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

Non-small Cell Lung Cancer Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04009122
• Other study ID #: IGEN0206-15
• Status: Completed
• Phase: N/A
• Start date: June 11, 2019
• Est. completion date: December 14, 2022

Study information

• Verified date: May 2023
• Source: Igen BioLab SLU
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Metastatic
• Quality of Life of Patients

Intervention

Dietary Supplement:
• IGEN0206
Group A

Other:
• Placebo
Group B

Locations

Country	Name	City	State
Spain	Complexo Hospitalario Universitario A Coruña	A Coruña	La Coruña
Spain	Hospital Público Virgen de los Lirios	Alcoi	Alicante
Spain	Hospital Universitario San Juan De Alicante	Alicante
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital del Henares	Coslada	Madrid
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	Hospital General Universitario de Elda	Elda	Alicante
Spain	Hospital Lucus Augusti	Lugo
Spain	GenesisCare Madrid, Hospital La Milagrosa	Madrid
Spain	Hospital Sanitas La Zarzuela	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Severo Ochoa	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Regional de Málaga	Málaga
Spain	Hospital Universitario de Móstoles	Móstoles	Madrid
Spain	Complexo Hospitalario Universitario de Ourense	Orense	Ourense
Spain	Hospital Universitario Son Llatzer	Palma De Mallorca	Palma
Spain	Hospital de Sagunto	Sagunto	Valencia
Spain	Hospital Universitario Infanta Sofía	San Sebastián De Los Reyes	Madrid
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital Universitari i Politècnic La Fe	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Igen BioLab SLU

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Adverse events	To compare adverse events (AEs) in the three treatment groups according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.1.	52 weeks
Other	Progression-free survival	Time from randomization until the progression of the disease or death from any cause is documented. To compare the efficacy in terms of response and survival among the three arms of the study.	52 weeks
Other	Overall survival	Time elapsed from randomization until death is documented for any reason	52 weeks
Other	Objective response rate	The sum of the complete and partial answers	52 weeks
Other	Disease control	The sum of stable disease and partial / total response.	52 weeks
Other	Number of oncological treatment interruptions	To assess tolerability in terms of interruptions or delays in active oncological treatment by adding IGEN-0206	52 weeks
Primary	Impact of IGEN-0206 on quality of life in patients with metastatic lung cancer according to the EORTC QLQ-C30.	The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.; Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional	52 weeks
Primary	Impact of IGEN-0206 on quality of life in patients with metastatic lung cancer according to the EORTC QLQ-L13	The QLQ-LC13 incorporates one multi-item scale to assess dyspnoea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and haemoptysis.; All of the scales and single-item measures range in score from 0 to 100. A high score for the scales and single items represents a high level of symptomatology or problems	52 weeks
Secondary	BMI	Compare clinical benefits in terms of body mass index (BMI) in the three treatment arms.	52 weeks
Secondary	Changes in the microbiota	Compare changes in the microbiota profile in terms of microbiota metabolism (faecal samples) in the three treatment arms with proteomics and genomics methods.	12 weeks
Secondary	Interleukin levels	To evaluate the changes in the inflammatory and immune response and to identify immunological biomarkers in the blood with predictive power and prognosis.	52 weeks
Secondary	Cytokines levels	To evaluate the changes in the inflammatory and immune response and to identify immunological biomarkers in the blood with predictive power and prognosis.	52 weeks