Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer

Viatris

Status and phase: Terminated; Phase 4

Conditions: Chemotherapy-Induced Peripheral Neuropathy

Treatments: Drug: Placebo; Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380874

A0081124

Details and patient eligibility

About

Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy.

Full description

This study was terminated on July 15, 2008. The results of an interim analysis showed that the conditional power to detect a difference in treatment groups was insufficient to warrant study continuation and therefore termination of the trial was recommended. The decision to terminate the trial was not based on safety concerns.

Enrollment: 64 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of cytological confirmed carcinoma of the Colon Stage III (Dukes C) or metastatic Colorectal Cancer (Dukes D)
• Independent of this protocol, the patient has decided to receive standard of care for the treatment of cancer with oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA) for a minimum of 9 cycles

Exclusion criteria

• Presence of neuropathic pain or peripheral polyneuropathy or identified causes of painful paresthesia including radiotherapy-induced or malignant plexopathy, lumbar or cervical radiculopathy existing prior to baseline
• Any patients who are not suitable to be treated with either Oxaliplatin and/or 5-FU/FA or pregabalin according to the respective local labeling

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

flexible dosing

Treatment:

Drug: Pregabalin

2

Placebo Comparator group

Treatment:

Drug: Placebo