Effect of the Nutraceutical "MICODIGEST 2.0" on the Complications After Surgery for Colorectal Cancer

NCT ID: NCT04821258

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2022-09-30

Brief Summary

Most of Colorectal cancer (CRC) diagnosed are candidates for surgical resection with curative intent, although colorectal surgery is associated with some complications that could be life-threatening. Antibiotic prophylaxis is commonly used prior to the admission for the prevention of postoperative complications. However, this intervention can change the composition of intestinal microbiota and promote adverse inflammatory outcomes in CRC patients after surgery.

It seems the combination of different fungal extracts could be beneficial because of their role in gut microbiota modulation and their anti-inflammatory activity. Therefore, the fungal extract nutraceutical MICODIGEST 2.0 could be used to reduced the complications after CRC surgery.

Based on this hypothesis, we have designed a double-bind randomized clinical trial to evaluate the effect of MICODIGEST 2.0 on the complications after surgery with curative intent for CRC.

Detailed Description

Colorectal cancer (CRC) is one of the most common malignancies in western countries. Most of the CRC diagnosed are candidates for surgical resection with curative intent. Cure rates after surgery vary between 92 % and 67 % depending on the tumor stage. However, colorectal surgery is associated with some complications that could be life-threatening.

Antibiotic prophylaxis is commonly used prior to the admission for the prevention of this postoperative complications. Several studies have shown that antibiotic administration reduces the risk of infections associated with surgery. Nevertheless, this intervention does not modify the mortality and severity of other complications detected. Further, antibiotic prophylaxis could change the intestinal microbiota and promote adverse inflammatory outcomes in CRC patients after surgery.

Fungal polysaccharides have attracted attention because of their role in gut microbiota modulation. It seems that this type of polysaccharides could reduce pathogen levels and stimulate the growth of beneficial microorganism. Anti-inflammatory activity has also been described for these fungal polysaccharides. It seems the combination of different fungal extracts would send multiple stimuli to the immune system increasing intracellular reactions and interactions. Thus, the fungal extract nutraceutical MICODIGEST 2.0 could be used to reduced the complications after CRC surgery. MICODIGEST 2.0 is available since 2016 without any adverse effect reported.

For all these reasons we have designed a double-bind randomized clinical trial to evaluate the effect of MICODEGIST 2.0 on the complications after surgery with curative intent for CRC.

Apart from this purpose, we have also set the following secondary objectives:

• To evaluate the safety of MICODIGEST 2.0 in CRC patients.
• To evaluate the effect of MICODIGEST 2.0 on feal microbiome composition and diversity.
• To evaluate the effect of MICODIGEST 2.0 on inflammatory pattern, dietary pattern and quality of life.
• To analyze the effect of microbiome, inflammatory and dietary pattern on complications after surgery.

Conditions

Colorectal Cancer; Surgery--Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

MICODIGEST 2.0 supplement

Treatment with MICODIGEST 2.0 will initiate with 10mL/day (before breakfast or before lunch) for 7 days, and rise to 20mL/day (10mL before breakfast and 10 mL before dinner) for 4-6 weeks.

Group Type: EXPERIMENTAL

MICODIGEST 2.0 supplement

Intervention Type: DIETARY_SUPPLEMENT

MICODIGEST is a nutraceutical which contains 9 different fungal extracts: Ganoderma lucidum, Agaricus blazei, Grifola frondosa, Hericium erinaceus, Cordyceps sinensis, Inonotus obliquus, Pleurotus ostreatus, Polyporus umbellatus y Lentinula edodes

Placebo

Treatment with placebo will initiate with 10mL/day (before breakfast or before lunch) for 7 days, and rise to 20 mL/day (before breakfast and before dinner) for 4-6 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Interventions

MICODIGEST 2.0 supplement

MICODIGEST is a nutraceutical which contains 9 different fungal extracts: Ganoderma lucidum, Agaricus blazei, Grifola frondosa, Hericium erinaceus, Cordyceps sinensis, Inonotus obliquus, Pleurotus ostreatus, Polyporus umbellatus y Lentinula edodes

Intervention Type: DIETARY_SUPPLEMENT

Placebo supplement

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. CRC patients who are candidates for surgical treatment with curative intent (risk I-III).

2. American Society of Anesthesiologists' Physical Status Classification (ASA) <3.

3. Patients aged between 18 and 85 years.

4. Eastern Cooperative Oncology Group (ECOG) scale between 0-2.

5. Patients with preserved cognitive function.

6. Patient's authorization after reading the study information sheet.

Exclusion Criteria

1. Candidates for neoadjuvant therapy.

2. Patients with concomitant carcinoma.

3. Allergy to the supplied nutraceutical or presence of malabsorption syndrome.

4. Presence of mental disorders

5. Patient with active infection or antibiotic therapy in the last month.

6. Previous colorectal surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacin Biomedica Galicia Sur

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Joaquín Cubiella, MD PhD

Role: CONTACT

joaquin.cubiella.fernandez@sergas.es

0034988385824

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Related Links

https://gco.iarc.fr/today/home

World Health Organization. Cancer Today. International Agency for Research on Cancer. (2020)

Other Identifiers

COGOMELO 2.0

Identifier Type: -

Identifier Source: org_study_id