Efficacy of Duloxetine in Conjunction With Tramadol for Chronic Cancer Pain

NCT05311774 | Completed

• 1 other identifier: Duloxetine in cancer pain
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer pain is one of the most common and problematic symptoms. Opioids are typically the most common drugs used in the treatment of cancer pain,they are limited due to their side effects. Tramadol is a centrally acting non-opiate analgesic with low affinity for μ-opioid receptors, and is effective in the treatment of moderate to severe pain. Neuropathic pain is typically not amenable to standard opiate therapy, and the addition of tricyclic antidepressants or/and antiepileptic drugs can offer a very effective treatment strategy in such patients. Duloxetine is a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) that has been used traditionally for its antidepressant qualities and has also analgesic benefit in the treatment of neuropathic pain. Duloxetine exerts its analgesic action through central and peripheral pain modulation .

Conditions

Cancer Pain

Keywords

duloxetine; tramadol; cancer pain

Outcome Measures

Primary Outcomes (1)

• concentration of tramadol consumption

  all participants(400 patients) will receive tramadol 50 mg twice daily, titration will be done every 3days until 2 weeks,according to changes in visual analogue scale for pain maximum dose will be 400mg daily, one group of participants(200 patients) will receive duloxetine 30mg daily fixed dose in combination with tramadol,decrease in concentration of tramadol consumption means better results,the other group(200 patients) will receive placebo drug once daily in combination with tramadol.

  at one month

Secondary Outcomes (9)

• concentration of tramadol consumption

  at 2 month and 3 month

• - change in pain with visual analogue scale

  at 3,6,9 and 12 days , 2 weeks,1 month,2 month,3 month

• type of pain that relieved better

  at 1 month,2 month and 3 month

• Leeds Assessment of Neuropathic Symptoms and Signs Scale if neuropathic pain

  at 1 month,2 month and 3 month

• Scale Assessing Pain Intensity and Interference (Pain, Enjoyment, General Activity)

  at 1 month,2 month and 3 month

Study Arms (2)

•tramadol and duloxetine

EXPERIMENTAL

patients will receive tramadol 50 mg twice daily, titration will be done every 3days until 2 weeks, maximum dose will be 400mg daily and will receive duloxetine 30mg daily fixed dose in combination with tramadol. Investigators will follow up the patients for 3 months

Drug: Duloxetine 30 mg; Drug: Tramadol

tramadol and placebo

ACTIVE COMPARATOR

patients will receive tramadol 50 mg twice daily, titration will be done every 3days until 2 weeks, maximum dose will be 400mg daily and will receive placebo drug once daily in combination with tramadol. Investigators will follow up the patients for 3 months

Drug: Tramadol; Drug: Placebo

Interventions

Duloxetine 30 mg DRUG

tablet

Also known as: cymbatex 30 mg

•tramadol and duloxetine

Tramadol DRUG

tablet

Also known as: amadol

tramadol and placebo; •tramadol and duloxetine

Placebo DRUG

tablet

tramadol and placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cancer pain
• age from 20-70 years old.
• not receiving any type of analgesia before (opioid naïve, no adjuvants).

You may not qualify if:

• Difficult to be assessed for pain.
• Any contraindication for duloxetine or tramadol.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71111, Egypt

Location

Related Publications (30)

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MeSH Terms

Conditions

Cancer Pain

Interventions

Duloxetine Hydrochloride; Tramadol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• khaled M Fares, MD

  Assiut University

  STUDY DIRECTOR

• Ahmad M Abd EL Rahman, MD

  Assiut University

  STUDY DIRECTOR

• Diab F Hetta, MD

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 5, 2022
• Study Start: April 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)