Vitamin E/ Platinum salts

Phase 3

Conditions: Peripheral Neuropathy

Registration Number: RPCEC00000195

Lead Sponsor: Drug Research and Development Center CIDEM)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 200

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>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 Measures