Vitamin E/ Platinum salts

Phase 3

Not yet recruiting

• Conditions: Peripheral Neuropathy

• Registration Number: RPCEC00000195
• Lead Sponsor: Drug Research and Development Center CIDEM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-12
• Last Update Posted: 2024-08-19

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