NCT04009122

Evaluation of the Quality of Life of Patients With Metastatic Non-small Cell Lung Cancer With Supplementary Therapy With IGEN-0206

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Igen BioLab SLU · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A national, multicenter, blind, randomized study of three groups, designed to evaluate the impact on the quality of life of IGEN-0206 (IGEN-0206 is a nutritional product, a food) with nutritional support + standard treatment versus nutritional support + standard treatment versus standard treatment in patients with non-lung cancer metastatic microcytic. The standard treatment can include any line of active treatment (chemotherapy, immunotherapy, biological therapies or targeted therapies), radiotherapy or nonspecific symptomatic treatment. It will include 280 patients older than 18 years, who have a life expectancy of less than 9 months, who will receive or not active treatment. After signing the informed consent and confirmation that the subject meets the eligibility criteria, those will be randomized (2: 2: 1 ratio) to receive treatment: * Group A (112 patients): patients will receive their standard treatment + nutritional support + IGEN-0206 * Group B (112 patients): patients will receive their standard treatment + nutritional support + placebo. * Group C (56 patients): patients will receive standard treatment. The allocation will be random 2: 2: 1 and will be stratified according to ECOG 1 versus 2-3, type of oncological treatment (chemotherapy, immunotherapy and / or radiotherapy versus targeted therapies versus symptomatic treatment) and type of cancer (squamous versus not flaky). The present study seeks to demonstrate that IGEN-0206 improves the quality of life and the nutritional status of patients with non-small cell lung cancer. If an improvement in the quality of life is achieved, this could impact on a reduction in the number of treatment delays / omissions, which could secondarily impact on a response and survival benefit (by improving the relative intensity of the active oncological treatment).

Conditions

• Quality of Life of Patients
• Non-small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	IGEN0206	Group A
OTHER	Placebo	Group B

Timeline

• Start date: 2019-06-11
• Primary completion: 2022-12-14
• Completion: 2022-12-14
• First posted: 2019-07-05
• Last updated: 2023-05-16

Locations

25 sites across 1 country: Spain