Advanced CancerNCT06363201
Effect and Safety of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours
A study testing Ocoxin Oral solution in people with Advanced Cancer and Advanced Solid Tumor, run by Catalysis SL at 1 site in Honduras.
Trial summary
Exploratory study to evaluate the effect and safety of the use of Ocoxin® oral solution on the quality of life of paediatric patients with advanced stage solid tumours. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Advanced Cancer, Advanced Solid Tumor, Lymphoma, Hodgkin
- What is being tested?
- Ocoxin Oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHonduras
- Study dates
- 28 Apr 2024to 15 Dec 2025
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient of either sex in the paediatric age group, between 7 and 18 years of age.
- Father, mother or legal guardian who consents in writing to the minor's participation in the study. Written consent of the minor for ages 12 to 18 years. Verbal consent of the minor for ages 7 to 11 years.
- Histologically confirmed diagnosis of solid tumour of any location, in advanced stage, with criteria to receive oncospecific therapy.
- Patients with haematological parameters within normal figures that allow them to receive oncospecific therapy, according to the management protocols for each of the diseases.
Who cannot join
- Pregnancy or breast-feeding (if less than 3 months have elapsed since delivery, abortion, or breast-feeding prior to the start of treatment).
- Hypersensitivity to any component of the product under study (Ocoxin®).
- Any disease or condition that could interfere with the interpretation of the results.
Trial locations and contacts
1 site in 1 country.
Honduras1 site
Hospital Escuela, Tegucigalpa (Honduras)
Tegucigalpa, Francisco Morazán Department, 504
Ingrid C. Arambú Elvir, Dr., 50498878486, ingridcarolinaa@yahoo.com
Ingrid C. Arambú Elvir, Dr.
About this study
Official title: Exploratory Study to Evaluate the Effect and Safety of the Use of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours
Exploratory study to evaluate the effect and safety of the use of Ocoxin® oral solution on the quality of life of paediatric patients with advanced stage solid tumours.
Read the detailed description
This is a prospective, open-label, single-centre, exploratory study in paediatric patients with advanced stage solid tumours receiving oncospecific therapy.
Ocoxin®: The research product, registered as a nutritional supplement (Ocoxin®, oral solution), manufactured by Catalysis S.L. of Spain. It comes in the form of 30 ml single-dose vials.
Forty paediatric patients will be included, distributed as follows: Hodgkin's lymphoma (10), Central Nervous System tumours (10), Sarcoma of any type (10) or Germinal Tumours (10).
Patients will receive one vial of Ocoxin® daily from the start of oncospecific therapy until two weeks after the end of therapy.
Prior to the start of treatment and before each cycle of QT, a haemogram and haemochemistry including albumin, total proteins, transaminases (TGO, TGP) will be performed. Physical examinations will be performed, and the patient's vital signs and body weight will be evaluated.
Prior to the start of treatment, in month three and four weeks after the end of oncospecific therapy, a CT scan will be performed (depending on the type of tumour, the system for evaluating the efficacy of the oncospecific treatment will be adapted).
Quality of life will be assessed using the paediatric quality of life questionnaire (PedsQLTm, version 4.0. Spanish). The questionnaire will be administered to the parent or guardian prior to the start of treatment, at month 3 and at the end of treatment with Ocoxin®. In the case of longer treatment regimens, intermediate quality of life measurements may be taken after the three months and before the end of treatment.
The influence of Ocoxin® Oral solution on the prevention of admissions due to toxicity attributable to cancer-specific therapy and changes in the patient's nutritional status will also be assessed.
Safety will be assessed by collecting adverse events (AEs), analytical parameters, physical examinations and vital signs.
Effect and safety variables will be summarised using descriptive statistics and frequency counts.
