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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chemotherapy-Induced Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

flexible dosing

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No