Quality of Life of PatientsNCT04009122
Evaluation of the Quality of Life of Patients With Metastatic Non-small Cell Lung Cancer With Supplementary Therapy With IGEN-0206
A study testing IGEN0206 in people with Quality of Life of Patients and Non-small Cell Lung Cancer Metastatic, run by Igen BioLab SLU at 25 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life of Patients, Non-small Cell Lung Cancer Metastatic
- What is being tested?
- IGEN0206
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 25 sitesSpain
- Study dates
- 11 Jun 2019to 14 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Spain25 sites
Complexo Hospitalario Universitario A Coruña
A Coruña, La Coruña, 15006
Hospital Público Virgen de los Lirios
Alcoy, Alicante, 03804
Hospital Universitario San Juan De Alicante
Alicante, 03550
Hospital Universitario Reina Sofía
Córdoba, 14004
Hospital del Henares
Coslada, Madrid, 28822
Hospital General Universitario de Elche
Elche, Alicante, 03203
Hospital General Universitario de Elda
Elda, Alicante, 03600
Hospital Lucus Augusti
Lugo, 27003
GenesisCare Madrid, Hospital La Milagrosa
Madrid, 28010
Hospital Sanitas La Zarzuela
Madrid, 28023
Hospital Universitario Infanta Leonor
Madrid, 28031
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Severo Ochoa
Madrid, 28914
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Regional de Málaga
Málaga, 29010
Hospital Universitario de Móstoles
Móstoles, Madrid, 28935
Complexo Hospitalario Universitario de Ourense
Ourense, Ourense, 32005
Hospital Universitario Son Llatzer
Palma de Mallorca, Palma, 07198
Hospital de Sagunto
Sagunto, Valencia, 46520
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, 28703
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Arnau de Vilanova
Valencia, 46015
Hospital Universitari i Politècnic La Fe
Valencia, 46026
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
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.
Read more
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).
- Being tested
- IGEN0206, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGEN0206Dietary supplement
Group A
PlaceboOther
Group B
| Study group | Role | What they receive |
|---|---|---|
| IGEN-0206 | Experimental | a sachet after each meal, preferably (3 sachets per day) Receives: Dietary Supplement: IGEN0206 |
| Placebo | Placebo comparator | a sachet after each meal, preferably (3 sachets per day) Receives: Other: Placebo |
| group C | No intervention | standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 52 weeks
Secondary outcomes (4)
BMI
Compare clinical benefits in terms of body mass index (BMI) in the three treatment arms.
Measured: 52 weeks
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.
Measured: 12 weeks
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.
Measured: 52 weeks
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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start11 Jun 2019
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quality of Life of PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igen BioLab SLU
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009122
- Sponsor's protocol ID
- IGEN0206-15
- Status last verified
- May 2023
- First submitted
- 25 Jun 2019
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All collected IPD
Publications
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.
PubMed 11527672Bunn 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.
PubMed 9607565Cappuzzo 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.
PubMed 20493771
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality of Life of Patients With Metastatic Non-small Cell Lung Cancer With Supplementary Therapy With IGEN-0206
- ClinicalTrials.gov ID
- NCT04009122
- Acronym / sponsor ID
- IGEN0206-15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Igen BioLab SLUIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IGEN-0206 | Experimental | Dietary Supplement: IGEN0206a sachet after each meal, preferably (3 sachets per day) |
| Placebo | Placebo comparator | Other: Placeboa sachet after each meal, preferably (3 sachets per day) |
| group C | No intervention | –standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGEN0206Group A | Dietary supplement | IGEN-0206 |
| PlaceboGroup B | Other | Placebo |
Primary outcome
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
4 secondary outcomes
BMI
Time frame: 52 weeks
Changes in the microbiota
Time frame: 12 weeks
Interleukin levels
Time frame: 52 weeks
Cytokines levels
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Background: PubMed 11527672Barber 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.
- Background: PubMed 9607565Bunn 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.
- Background: PubMed 20493771Cappuzzo 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.
- Individual participant dataSharing planned: Undecided. All collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IGEN0206 in people with Quality of Life of Patients and Non-small Cell Lung Cancer Metastatic, run by Igen BioLab SLU at 25 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04009122, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.