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Lymphoma, Hodgkin, Central Nervous System Tumor, Sarcoma, Germ Cell Tumor
- Being tested
- Ocoxin Oral solution
- Keywords
- Epigallocatechin gallate, Paediatric, Advanced Solid Tumor, Quality of Life
- Medical subject headings
- Hodgkin Disease, Central Nervous System Neoplasms, Sarcoma, Neoplasms, Germ Cell and Embryonal, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocoxin Oral solutionDietary supplement
Patients will receive one vial of Ocoxin® orally daily, preferably at the same time each day. The duration of treatment will depend on the chemotherapy schedule the patient will receive. Treatment with Ocoxin® will be from the start of oncospecific therapy until two weeks after the end of therapy.
| Study group | Role | What they receive |
|---|---|---|
| Ocoxin Oral Solution | Experimental | Patients will receive one vial of Ocoxin® daily from the start of oncospecific therapy until two weeks after the end of therapy. Receives: Dietary Supplement: Ocoxin Oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Qualitative and quantitative data collection. To assess the effect of Ocoxin® on the quality of life of paediatric patients with advanced solid tumours by the Paediatric Quality of Life Questionnaire (PedsQLTm, version 4.0. Spanish). The questionnaire will be administered to the parent or guardian prior to the start of treatment, at month 3 and at the end of treatment with Ocoxin®. In the case of longer treatment regimens, intermediate quality of life measurements may be taken after the three-month treatment and before the end of treatment.
Measured: 7 months
Secondary outcomes (6)
Degree of toxicity related to oncospecific treatment
Qualitative and quantitative data collection. To evaluate the influence of Ocoxin® in the prevention of admissions due to toxicity to cancer-specific therapy (NCI-CTC scales). Admissions for toxicity. Information related to the need for admissions for mucositis (World Health Organization mucositis grade) or other causes shall be collected at each assessment during treatment and at the final assessment.
Measured: 7 months
Nutritional Status
Qualitative and quantitative data collection. Changes in nutritional status. This will be assessed through body mass index (BMI) behavior at baseline, intermediate assessments, and final assessments.
Measured: 7 months
Presence of Adverse Events (AE)
Qualitative and quantitative data collection. Product and non-product related adverse events described and classified as follows:
Occurrence of any AE: yes/no Type: described according to the CTC nomenclature version 5.0 Duration: To be assessed by the start and end dates of the adverse event Intensity: To be assessed by the categories mild, moderate, severe, serious life-threatening or disabling, or serious life-threatening.
Causality: assessed as highly probable/certain, probable, possible, possible, unlikely, unrelated, and not assessable/unclassifiable Severity: yes/no. In case of yes, it will be classified according to the categories of: causes death of the patient, threatens life, requires hospitalisation or prolongs an existing hospitalisation, causes disability, significant or persistent disability, causes a birth defect or congenital anomaly.
Outcome: To be assessed according to the categories of recovered, improved, persists or sequelae.
Measured: 7 months
Metabolic Status
Qualitative and quantitative data collection. The metabolic status of patients will be assessed by laboratory tests. The tests described in the evaluations will be performed according to the study schedule (haemogram, albumin, total proteins, TGP, TGO). They will be classified as normal, non-clinically significant abnormal and clinically significant abnormal. Clinically significant abnormal findings in laboratory parameters will be reported as AE.
Measured: 7 months
Physical Status
Qualitative data collection. The physical status of patients shall be assessed by physical examination. The patient will be examined prior to study initiation, at on-treatment assessments, and at the end-of-treatment assessment. Any positive findings of clinical relevance on physical examination will be considered as an adverse event and will be described and classified as defined in the protocol for this type of event.
Measured: 7 months
Response to oncospecific treatment
Qualitative data collection (the evaluation method used will also include RECIST criteria, iRECIST criteria, Cheeson criteria or other, in which case the method will be specified). Objective response to oncospecific treatment will be assessed by characterising the type of response after clinical evaluation of the patient at the end of the chemotherapy regimen. This will be classified as complete response, partial response, disease stabilisation or progression, following the response criteria established for each treatment protocol according to the underlying disease treated.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start28 Apr 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363201
- Sponsor's protocol ID
- CAT2024/PED01
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Steliarova-Foucher E, Colombet M, Ries LAG, Moreno F, Dolya A, Bray F, Hesseling P, Shin HY, Stiller CA; IICC-3 contributors. International incidence of childhood cancer, 2001-10: a population-based registry study. Lancet Oncol. 2017 Jun;18(6):719-731. doi: 10.1016/S1470-2045(17)30186-9. Epub 2017 Apr 11.
