Comparison of Duloxetine Versus Pregabalin

National Cancer Institute, Egypt

Status and phase: Unknown; Phase 2

Conditions: Drug Effect

Treatments: Drug: Duloxetine; Drug: Pregablin

Study type: Interventional

Funder types: Other

Identifiers

NCT04727502

AP2007-50104

Details and patient eligibility

About

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

Full 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

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

( Group Duloxetine )

Active Comparator group

Description:

• Dosing and administration (Group A) Duloxetine 30 mg /day oral intake at bed time

Treatment:

Drug: Duloxetine

(Group Pregablin )

Active Comparator group

Description:

control group Pregablin 150mg /day( 75 mg /12 hours ) oral intake.

Treatment:

Drug: Pregablin