IGEN0206
Dietary SupplementGroup A
NCT Number: NCT04009122
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hospital Público Virgen de los Lirios, Alcoy, Alicante, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group A
Group B
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
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
Time frame: 52 weeks
Compare clinical benefits in terms of body mass index (BMI) in the three treatment arms.
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.
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.
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.
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.
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.
Time frame: 52 weeks
Time elapsed from randomization until death is documented for any reason
Time frame: 52 weeks
The sum of the complete and partial answers
Time frame: 52 weeks
The sum of stable disease and partial / total response.
Time frame: 52 weeks
To assess tolerability in terms of interruptions or delays in active oncological treatment by adding IGEN-0206
Igen BioLab SLU
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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