PubMed 28410997Lam CG, Howard SC, Bouffet E, Pritchard-Jones K. Science and health for all children with cancer. Science. 2019 Mar 15;363(6432):1182-1186. doi: 10.1126/science.aaw4892.
PubMed 30872518Gohar SF, Comito M, Price J, Marchese V. Feasibility and parent satisfaction of a physical therapy intervention program for children with acute lymphoblastic leukemia in the first 6 months of medical treatment. Pediatr Blood Cancer. 2011 May;56(5):799-804. doi: 10.1002/pbc.22713. Epub 2011 Jan 16.
PubMed 21370414Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499Varni JW, Katz ER, Seid M, Quiggins DJ, Friedman-Bender A, Castro CM. The Pediatric Cancer Quality of Life Inventory (PCQL). I. Instrument development, descriptive statistics, and cross-informant variance. J Behav Med. 1998 Apr;21(2):179-204. doi: 10.1023/a:1018779908502.
PubMed 9591169Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
PubMed 11932914Joffe L, Ladas EJ. Nutrition during childhood cancer treatment: current understanding and a path for future research. Lancet Child Adolesc Health. 2020 Jun;4(6):465-475. doi: 10.1016/S2352-4642(19)30407-9. Epub 2020 Feb 13.
PubMed 32061318Orgel E, Genkinger JM, Aggarwal D, Sung L, Nieder M, Ladas EJ. Association of body mass index and survival in pediatric leukemia: a meta-analysis. Am J Clin Nutr. 2016 Mar;103(3):808-17. doi: 10.3945/ajcn.115.124586. Epub 2016 Feb 10.
PubMed 26864366Ringwald-Smith K, Hill R, Evanoff L, Martin J, Sacks N. When Reality and Research Collide: Guidelines Are Essential for Optimal Nutrition Care in Pediatric Oncology. J Pediatr Hematol Oncol. 2022 Jan 1;44(1):e144-e151. doi: 10.1097/MPH.0000000000002200.
PubMed 34001795Fabozzi F, Trovato CM, Diamanti A, Mastronuzzi A, Zecca M, Tripodi SI, Masetti R, Leardini D, Muratore E, Barat V, Lezo A, De Lorenzo F, Caccialanza R, Pedrazzoli P. Management of Nutritional Needs in Pediatric Oncology: A Consensus Statement. Cancers (Basel). 2022 Jul 11;14(14):3378. doi: 10.3390/cancers14143378.
PubMed 35884438Tachibana H, Koga K, Fujimura Y, Yamada K. A receptor for green tea polyphenol EGCG. Nat Struct Mol Biol. 2004 Apr;11(4):380-1. doi: 10.1038/nsmb743. Epub 2004 Mar 14.
PubMed 15024383Garcia-Perdomo HA, Gomez-Ospina JC, Reis LO. Immunonutrition hope? Oral nutritional supplement on cancer treatment. Int J Clin Pract. 2021 Nov;75(11):e14625. doi: 10.1111/ijcp.14625. Epub 2021 Jul 19.
PubMed 34251725Palagyi A, Balane C, Shanthosh J, Jun M, Bhoo-Pathy N, Gadsden T, Canfell K, Jan S. Treatment abandonment in children with cancer: Does a sex difference exist? A systematic review and meta-analysis of evidence from low- and middle-income countries. Int J Cancer. 2021 Feb 15;148(4):895-904. doi: 10.1002/ijc.33279. Epub 2020 Sep 22.
PubMed 32875569Friedrich P, Lam CG, Itriago E, Perez R, Ribeiro RC, Arora RS. Magnitude of Treatment Abandonment in Childhood Cancer. PLoS One. 2015 Sep 30;10(9):e0135230. doi: 10.1371/journal.pone.0135230. eCollection 2015.
PubMed 26422208Gomez EV, Perez YM, Sanchez HV, Forment GR, Soler EA, Bertot LC, Garcia AY, del Rosario Abreu Vazquez M, Fabian LG. Antioxidant and immunomodulatory effects of Viusid in patients with chronic hepatitis C. World J Gastroenterol. 2010 Jun 7;16(21):2638-47. doi: 10.3748/wjg.v16.i21.2638.
