Oncoxin-Viusid / Pancreatic adenocarcinoma / Adults / Phase II

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of the effect of the nutritional supplement Oncoxin®-Viusid® on the quality of life of patients with advanced pancreatic adenocarcinoma. Phase II.

Secondary indentifying numbers:

CAT-2018-1

Issuing authority of the secondary identifying numbers:

National Coordinator Center of Clinical Trials (CENCEC)

Source(s) of monetary or material support:

Laboratories Catalysis, S.A

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Trials notification

Regulatory instance:

Institute of Nutrition and Hygiene of food(INHA)

Notification date :

02/07/2018

Reference number:

Not Applicable

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Jorge

Midle name:

Luis

Last name:

Soriano Garcia

Medical Specialty :

2nd grade specialist in Clinical Oncology

Affiliation:

"Hermanos Ameijeiras" Surgical Clinical Hospital

Postal address:

San Lazaro esq. Belascoain, Centro Habana.

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-78761926

Email address:

soriano@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not Applicable

Research ethics committees:

Hermanos Ameijeiras Hospital, April 12th, 2018

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

10/09/2018

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Pancreatic cancer

Health condition(s) code:

Pancreatic Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Digestive System Diseases

Endocrine System Diseases

Intervention(s):

Oncoxin-Viusid group (Experimental). Oral solution of Oncoxin-Viusid (vials of 30 ml), at a rate of 60 ml daily (1 vial every 12 hours), preferably administered after breakfast and dinner. The treatment will have a period of a year and, it will start 2 weeks before the onco-specific treatment. The treatment with Oncoxin-Viusid will continue in the possible periods of time of suspension of the chemotherapy treatment due to toxicities attributable to the onco-specific treatment.

Intervention code:

Dietary Supplements

Administration, Oral

Intervention keyword:

Oncoxin viusid

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Quality of life (General Quality of Life EORTC QLQ-C30). Measurement time: at baseline and, 3, 6, 9, 12 months.

Key secondary outcomes:

Related to the efect: 1. Compliance with the treatment with chemotherapy (CT) and Immunotherapy (IT) in time and the doses are planned (Data related to administration or not of the CT/IT in the planned time, number of the cycle administered out of date, Days elapsed since the previous cycle and, cause that caused the administration of the CT/IT outside the planned date. In the case of the dose, the medication in which it was modified will be taken into account, as well as the modified dose). Measurement time: During the time of the CT/IT concurrent, and then, during the time of it. 2. Nutritional status (Body Mass Index). Measurement time: At baseline and, 3, 6, 9 and, 12 months Related to the Safety 3. Adverse Events-AE (Occurrence of an AE in the subject [Yes, No]; Description of the AE [Name of the event]; Duration of the AE [Difference between the start and end date of the event]; Intensity of the AE [According to CTCAE version 4 it will classify in Light, Moderate, Severe, Life-threatening consequences, Death related to AE]; Seriousness of the AE [serious or not serious], Attitude with respect to the treatment under study [No changes, dose modification, temporary or definitive interruption of the study treatment], Result of the AE [recovered, improved, persisted or sequelae], Causal relationship [According to WHO algorithm it will classify in very probable, probable, possible, improbable, unrelated, not evaluable]). Measurement time: 3, 6, 9, 12 months. 4. Hematology tests (Hemoglobin, Platelets, Hemogram with differential). Measurement time: at baseline and, 3, 6, 9, 12 months. 5. Blood Chemistry tests (GPT, GOT, Creatinine, Glycemia, Bilirrubin, Alkaline Phosphatase, LDH). Measurement time: at baseline and, 3, 6, 9, 12 months.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1- Patients of any sex, resident in Cuba, with an age greater than or equal to 18 years. 2- Patients that meet the diagnostic criteria. 3- Patients with general health according to Karnofsky ≥70%. 4- Life expectancy greater than or equal to 3 months. 5- Patients eligible to receive chemotherapy. 6- Patients who have signed the informed consent. 7- Patients who have laboratory values in parameters that do not contraindicate the administration of chemotherapy: Hemoglobin ≥ 90 g/l, Total Leukocyte Count ≥ 3.0 x 109 / L, Absolute Neutrophil Count ≥1.5 x 109 / L. o Platelet count ≥100 x 109 / L, Total bilirubin values ≤ 1.5 times the upper limit of the normal range established in the institution, TGO and TGP values ≤2.5 times the upper limit of the normal interval established in the institution and, Creatinine values within the normal limits of the institution.

Exclusion criteria:

1- Patients who are receiving another product under investigation. 2- Patients with known hypersensitivity to any of the active ingredients of the chemotherapy used 3- Patients with decompensated intercurrent diseases, including: HBP, Diabetes Mellitus, Ischemic Heart Disease, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage or any other special condition that at the discretion of the doctor puts their health at risk and his life during the study or his participation in the trial. 4-Patients who are pregnant or breastfeeding. 5- Patients with mental disorders that could limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up. 6- Patients with brain metastases.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

2

Target sample size:

30

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Ivis

Last Name:

Mendoza Hernandez

Specialty:

Bachelor degree in Pharmaceutical Sciences. Master of Science in Pharmacology

Affiliation:

National Coordinator Center of Clinical Trials (CENCEC)

Postal Address:

5th street A between 60 and 62. Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72164227

Email :

ivis@cencec.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Mayte

Middle Name:

Last Name:

Lima Perez

Specialty:

2nd grade specialist in Clinical Oncology

Affiliation:

Hermanos Ameijeira Hospital

Postal Address:

San Lazaro esq. Belascoain, Centro Habana.

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-78761434

Email :

mayte.lima@infomed.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000281

Date of Registration in Primary Registry:

01/08/2018

Record Verification Date:

2018/08/01

Next update date:

2019/08/01

Link to the spanish version:

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Registered Trials

Registration process

Oncoxin-Viusid / Pancreatic adenocarcinoma / Adults / Phase II

About the RPCEC

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