Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel

Pain Clinical Trial

Official title:

RC11C3, Pilot Placebo-Controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02166385
• Other study ID #: RC11C3
• Secondary ID: NCI-2011-0364611
• Status: Active, not recruiting
• Phase: N/A
• First received: June 16, 2014
• Last updated: April 18, 2016
• Start date: January 2012

Study information

• Verified date: April 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This randomized pilot clinical trial studies pregabalin in preventing acute pain syndrome in patients receiving paclitaxel. Pregabalin may control the pain caused by cancer treatment.

Description:

PRIMARY OBJECTIVES:

I. To obtain pilot data regarding the possible effect of pregabalin on pain related to paclitaxel-associated acute pain syndrome (P-APS).

SECONDARY OBJECTIVES:

I. To obtain pilot data regarding the possible effect of pregabalin on paclitaxel-induced peripheral neuropathy.

II. To obtain pilot data regarding the possible relative toxicities related to pregabalin therapy in this study situation.

TERTIARY OBJECTIVES:

I. To characterize neurological testing abnormalities that might occur with the P-APS, and to evaluate neurological testing abnormalities during the period of the longer-term chemotherapy-induced peripheral neuropathy (CIPN).

II. To determine the patient-reported outcomes (PRO) incidence and characteristics of, and change in, P-APS and paclitaxel induced more chronic CIPN over several cycles.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive pregabalin orally (PO) twice daily (BID), beginning on the first night of chemotherapy, for 12 weeks and then once daily (QD) for 1 week.

ARM II: Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.

After completion of study treatment, patients are followed up every 30 days for 6 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to complete questionnaires by themselves or with assistance

• Paclitaxel at a dose of 80 mg/m^2 given, in the adjuvant (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for poly ADP ribose polymerase (PARP) inhibitors)

• Life expectancy > 6 months

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only (per clinician discretion)

Exclusion Criteria:

• Any of the following:

• Pregnant women

• Nursing women

• Men or women of childbearing potential who are unwilling to employ adequate contraception

• Previous diagnosis of diabetic or other peripheral neuropathy

• Current, planned, or previous use, within last 6 months, of gabapentin, pregabalin, or a PARP inhibitor, other than prescribed by this study

• History of allergic or other adverse reactions to gabapentin or pregabalin

• Significant renal insufficiency with a history of a creatinine clearance (CrCL) < 30ml/min

• Prior exposure to neurotoxic chemotherapy

• Seizure history

• Diagnosis of fibromyalgia

• Previous exposure to paclitaxel

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Pain
• Pain
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Drug:
• pregabalin
Given PO
• placebo
Given PO

Other:
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum of the worst pain scores for each treatment arm	The primary analysis will be to estimate means and 95% confidence intervals (CIs) for the maximum of the worst pain scores for cycle 1, for each treatment arm. The difference between the pregabalin and placebo arms will be compared in an exploratory fashion to determine if the difference, if any, is clinically meaningful and important, and worthy of further studies.	Up to Day 7	No
Primary	Maximum of the average pain score	Measured on a scale of 0 (no aches or pains) to 10 (aches or pains as bad as can be) using the daily post-paclitaxel questionnaire. Means and 95% CIs will be estimated.	Up to Day 7	No
Primary	Area under the curve (AUC) of worst, average and least pain	Measured on a scale of 0 (no aches or pains) to 10 (aches or pains as bad as can be) using the daily post-paclitaxel questionnaire. Means and 95% CIs will be estimated.	Up to Day 7	No
Primary	Proportion of patients who use non-prescription pain medications	According to the acute pain syndrome symptom summary questionnaire. Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Up to Day 7	No
Primary	Proportion of patients who use opioids	According to the acute pain syndrome symptom summary questionnaire. Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Up to Day 7	No
Primary	Proportion of patients who report the development of new aches/pains that they attribute to paclitaxel	According to the acute pain syndrome symptom summary questionnaire. Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Day 8	No
Secondary	Subscales of the European Organization for Research and Treatment of Cancer (EORTC) chemotherapy induced peripheral neuropathy (CIPN)-20 (motor, sensory, and autonomic)	Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Up to 6 months	No
Secondary	Individual items of the EORTC CIPN-20 instrument	Measured on a scale of 0 (no numbness, tingling, or pains) to 10 (numbness, tingling, or pains as bad as can be) using the acute pain syndrome symptom summary questionnaire. Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Up to 6 months	No
Secondary	Maximum of each EORTC CIPN-20 variable	Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Up to 6 months	No
Secondary	AUC of each EORTC CIPN-20 variable	Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Up to 6 months	No
Secondary	The worst pain scores in the first cycle of therapy and the subsequent neuropathy scores	Measured on a scale of 0 (no aches or pains) to 10 (aches or pains as bad as can be) using the daily post-paclitaxel questionnaire and the acute pain syndrome symptom summary questionnaire. Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Up to week 12	No
Secondary	Individual items from the monthly follow-up questionnaire	According to the daily post-paclitaxel questionnaire. Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Up to 6 months	No
Secondary	Average of each Symptom Summary question per cycle	Measured on a scale of 0 (not at all) to 10 (as bad as it can be) according to the acute pain syndrome symptom summary questionnaire. Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Up to week 12	No
Secondary	Maximum grade of peripheral neuropathy	According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Up to week 12	Yes
Secondary	Maximum grade of peripheral neuropathy with EORTC CIPN-20 variables and subscales and individual questions from the symptom summary	According to the NCI CTCAE version 4.0. Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Up to week 12	Yes
Secondary	Incidence of neurological abnormalities	Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Up to week 12	No
Secondary	Incidence of CIPN symptom development in regard to changes in nerve function tests	Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Up to week 12	No
Secondary	Changes over time of EORTC CIPN-20 subscales and nerve function tests	Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Baseline and prior to each course of paclitaxel up to week 12	No
Secondary	Nerve function test results	Means and 95% CIs will be estimated. Frequency counts and percentage will be produced.	Up to week 12	No