PubMed 20518086
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Evaluate the Effect and Safety of the Use of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours
- ClinicalTrials.gov ID
- NCT06363201
- Acronym / sponsor ID
- CAT2024/PED01
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Lymphoma, Hodgkin, Central Nervous System Tumor, Sarcoma, Germ Cell Tumor
- Keywords
- Epigallocatechin gallate, Paediatric, Advanced Solid Tumor, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 12 Apr 2024 (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.
Exploratory study to evaluate the effect and safety of the use of Ocoxin® oral solution on the quality of life of paediatric patients with advanced stage solid tumours.
Detailed description
This is a prospective, open-label, single-centre, exploratory study in paediatric patients with advanced stage solid tumours receiving oncospecific therapy.
Ocoxin®: The research product, registered as a nutritional supplement (Ocoxin®, oral solution), manufactured by Catalysis S.L. of Spain. It comes in the form of 30 ml single-dose vials.
Forty paediatric patients will be included, distributed as follows: Hodgkin's lymphoma (10), Central Nervous System tumours (10), Sarcoma of any type (10) or Germinal Tumours (10).
Patients will receive one vial of Ocoxin® daily from the start of oncospecific therapy until two weeks after the end of therapy.
Prior to the start of treatment and before each cycle of QT, a haemogram and haemochemistry including albumin, total proteins, transaminases (TGO, TGP) will be performed. Physical examinations will be performed, and the patient's vital signs and body weight will be evaluated.
Prior to the start of treatment, in month three and four weeks after the end of oncospecific therapy, a CT scan will be performed (depending on the type of tumour, the system for evaluating the efficacy of the oncospecific treatment will be adapted).
Quality of life will be assessed using the paediatric quality of life questionnaire (PedsQLTm, version 4.0. Spanish). The questionnaire will be administered to the parent or guardian prior to the start of treatment, at month 3 and at the end of treatment with Ocoxin®. In the case of longer treatment regimens, intermediate quality of life measurements may be taken after the three months and before the end of treatment.
The influence of Ocoxin® Oral solution on the prevention of admissions due to toxicity attributable to cancer-specific therapy and changes in the patient's nutritional status will also be assessed.
Safety will be assessed by collecting adverse events (AEs), analytical parameters, physical examinations and vital signs.
Effect and safety variables will be summarised using descriptive statistics and frequency counts.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ocoxin Oral Solution | Experimental | Dietary Supplement: Ocoxin Oral solutionPatients will receive one vial of Ocoxin® daily from the start of oncospecific therapy until two weeks after the end of therapy. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patient of either sex in the paediatric age group, between 7 and 18 years of age.
- Father, mother or legal guardian who consents in writing to the minor's participation in the study. Written consent of the minor for ages 12 to 18 years. Verbal consent of the minor for ages 7 to 11 years.
- Histologically confirmed diagnosis of solid tumour of any location, in advanced stage, with criteria to receive oncospecific therapy.
- Patients with haematological parameters within normal figures that allow them to receive oncospecific therapy, according to the management protocols for each of the diseases.
Key exclusion criteria (3 listed)
- Pregnancy or breast-feeding (if less than 3 months have elapsed since delivery, abortion, or breast-feeding prior to the start of treatment).
- Hypersensitivity to any component of the product under study (Ocoxin®).
- Any disease or condition that could interfere with the interpretation of the results.
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 |
|---|---|---|
| Ocoxin Oral solutionPatients will receive one vial of Ocoxin® orally daily, preferably at the same time each day. The duration of treatment will depend on the chemotherapy schedule the patient will receive. Treatment with Ocoxin® will be from the start of oncospecific therapy until two weeks after the end of therapy. | Dietary supplement | Ocoxin Oral Solution |
Primary outcome
Quality of Life
Time frame: 7 months
Qualitative and quantitative data collection. To assess the effect of Ocoxin® on the quality of life of paediatric patients with advanced solid tumours by the Paediatric Quality of Life Questionnaire (PedsQLTm, version 4.0. Spanish). The questionnaire will be administered to the parent or guardian prior to the start of treatment, at month 3 and at the end of treatment with Ocoxin®. In the case of longer treatment regimens, intermediate quality of life measurements may be taken after the three-month treatment and before the end of treatment.
