Cutaneous Melanoma, Stage IIPhase 2NCT03541148
Evaluation of Oncoxin-Viusid® in Cutaneous Melanoma
A Phase 2 study testing Oncoxin-Viusid in people with Cutaneous Melanoma, Stage II and Malignant Cutaneous Melanoma, run by Catalysis SL at 1 site in Cuba.
Trial summary
Malignant melanoma, responsible for 75% of deaths from skin cancer. Current therapeutic options have poor response, many adverse events and high costs. For this reason, a study with nutritional supplement Oncoxin-Viusid was carried out. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Melanoma, Stage II, Malignant Cutaneous Melanoma, Cutaneous Melanoma, Stage III
- What is being tested?
- Oncoxin-Viusid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCuba
- Study dates
- 16 Sep 2014to 13 Apr 2018
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with histological diagnosis of Malignant Cutaneous Melanoma in stage IIB-IIC-IIIA
- Subjects of 18 years and over of both sexes.
- General health status according to the Karnofsky Index ≥ 70.
- Laboratory parameters within the normal limits defined as: Hematopoietic: Hemoglobin ≥ 9 g / L, Total Leukocytes ≥ 3 x 109 cells / L, Neutrophils ≥ 1.5 x 109 cells / L, Platelets ≥ 100 x 109 / L Hepatic: Liver function within 2.5 times upper normal limit and without liver disease demonstrated by TGP, OGT and alkaline phosphatase.
- Patients who express written voluntariness to enter the study with their signature of the informed consent document.
- Women of childbearing age should have a negative pregnancy test and use effective contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation.
Who cannot join
- Pregnancy or lactation.
- Patients with a second concomitant tumor.
- Present an associated chronic disease in the decompensation phase (heart disease, diabetes, hypertension).
- History of hypersensitivity to another similar product.
- Severe acute allergic states.
- Severe septic processes.
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- Non-operated patients, in whom the surgery was contraindicated.
- Patients at potential risk of not completing the study (those who will travel during the period of the investigation or distance in their residence, outside the city).
- Subjects who are participating in another clinical trial.
- Patients with cognitive disorders or a mental disorder that hinders their follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Nutritional Supplement Oncoxin-Viusid® in the Treatment of 20 Patients With Cutaneous Melanoma in Stage IIB-IIIA
Malignant melanoma, responsible for 75% of deaths from skin cancer. Current therapeutic options have poor response, many adverse events and high costs. For this reason, a study with nutritional supplement Oncoxin-Viusid was carried out. According to previous studies, it has an antitumor, immunomodulatory effect and to potentiate the antiproliferative effect of standard chemotherapeutic agents in different locations and stages of cancer.
Read the detailed description
Performed at Manuel Fajardo Surgical Clinical University Hospital in Havana, Cuba from September 2014 to April 2018, following a proof of concept open label study, with no control group in 20 patients diagnosed histologically in Fajardo Hospital or Oncology Institute, as Melanoma, primary cutaneous stage IIB-IIIA. All received conventional surgical treatment and oral Oncoxin-Viusid (25 ml 2 times a day for one year), where it was also indicated adjuvant treatment or chemotherapy. All were evaluated monthly the first year and semesterly the second year. Complying with the provisions of the Helsinki Act.
