Vitamin E/ Platinum salts

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000195
• Date of registration: 12/05/2015
• Prospective Registration: Yes
• Primary sponsor: Drug Research and Development Center CIDEM)
• Public title: Vitamin E/ Platinum salts
• Scientific title: EFFICACY OF VITAMIN E ON THE PREVENTION OF PERIPHERAL NEUROPATHY INDUCED BY CHEMOTHERAPY WITH CISPLATIN AND OXALIPLATIN - CIN-Vit E
• Date of first enrolment: 12/01/2016
• Target sample size: 200
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000195-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Prevention
• Phase: 3

Countries of recruitment

Cuba

Contacts

• Name: Daise Jimenez Rodriguez
• Affiliation: Drug Research and Development Center CIDEM)

• Name: Daise Jimenez Rodríguez
• Affiliation: Drug Research and Development Center CIDEM)

Key inclusion & exclusion criteria

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.

Age minimum: 19 years
Age maximum: 70 years
Gender: Male/Female

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.

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).

Secondary Outcome(s)

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.

Secondary ID(s)

EC-00113

Source(s) of Monetary Support

Drug Research and Development Center CIDEM)

Secondary Sponsor(s)

Not applicable