Vidatox 30CH in advanced malignant tumors-Primary health care-Phase IV

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:

Effectiveness and safety of Vidatox® 30CH over the quality of life of patients with advanced malignant tumors

Secondary indentifying numbers:

VIDATOX® 30CH-Primary health care-01-2012

Issuing authority of the secondary identifying numbers:

Enterprise Group LABIOFAM

Source(s) of monetary or material support:

Enterprise Group of Biopharmaceutic and Chemical Productions LABIOFAM Cuban Ministery of Public Health

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Dr. Eva Salomon Zaldívar, First degree specialist in Oncology, Observatory of Cancer Coordinator

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

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

Research ethics committees:

Dr. Luis Diaz Soto Military Hospital, September 28th 2012 Centralized Ethic Committee Province Health , October 14th 2012

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

21/05/2013

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:

Advanced malignant tumors

Intervention(s):

Every patient included will be prescribed with 5 sublingual drops of Vidatox 30CH homeopathic drug, 3 times per day during 6 months. After 6 months of treatment their quality of life will be evaluated and treatment will change or not depending on it - Patients with improved quality of life will be prescribed 5 sublingual drops of Vidatox 30CH homeopathic drug, 2 times per day to complete 1 year of treatment. - All the other patients will keep same squeme of treatment as before, 5 sublingual drops of Vidatox 30CH homeopathic drug, 3 times per day to complete 1 year of treatment.

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 (EORTC QLQ-C30 quality of life questionnaire). Measuring time: at baseline and monthly until 12 months of treatment.

Key secondary outcomes:

Adverse events (AE). Measuring time: Monthly until 12 months of treatment. -Description of AE (Name of the event) -Duration of AE (Difference between the beginning date and the finish date of the event) -Intensity of AE (Light , Moderate, Severe) -Severity of AE (Severe/Serious,Not severe/Not serious) -Attitude to study treatment (Unchanged,Dose modification ,Temporary discontinuation of study treatment,Permanent discontinuation of study treatment) -Outcome of AE (Recovered,Improved,Persist,Persist,Sequelae) -Relationship causality (Definitive,Very likely,Probable,Possible,Not related,Unknown)

Selection criterias

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

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

N/A (No limit)

Inclusion criteria:

Patients with histological diagnose of malignant tumors in IIIb and IV stages 19 years old or older patients Patients capable to anwser questionaries Patients with written consens to participate in the study

Exclusion criteria:

Pregnancy or breast feeding Patients included in another clinical trial Patients treated with Vidatox® 30CH one month before starting the study

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:

Target sample size:

1012

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:

Carmen

Middle Name:

Inés

Last Name:

Morales Paneque

Affiliation:

Clinical Trials Division, Enterprise Group LABIOFAM

Postal Address:

1st St & B, Palco Siboney Inmobiliary Building, Vedado

City:

La Habana

País:

Cuba

Zip Code:

10400

Telephone:

+537-8303276

Email :

carmen.morales@labnet.com.cu [2]

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:

Carmen

Middle Name:

Inés

Last Name:

Morales Paneque

Affiliation:

Clinical Trials Division, Enterprise Group LABIOFAM

Postal Address:

1st St & B, Palco Siboney Inmobiliary Building, Vedado

City:

La Habana

País:

Cuba

Zip Code:

10400

Telephone:

+537-8303276

Email :

carmen.morales@infomed.sld.cu [3]

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:

RPCEC00000153

Date of Registration in Primary Registry:

2013-05-21

Record Verification Date:

2013-05-03

Next update date:

2014-05-03

Link to the spanish version:

Click here [4]