting Effects on Chemotherapy Toxicity and Efficacy
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2023

Arm Intervention/treatment
No Intervention: Standard diet
The participants will follow an standard diet during the chemotherapy treatment
Experimental: Fasting
The participants will follow a short-term fasting period for 44-48 hours, starting 24 hours before chemotherapy treatment
Procedure: Fasting
Food intake restriction




Primary Outcome Measures :
  1. Changes in the Common Terminology Criteria for Adverse Events CTCAE 5.0 toxicity table score. [ Time Frame: Baseline and after three weeks ]

    To evaluate changes in chemotherapy toxicity, the Common Terminology Criteria for Adverse Events (CTCAE) 5.0 toxicity table score will be calculated, taking into account different analysis and questionnaires on toxicity symptoms.

    Analysis will include:

    • Hematological analysis (erythrocytes, thrombocytes, white blood cells, Neutrophil/lymphocyte ratio and Platelet/lymphocyte ratio).
    • Biochemical analysis (sodium, potassium, calcium, phosphate, urea, creatinine, total protein, albumin, bilirubin, alkaline phosphatase, lactate dehydrogenase, alanine transaminase, aspartate transaminases, creatine kinase, troponin T, C Reactive Protein (CRP), cortisol and prealbumin)
    • Subjective symptoms obtained from health questionnaires (hunger, nausea, dizzying, weakness, diarrhea, constipation, gastroesophageal reflux disease)

  2. Changes in the immune response [ Time Frame: Baseline and after three weeks ]
    To evaluate the effect of short-term fasting on the immune response a complete immune phenotyping by flow cytometry will be done: cluster of differentiation 3 (CD3), cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8) (for T cells); cluster of differentiation 19 (CD19) (for B-cells), the high affinity Interleukin-2 receptor alpha subunit (CD45RA), CD62L (for T cell subsets: Memory, Effector); cluster of differentiation 25 (CD25) and cluster of differentiation 127 (CD127) (both for Treg cells); cluster of differentiation 11b C(D11b) (for granulocytes and macrophages); cluster of differentiation 14 (CD14) (for monocytes); cluster of differentiation antigen 16 (CD16), cluster of differentiation 56 (CD56) (NK cells); cluster of differentiation 15 (CD15) (for granulocytes and monocytes) markers will be analyzed

  3. Changes in the correlation between chemotherapy response and p21 and/or other fasting genes expression in peripheral blood mononuclear cells (PBMCs) [ Time Frame: Baseline and after three weeks ]
    The expression levels of p21 and/or fasting genes in peripheral blood mononuclear cells (PBMCs) will be correlated with toxicity parameters previously described in the primary outcome measure 1


Secondary Outcome Measures :
  1. Subjective evaluation of tolerance to fasting [ Time Frame: 48 hours of fasting, including 24 hours prior and 24 hours after chemotherapy administration. ]
    To evaluate the tolerance to fasting, participants will fill in a fasting tolerance test based on the symptoms they feel, this will result in a final score of tolerance to fasting.

  2. Changes in glycemia in response to fasting [ Time Frame: Baseline and after three weeks ]
    Glucose levels (milligrams per milliliter) will be measured with a kit from Abbott Laboratories, by enzymatic spectrophotometric assays using an Architect instrument from Abbot Laboratories.

  3. Changes in Free Fatty Acids levels in response to fasting [ Time Frame: Baseline and after three weeks ]
    Free fatty acids levels (moles per milliliter) will be evaluated with a kit from Abbott Laboratories, by enzymatic spectrophotometric assays using an Architect instrument from Abbott Laboratories.

  4. Changes in Insulin levels in response to fasting [ Time Frame: Baseline and after three weeks ]
    Insulin levels (International Units per milliliter) will be measured with a kit from Abbott Laboratories, by luminescent immunoassay using the Architect instrument from Abbott Laboratories.

  5. Changes ketone bodies in response to fasting [ Time Frame: Baseline and after three weeks ]
    Ketone bodies concentration (moles per milliliter) will be measured with a kit from Sigma-Aldrich, by an enzymatic spectrophotometric assay using an microplate reader from Thermo Fisher.

  6. Changes in gene expression in PBMCs after fasting [ Time Frame: Baseline and after three weeks ]

    To evaluate changes in gene expression in PBMCs the following fasting genes will be analyzed by qRTPCR:

    • p21
    • Pyruvate Dehydrogenase Kinase 4 (PDK4)
    • Carnitine palmitoyltransferase 1 (CPT1)
    • Adipophilin (ADFP)
    • Solute carrier family 25, member 50 (SLC25A50)

  7. Antitumoral response associated to fasting after chemotherapy treatment [ Time Frame: Baseline and after three weeks ]
    To evaluate the clinical antitumoral response, different tumoral markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen (Ca 19.9) will be analyzed in serum samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with malignant colorectal neoplasia
  • Good metabolic state (BMI>22)
  • Good nutritional tests
  • Normal Haematological and biochemical parameters
  • Normal renal and hepatic function
  • No loss of weight during the chemotherapy treatment

Exclusion Criteria:

  • BMI<22
  • Pregnancy or lactating women
  • Bad nutritional state
  • 3% weigh loss during the last month or more than 5% in the last three months
  • Diagnosis of type 2 diabetes mellitus or hypertension
  • Diagnosed hepatic, renal or cardiovascular disease
  • Respiratory of psychiatric disease
  • Nausea or vomiting, gastrointestinal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04247464


Locations
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Spain
IMDEA Food
Madrid, Spain, 28049
Sponsors and Collaborators
IMDEA Food
Hospital Infanta Sofia
Hospital Universitario La Paz
Investigators
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Principal Investigator: Enrique Casado, MD Hospital Universitario Infanta Sofia
Principal Investigator: Francisco Zambrana, MD Hospital Universitario Infanta Sofia
Principal Investigator: Pablo J Fernandez-Marcos, PhD IMDEA Food
Principal Investigator: Jaime Feliu, MD Hospital Universitario La Paz
Principal Investigator: Nuria Rodríguez-Salas, MD Hospital Universitario La Paz
Principal Investigator: Ismael Ghanem- Cañete, MD Hospital Universitario La Paz
Publications:

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Responsible Party: IMDEA Food
ClinicalTrials.gov Identifier: NCT04247464    
Other Study ID Numbers: HULP PI-3536
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IMDEA Food:
Short-term Fasting
Colorectal Cancer
Chemotherapy
Toxicity
Immune response