Vitamin E/ Platinum salts

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:

EFFICACY OF VITAMIN E ON THE PREVENTION OF PERIPHERAL NEUROPATHY INDUCED BY CHEMOTHERAPY WITH CISPLATIN AND OXALIPLATIN

Acronym of Scientific Title:

CIN-Vit E

Secondary indentifying numbers:

EC-00113

Issuing authority of the secondary identifying numbers:

Drug Research and Development Center (CIDEM)

Source(s) of monetary or material support:

Drug Research and Development Center CIDEM)

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:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

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

First name:

Roberto

Last name:

Leon Castellon

Medical Specialty :

MD. First Degree Specialist in Neurology

Affiliation:

“Hermanos Ameijeiras” Clinical-Surgical Hospital.

Postal address:

Calle San Lázaro #701, Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78810892

Email address:

robertoleonc@infomed.sld.cu [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

Clinical sites:

Not applicable

Research ethics committees:

“Hermanos Ameijeiras” Clinical-Surgical Hospital, Havana, May 2th, 2013.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

12/01/2016

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:

Peripheral Neuropathy

Intervention(s):

Group A (Study group): Vitamin E. Single daily dose of 300mg, orally, beginning three days before starting the first cycle of chemotherapy (CMT)and concluding three months after the last cycle of CMT Group B (Control group): Placebo will be administered using the same frequency and route of administration during the same period.

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):

Clinical evaluation of the induction of sensory and motor neuropathy (Presence or not of affectation in superficial sensitivity, profound sensitivity, muscle strength, tendon reflexes and autonomic symptoms) Measuring time: Baseline; after the 4th treatment cycle with chemotherapy (CMT); 3 months after the last cycle of CM). Electrophysiological evaluation of the induction of sensory and motor neuropathy (Changes in Sensory nerve potential of action; Compose muscular potential of action, Sensory nerve conduction speed; Motor nerve conduction speed). Measuring time: Baseline; after the 4th treatment cycle with CMT; 3 months after the last cycle of CMT).

Key secondary outcomes:

Cumulative dose of cisplatin and oxaliplatin (Sum of the administered doses). Measuring time: after the 4th treatment cycle with CMT; 3 months after the last cycle of CMT). Efficacy of chemotherapy (Response to CMT in favorable: when the response RECIST as Complete Response (CR) or Partial Response (PR) to target lesions and Complete Response (CR) or No Complete Remission / No Disease Progression (No-CR / No-PD) to non-target lesions. unfavorable: when the response RECIST as Stable Disease (SD) or Progression Disease (PD) to target lesions and Progression Disease (PD) to non-target lesions by RECIST version 1.1). Measuring time: after the last cycle of CMT. Grade of Peripheral Nerve Toxicity (Grades 1 - 5 According to NCI-CTC v 4.03) Measuring time: after the 4th treatment cycle with CMT; 3 months after the last cycle of CMT). Presence of clinical adverse events (AE) (distribution frequency for the appearance of adverse events (Yes, No), type of event (name of the AE), duration (time between beginning and end of the event), intensity of AE (mild, moderate, severe), relation of causality (remote, possible, probable, very probable), result of AE (recuperate, improvement, persist or sequels), attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation). Measuring time: every month until 3 months after the last cycle of CMT.

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:

70 years

Inclusion criteria:

1. Patients with lung, breast, gastrointestinal or head and neck neoplasia, tributary of treatment with cisplatin or oxaliplatin. 2. Patients without clinical or electrophysiological diagnosis of peripheral neuropathy at the time of entry. 3. Subjects of both gender, ranged between 19 and 70 years (both inclusive). 4. Patient’s written, informed consent.

Exclusion criteria:

1. Antecedents or clinical evidence of the following pathologies: Some previous type of peripheral neuropathy, family story of any type of inherited-familiar neuropathy. 2. Patients who have received prior chemotherapy. 3. Patients who have received drugs that can produce peripheral nerve damage. 4. Severe acute diseases at the time of entry. 5. Diabetes Mellitus 6. Patients receiving treatment with Amifostine, acetyl L carnitine, Glutanine, erythropoietin and infusions of Ca and Mg. 7. Hypersensitivity to the active substance (Vitamin E) or some of the inactive substances that are present in the formulation. 8. Concurrent participation in another clinical trial.

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:

Prevention

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

200

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:

Daise

Last Name:

Jimenez Rodriguez

Specialty:

Bachelor in Pharmaceutical Services

Affiliation:

Drug Research and Development Center CIDEM)

Postal Address:

Ave 26 # 1605. Nuevo Vedado.

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+537-881-1944

Email :

daise.jimenez@cidem.sld.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:

Daise

Last Name:

Jimenez Rodríguez

Specialty:

Bachelor in Pharmaceutical Services

Affiliation:

Drug Research and Development Center CIDEM)

Postal Address:

Ave 26 # 1605. Nuevo Vedado.

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+537 881 1944

Email :

daise.jimenez@cidem.sld.cu [2]

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:

RPCEC00000195

Date of Registration in Primary Registry:

12/05/2015

Record Verification Date:

2015/05/12

Next update date:

2016/05/12

Link to the spanish version:

Click here [3]