- Being tested
- Oncoxin-Viusid
- Keywords
- Cutaneous malignant melanoma, Nutritional supplement, survival, Green tea
- Medical subject headings
- Melanoma, Melanoma, Cutaneous Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncoxin-ViusidDietary supplement
Oncoxin-Viusid supplement before/during/after standard surgical and adjuvant treatment or chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Oncoxin-Viusid | Experimental | Nutritional supplement Oncoxin-Viusid 25 mL in oral solution twice a day Receives: Dietary Supplement: Oncoxin-Viusid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Calculated according to the method of Kaplan Meyer
Measured: 2 years
Disease free survival rate
Calculated according to the Kaplan Meyer method
Measured: 2 years
Secondary outcomes (4)
Temporary interruption of conventional treatment
Due to adverse events
Measured: 2 years
Presence of adverse events
Associated with conventional treatment
Measured: 2 years
Type of adverse events
According to severity and causality
Measured: 2 years
Quality of life
Quality of life questionnaire of the EORTC: QLQ30
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start16 Sep 2014
- Primary completion13 Apr 2016
- Study completion13 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Melanoma, Stage IIStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olaine R. Gray Lovio, Dr., Principal investigator, Manuel Fajardo Clinical Surgical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541148
- Sponsor's protocol ID
- OOS-CANCER-2
- Status last verified
- May 2018
- First submitted
- 3 May 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Nutritional Supplement Oncoxin-Viusid® in the Treatment of 20 Patients With Cutaneous Melanoma in Stage IIB-IIIA
- ClinicalTrials.gov ID
- NCT03541148
- Acronym / sponsor ID
- OOS-CANCER-2
- Keywords
- Cutaneous malignant melanoma, Nutritional supplement, survival, Green tea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2014 (actual)
- Primary completion
- 13 Apr 2016 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 30 May 2018 (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.
Malignant melanoma, responsible for 75% of deaths from skin cancer. Current therapeutic options have poor response, many adverse events and high costs. For this reason, a study with nutritional supplement Oncoxin-Viusid was carried out. According to previous studies, it has an antitumor, immunomodulatory effect and to potentiate the antiproliferative effect of standard chemotherapeutic agents in different locations and stages of cancer.
Detailed description
Performed at Manuel Fajardo Surgical Clinical University Hospital in Havana, Cuba from September 2014 to April 2018, following a proof of concept open label study, with no control group in 20 patients diagnosed histologically in Fajardo Hospital or Oncology Institute, as Melanoma, primary cutaneous stage IIB-IIIA. All received conventional surgical treatment and oral Oncoxin-Viusid (25 ml 2 times a day for one year), where it was also indicated adjuvant treatment or chemotherapy. All were evaluated monthly the first year and semesterly the second year. Complying with the provisions of the Helsinki Act.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncoxin-Viusid | Experimental | Dietary Supplement: Oncoxin-ViusidNutritional supplement Oncoxin-Viusid 25 mL in oral solution twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histological diagnosis of Malignant Cutaneous Melanoma in stage IIB-IIC-IIIA
- Subjects of 18 years and over of both sexes.
- General health status according to the Karnofsky Index ≥ 70.
- Laboratory parameters within the normal limits defined as: Hematopoietic: Hemoglobin ≥ 9 g / L, Total Leukocytes ≥ 3 x 109 cells / L, Neutrophils ≥ 1.5 x 109 cells / L, Platelets ≥ 100 x 109 / L Hepatic: Liver function within 2.5 times upper normal limit and without liver disease demonstrated by TGP, OGT and alkaline phosphatase.
- Patients who express written voluntariness to enter the study with their signature of the informed consent document.
Key exclusion criteria (10 listed)
- Pregnancy or lactation.
- Patients with a second concomitant tumor.
- Present an associated chronic disease in the decompensation phase (heart disease, diabetes, hypertension).
- History of hypersensitivity to another similar product.
- Severe acute allergic states.
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 |
|---|---|---|
| Oncoxin-ViusidOncoxin-Viusid supplement before/during/after standard surgical and adjuvant treatment or chemotherapy. | Dietary supplement | Oncoxin-Viusid |
Primary outcome
Overall survival rate
Time frame: 2 years
Calculated according to the method of Kaplan Meyer
Disease free survival rate
Time frame: 2 years
Calculated according to the Kaplan Meyer method
4 secondary outcomes
Temporary interruption of conventional treatment
Time frame: 2 years
Presence of adverse events
Time frame: 2 years
Type of adverse events
Time frame: 2 years
Quality of life
Time frame: 2 years
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 30 May 2018.
- Individual participant dataSharing planned: Yes
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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.
Olaine R. Gray Lovio, Dr. principal investigator
Manuel Fajardo Clinical Surgical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oncoxin-Viusid in people with Cutaneous Melanoma, Stage II and Malignant Cutaneous Melanoma, run by Catalysis SL at 1 site in Cuba.
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 6 inclusion and 10 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 30 May 2018. 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 Cuba. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Overall survival rate (time frame: 2 years). 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?
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 30 May 2018.