Clinical trial NCT04009122: Evaluation of the Quality of Life of Patients With Metastatic Non-small Cell Lung Cancer With Supplementary Therapy With IGEN-0206
Official title: Evaluation of the Quality of Life of Patients With Metastatic Non-small Cell Lung Cancer With Supplementary Therapy With IGEN-0206
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life of Patients
Non-small Cell Lung Cancer Metastatic
Lead sponsor: Igen BioLab SLU
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* Patient who has given informed consent in writing, stating that he / she understands the purpose of the study and the procedures it entails, and that he / she agrees to participate.
* Patient with metastatic non-small cell lung carcinoma confirmed by Pathology.
* Expected life expectancy exceeding 12 weeks.
* Age ≥18 years.
* Functional status of the ECOG 1-3.
* Patients who can consume at least 500 ml per day of the nutritional supplement, added to their diet.
* Patients who do not meet criteria for renal failure: the glomerular filtrate, calculated by local formula, must be ≥60 ml / min / 1.73m2.
* Patients who are willing to communicate the use of nutritional supplements, including oral supplements, vitamins and mineral supplements and / or any food supplement
* Patients who are willing to comply with the protocol procedures after having been thoroughly informed about the treatment, the procedures, reviewing the study methodology and signing the informed consent.
* They speak fluent Spanish in order to be able to complete the questionnaires of the study.
* Potentially fertile women must be negative in a serum pregnancy test performed within 7 days prior to entry into the study. Potentially fertile patients participating in this study should use effective contraceptive methods (eg, abstinence, intrauterine device, oral or injectable contraceptives, double-barrier method, or surgical sterilization) to prevent pregnancy, which they will begin to use as of signature of the informed consent document and whose use will continue until at least 13 weeks after the last dose of the study medication has been administered.

Exclusion Criteria:

* Women who are pregnant and / or breast-feeding.
* Persistence of the toxicity of a previous treatment (grade\> 1 of the NCI-CTCAE v. 4.03); However, alopecia and sensory neuropathy of grade ≤ 2 are acceptable, as well as other side effects that do not endanger patient safety in the opinion of the researcher.
* Evidence of severe or uncontrolled systemic disease or concomitant process that, in the opinion of the investigator, makes the participation of the subject in the study inadvisable or compromises compliance with the protocol.
* Dementia or mental state significantly altered that could interfere in the understanding and granting of informed consent.
* Parkinson's disease

Primary outcomes:
measure: Impact of IGEN-0206 on quality of life in patients with metastatic lung cancer according to the EORTC QLQ-C30.
timeFrame: 52 weeks
measure: Impact of IGEN-0206 on quality of life in patients with metastatic lung cancer according to the EORTC QLQ-L13
timeFrame: 52 weeks
Secondary outcomes:
measure: BMI
timeFrame: 52 weeks
measure: Changes in the microbiota
timeFrame: 12 weeks
measure: Interleukin levels
timeFrame: 52 weeks
measure: Cytokines levels
timeFrame: 52 weeks
Other outcomes:
measure: Number of Adverse events
timeFrame: 52 weeks
measure: Progression-free survival
timeFrame: 52 weeks
measure: Overall survival
timeFrame: 52 weeks
measure: Objective response rate
timeFrame: 52 weeks
measure: Disease control
timeFrame: 52 weeks
measure: Number of oncological treatment interruptions
timeFrame: 52 weeks
Locations:
city: Alcoi
country: Spain
facility: Hospital Público Virgen de los Lirios
state: Alicante
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Elda
country: Spain
facility: Hospital General Universitario de Elda
state: Alicante
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
state: La Coruña
city: Coslada
country: Spain
facility: Hospital del Henares
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Universitario de Móstoles
state: Madrid
city: San Sebastián De Los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofía
state: Madrid
city: Orense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
state: Ourense
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Llatzer
state: Palma
city: Sagunto
country: Spain
facility: Hospital de Sagunto
state: Valencia
city: Alicante
country: Spain
facility: Hospital Universitario San Juan De Alicante
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Lugo
country: Spain
facility: Hospital Lucus Augusti
city: Madrid
country: Spain
facility: GenesisCare Madrid, Hospital La Milagrosa
city: Madrid
country: Spain
facility: Hospital Sanitas La Zarzuela
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Severo Ochoa
city: Málaga
country: Spain
facility: Hospital Regional de Málaga
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
References:
citation: Barber MD. Cancer cachexia and its treatment with fish-oil-enriched nutritional supplementation. Nutrition. 2001 Sep;17(9):751-5. doi: 10.1016/s0899-9007(01)00631-1.
citation: Bunn PA Jr, Kelly K. New chemotherapeutic agents prolong survival and improve quality of life in non-small cell lung cancer: a review of the literature and future directions. Clin Cancer Res. 1998 May;4(5):1087-100.
citation: Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, Esteban E, Molinier O, Brugger W, Melezinek I, Klingelschmitt G, Klughammer B, Giaccone G; SATURN investigators. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010 Jun;11(6):521-9. doi: 10.1016/S1470-2045(10)70112-1. Epub 2010 May 20.