Evaluation of the Quality of Life of Patients With Metast... | NCT04009122

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
IGEN0206	Dietary Supplement	Group A	IGEN-0206
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
BMI	Compare clinical benefits in terms of body mass index (BMI) in the three treatment arms.	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.

Other Outcomes

Measure	Description	Time Frame
Number of Adverse events	To compare adverse events (AEs) in the three treatment groups according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.1.	52 weeks
Progression-free survival

Eligibility Module

Eligibility 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

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Público Virgen de los Lirios		Alcoy	Alicante	03804	Spain
Hospital General Universitario de Elche

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11527672	Background	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.
9607565	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.