Evaluation of the Quality of Life of Patients With Metastatic Non-small Cell Lung Cancer With Supplementary Therapy With IGEN-0206
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|ClinicalTrials.gov Identifier: NCT04009122|
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : February 16, 2021
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).
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life of Patients Non-small Cell Lung Cancer Metastatic||Dietary Supplement: IGEN0206 Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of the Quality of Life of Patients With Metastatic Non-small Cell Lung Cancer With Supplementary Therapy With IGEN-0206|
|Actual Study Start Date :||June 11, 2019|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2022|
a sachet after each meal, preferably (3 sachets per day)
Dietary Supplement: IGEN0206
Placebo Comparator: Placebo
a sachet after each meal, preferably (3 sachets per day)
No Intervention: group C
- Impact of IGEN-0206 on quality of life in patients with metastatic lung cancer according to the EORTC QLQ-C30. [ Time Frame: 52 weeks ]
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
- Impact of IGEN-0206 on quality of life in patients with metastatic lung cancer according to the EORTC QLQ-L13 [ Time Frame: 52 weeks ]
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
- BMI [ Time Frame: 52 weeks ]Compare clinical benefits in terms of body mass index (BMI) in the three treatment arms.
- Changes in the microbiota [ Time Frame: 12 weeks ]Compare changes in the microbiota profile in terms of microbiota metabolism (faecal samples) in the three treatment arms with proteomics and genomics methods.
- Interleukin levels [ Time Frame: 52 weeks ]To evaluate the changes in the inflammatory and immune response and to identify immunological biomarkers in the blood with predictive power and prognosis.
- Cytokines levels [ Time Frame: 52 weeks ]To evaluate the changes in the inflammatory and immune response and to identify immunological biomarkers in the blood with predictive power and prognosis.
- Number of Adverse events [ Time Frame: 52 weeks ]To compare adverse events (AEs) in the three treatment groups according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.1.
- Progression-free survival [ Time Frame: 52 weeks ]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.
- Overall survival [ Time Frame: 52 weeks ]Time elapsed from randomization until death is documented for any reason
- Objective response rate [ Time Frame: 52 weeks ]The sum of the complete and partial answers
- Disease control [ Time Frame: 52 weeks ]The sum of stable disease and partial / total response.
- Number of oncological treatment interruptions [ Time Frame: 52 weeks ]To assess tolerability in terms of interruptions or delays in active oncological treatment by adding IGEN-0206
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009122
|Contact: Carmen Perezagua, Physician||00349115960 firstname.lastname@example.org|