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

IMDEA Food

Status: Completed

Conditions: Fasting

Treatments: Procedure: Fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT04247464

HULP PI-3536

Details and patient eligibility

About

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.

Full 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

Enrollment: 11 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Standard diet

No Intervention group

Description:

The participants will follow an standard diet during the chemotherapy treatment

Fasting

Experimental group

Description:

The participants will follow a short-term fasting period for 44-48 hours, starting 24 hours before chemotherapy treatment

Treatment:

Procedure: Fasting