6 secondary outcomes
Degree of toxicity related to oncospecific treatment
Time frame: 7 months
Nutritional Status
Time frame: 7 months
Presence of Adverse Events (AE)
Time frame: 7 months
Metabolic Status
Time frame: 7 months
Physical Status
Time frame: 7 months
Response to oncospecific treatment
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Background: PubMed 28410997Steliarova-Foucher E, Colombet M, Ries LAG, Moreno F, Dolya A, Bray F, Hesseling P, Shin HY, Stiller CA; IICC-3 contributors. International incidence of childhood cancer, 2001-10: a population-based registry study. Lancet Oncol. 2017 Jun;18(6):719-731. doi: 10.1016/S1470-2045(17)30186-9. Epub 2017 Apr 11.
- Background: PubMed 30872518Lam CG, Howard SC, Bouffet E, Pritchard-Jones K. Science and health for all children with cancer. Science. 2019 Mar 15;363(6432):1182-1186. doi: 10.1126/science.aaw4892.
- Background: PubMed 21370414Gohar SF, Comito M, Price J, Marchese V. Feasibility and parent satisfaction of a physical therapy intervention program for children with acute lymphoblastic leukemia in the first 6 months of medical treatment. Pediatr Blood Cancer. 2011 May;56(5):799-804. doi: 10.1002/pbc.22713. Epub 2011 Jan 16.
- Background: PubMed 11468499Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
- Background: PubMed 9591169Varni JW, Katz ER, Seid M, Quiggins DJ, Friedman-Bender A, Castro CM. The Pediatric Cancer Quality of Life Inventory (PCQL). I. Instrument development, descriptive statistics, and cross-informant variance. J Behav Med. 1998 Apr;21(2):179-204. doi: 10.1023/a:1018779908502.
- Background: PubMed 11932914Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
- Background: PubMed 32061318Joffe L, Ladas EJ. Nutrition during childhood cancer treatment: current understanding and a path for future research. Lancet Child Adolesc Health. 2020 Jun;4(6):465-475. doi: 10.1016/S2352-4642(19)30407-9. Epub 2020 Feb 13.
- Background: PubMed 26864366Orgel E, Genkinger JM, Aggarwal D, Sung L, Nieder M, Ladas EJ. Association of body mass index and survival in pediatric leukemia: a meta-analysis. Am J Clin Nutr. 2016 Mar;103(3):808-17. doi: 10.3945/ajcn.115.124586. Epub 2016 Feb 10.
- Background: PubMed 34001795Ringwald-Smith K, Hill R, Evanoff L, Martin J, Sacks N. When Reality and Research Collide: Guidelines Are Essential for Optimal Nutrition Care in Pediatric Oncology. J Pediatr Hematol Oncol. 2022 Jan 1;44(1):e144-e151. doi: 10.1097/MPH.0000000000002200.
- Background: PubMed 35884438Fabozzi F, Trovato CM, Diamanti A, Mastronuzzi A, Zecca M, Tripodi SI, Masetti R, Leardini D, Muratore E, Barat V, Lezo A, De Lorenzo F, Caccialanza R, Pedrazzoli P. Management of Nutritional Needs in Pediatric Oncology: A Consensus Statement. Cancers (Basel). 2022 Jul 11;14(14):3378. doi: 10.3390/cancers14143378.
- Background: PubMed 15024383Tachibana H, Koga K, Fujimura Y, Yamada K. A receptor for green tea polyphenol EGCG. Nat Struct Mol Biol. 2004 Apr;11(4):380-1. doi: 10.1038/nsmb743. Epub 2004 Mar 14.
- Background: PubMed 34251725Garcia-Perdomo HA, Gomez-Ospina JC, Reis LO. Immunonutrition hope? Oral nutritional supplement on cancer treatment. Int J Clin Pract. 2021 Nov;75(11):e14625. doi: 10.1111/ijcp.14625. Epub 2021 Jul 19.
- Individual participant dataSharing planned: Yes
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocoxin Oral solution in people with Advanced Cancer and Advanced Solid Tumor, run by Catalysis SL at 1 site in Honduras.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingrid C. Arambu Elvir, Dr. (50498878486, ingridcarolinaa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 7 months). 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 NCT06363201, which also lists 25 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 12 Apr 2024.