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

NCT04009122 | Completed

• 1 other identifier: IGEN0206-15
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 25

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• BMI

  52 weeks

• Changes in the microbiota

  12 weeks

• Interleukin levels

  52 weeks

• Cytokines levels

  52 weeks

Other Outcomes (6)

• Number of Adverse events

  52 weeks

• Progression-free survival

  52 weeks

• Overall survival

  52 weeks

Study Arms (3)

IGEN-0206

EXPERIMENTAL

a sachet after each meal, preferably (3 sachets per day)

Dietary Supplement: IGEN0206

Placebo

PLACEBO COMPARATOR

a sachet after each meal, preferably (3 sachets per day)

Other: Placebo

group C

NO INTERVENTION

standard treatment

Interventions

IGEN0206 DIETARY_SUPPLEMENT

Group A

IGEN-0206

Placebo OTHER

Group B

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Igen BioLab SLU: lead

Study Sites (25)

Hospital Público Virgen de los Lirios

Alcoy, Alicante, 03804, Spain

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital General Universitario de Elda

Elda, Alicante, 03600, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Complexo Hospitalario Universitario A Coruña

A Coruña, La Coruña, 15006, Spain

Location

Hospital del Henares

Coslada, Madrid, 28822, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario de Móstoles

Móstoles, Madrid, 28935, Spain

Location

Hospital Universitario Infanta Sofía

San Sebastián de los Reyes, Madrid, 28703, Spain

Location

Complexo Hospitalario Universitario de Ourense

Ourense, Ourense, 32005, Spain

Location

Hospital Universitario Son Llatzer

Palma de Mallorca, Palma, 07198, Spain

Location

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

Location

Hospital Universitario San Juan De Alicante

Alicante, 03550, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Lucus Augusti

Lugo, 27003, Spain

Location

GenesisCare Madrid, Hospital La Milagrosa

Madrid, 28010, Spain

Location

Hospital Sanitas La Zarzuela

Madrid, 28023, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Severo Ochoa

Madrid, 28914, Spain

Location

Hospital Regional de Málaga

Málaga, 29010, Spain

Location

Hospital Arnau de Vilanova

Valencia, 46015, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related 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.

  PMID: 11527672 BACKGROUND

• 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.

  PMID: 9607565 BACKGROUND

• 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.

  PMID: 20493771 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 5, 2019
• Study Start: June 11, 2019
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

ES (25)