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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
Sponsor:
Information provided by (Responsible Party):
Igen BioLab SLU

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).


Condition or disease Intervention/treatment Phase
Quality of Life of Patients Non-small Cell Lung Cancer Metastatic Dietary Supplement: IGEN0206 Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IGEN-0206
a sachet after each meal, preferably (3 sachets per day)
Dietary Supplement: IGEN0206
Group A

Placebo Comparator: Placebo
a sachet after each meal, preferably (3 sachets per day)
Other: Placebo
Group B

No Intervention: group C
standard treatment



Primary Outcome Measures :
  1. 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


  2. 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



Secondary Outcome Measures :
  1. BMI [ Time Frame: 52 weeks ]
    Compare clinical benefits in terms of body mass index (BMI) in the three treatment arms.

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. Overall survival [ Time Frame: 52 weeks ]
    Time elapsed from randomization until death is documented for any reason

  4. Objective response rate [ Time Frame: 52 weeks ]
    The sum of the complete and partial answers

  5. Disease control [ Time Frame: 52 weeks ]
    The sum of stable disease and partial / total response.

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Carmen Perezagua, Physician 00349115960 00 c.perezagua@igenbiotechgroup.com

Locations
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Sponsors and Collaborators
Igen BioLab SLU
Publications:
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Responsible Party: Igen BioLab SLU
ClinicalTrials.gov Identifier: NCT04009122    
Other Study ID Numbers: IGEN0206-15
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All collected IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms