Peripheral Neuropathy
Conditions
Interventions
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
Sponsors
Drug Research and Development Center CIDEM)
Eligibility
Sex/Gender
All
Age
19 Years to 70 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Cuba
Contacts
Public ContactDaise Jimenez Rodriguez
Drug Research and Development Center CIDEM)
Outcome results
None listed