Comparison of Duloxetine Versus Pregabalin

Phase 2

• Conditions: Drug Effect
• Interventions: Drug: Duloxetine; Drug: Pregablin

• Registration Number: NCT04727502
• Lead Sponsor: National Cancer Institute, Egypt

Brief Summary

Chronic post mastectomy pain syndrome (PMPS) is a chronic post-surgical neuropathic pain following breast cancer surgeries and lasting more than three months after surgeries. Pregabalin is originally used as an antiepileptic drug and identified as treatment for neuropathic pain .There are several recent reviews have revealed that it reduces post-operative opioid consumption and improves pain scores after breast surgeries. Duloxetine is a serotonin and norepinephrine reuptake inhibitor. Its mechanism of action is related to the potentiation of serotonergic and noradrenergic activity in the descending inhibitory pain pathways of the central nervous system and used for treatment of neuropathic pain conditions as painful diabetic neuropathy, neuropathic pain of lung cancer and chemotherapy induced sensory neuropathy

Detailed Description

Patients with of 3 months of chronic neuropathic pain after breast surgery (either modified radical mastectomy or conservative breast surgery) combined with axillary dissection is considered as post mastectomy pain syndrome which is defined as pain involving the anterior aspect of the chest, axilla, and/or upper arm with the classical features of neuropathic pain including numbness, tingling, burning, shooting, stinging, or stabbing pains, and hyperesthesia.

* They are divided to 2 equal groups: ( Group A) receive duloxetine for 12 weeks and (Group B) control group receive pregabalin for 12 weeks .

* Dosing and administration Group A) Duloxetine 30 mg /day at bed time and (Group B) control group Pregablin 150mg /day( 75 mg /12 hours )

* Randomization and blinding: Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope.

* Concomitant therapy :opioid therapy according to WHO step ladder in cancer pain

Study Timeline

• Study Start: 2020-12-20
• Study First Submitted: 2020-12-25
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-26
• Last Update Submitted: 2021-01-26
• Study First Posted: 2021-01-27
• Last Update Posted: 2021-01-27
• Primary Completion: 2021-03
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Female, history of breast surgery and patients with post mastectomy pain

Exclusion Criteria

• pregnancy,history of allergy to Pregabalin or duloxetine, pregnancy or lactation, history of pregabalin or gabapentin intake in the preceding three months, history of radiotherapy and history of drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
( Group Duloxetine )	Duloxetine	• Dosing and administration (Group A) Duloxetine 30 mg /day oral intake at bed time
(Group Pregablin )	Pregablin	control group Pregablin 150mg /day( 75 mg /12 hours ) oral intake.

Primary Outcome Measures

Name	Time	Method
visual analogue score	baseline till 12 weeks of treatment	visual analogue score with least pain score is 0 and worst pain is 10

Trial Locations

Locations (1)

Nataional Cancer Instituite; 🇪🇬 Cairo, Egypt