Clinical trial NCT00380874: Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Of The Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy Symptoms In Subjects With Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chemotherapy-Induced Peripheral Neuropathy
Keywords: Pain
chemotherapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS)
timeFrame: Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)
Secondary outcomes:
measure: Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
timeFrame: Baseline to Cycle 9
measure: Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
timeFrame: Baseline to Cycle 9, LOCF cycle endpoint
measure: Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
timeFrame: Baseline to Cycle 9, LOCF cycle endpoint
measure: Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle
timeFrame: Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint
measure: Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
timeFrame: Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint
Other outcomes:
Locations:
city: St. Leonards
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Bielefeld
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Hamm
country: Germany
facility: Pfizer Investigational Site
city: Chieti Scalo
country: Italy
facility: Pfizer Investigational Site
city: Potenza
country: Italy
facility: Pfizer Investigational Site
city: Goyang-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Santander
country: Spain
facility: Pfizer Investigational Site
state: Cantabria
city: Alicante
country: Spain
facility: Pfizer Investigational Site
city: Jaen
country: Spain
facility: Pfizer Investigational Site
city: Niao-Sung Hsiang
country: Taiwan
facility: Pfizer Investigational Site
state: Kaohsiung Hsien
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: