Lymphocyte Enhancement in Gastroenteric Oncology

NCT06343272 | Recruiting

• 1 other identifier: LEGO
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

LEGO is single center double-blind randomized trial aimed at testing the efficacy of an essential ammino acid (EAA) supplementation in improving the absolute count of peripheral lymphocytes and the tolerance to chemotherapy in patients with advanced gastrointestinal malignancies not candidates to immune check-point inhibitors containing regimens.

Conditions

Advanced Gastrointestinal Cancers

Outcome Measures

Primary Outcomes (1)

• Exit from lymphopenia

  Proportion of patients exceeding the lymphopenia threshold level of 29.7%.

  60 days

Secondary Outcomes (4)

• The change in the % of lymphocytes over time

  0, 30, 60, 90 days

• The proportion of patients with G3-G5 toxicity

  60 days

• The percentage of chemotherapy dose administered compared to that expected for the patients.

  60 days

• plasma aminoacids composition chang during treatment

  60 days

Study Arms (2)

Sperimental

EXPERIMENTAL

Dietary Supplement: EAA supplementation

Isocaloric placebo

PLACEBO COMPARATOR

Other: Isocaloric placebo

Interventions

EAA supplementation DIETARY_SUPPLEMENT

The experimental group will receive the mixture (Amino-Ther® PRO, Professional Dietetics, Milan) composed of (in mg): L-leucine 1200, l L-isine 900, L-threonine 700, L-isoleucine 600, L-valine 600, L-cystine 150, L histidine 150, L-phenylalanine 100, L-methionine 50, L-tryptophan 50, vitamin B6 0.85, vitamin B1 0.70, citric acid 409, acidomalic 102.5, succinic acid 102.5. 1 sachet dissolved in 150 ml of water at 10.00 am +1 sachet at 4.00 pm daily for 60 days There are: proteins 0.00 g, carbohydrates 2.1 g, fats 0.00 g

Sperimental

Isocaloric placebo OTHER

The control group will take 25g of maltodextrins daily with the same methods as the treated group: 1 sachet dissolved in 150 ml of water at 10.00 am +1 sachet at 4.00 pm daily for 60 days

Isocaloric placebo

Eligibility Criteria

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

You may qualify if:

• diagnosis of epithelial neoplasia of the gastrointestinal tract in advanced stage with indication for first-line chemotherapy for palliative purposes and with circulating lymphocytes \< 29.7% of the number total white blood cells in the blood.
• ECOG PS ≤ 2
• start of first-line palliative chemotherapy agreement with AIOM guidelines.
• adequate nutritional counseling carried out before starting of the treatment
• willing to participate by providing written informed consent

You may not qualify if:

• age \< 18 years
• current or indicated artificial nutrition
• gluten intolerance
• prediction of use of granulocyte growth factors
• confirmed diagnosis of COPD, chronic heart failure, insufficiency chronic kidney disease, chronic liver failure, collagen disease, diseases endocrine, insulin-dependent diabetes, malignancy in other locations. All these conditions are associated with documented alterations in the plasma profile of amino acids and potentially of subsets of circulating T lymphocytes.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• University of Pavia: collaborator

Study Sites (1)

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: March 22, 2022
• Primary Completion: December 22, 2024
• Study Completion: February 28, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

IT (1)