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AzTrials

Cancer PainNCT05311774

Efficacy of Duloxetine in Conjunction With Tramadol for Chronic Cancer Pain

A study testing Duloxetine 30 mg and Tramadol in people with Cancer Pain, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Cancer Pain
What is being tested?
Duloxetine 30 mg and Tramadol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
1 siteEgypt
Study dates
1 Apr 2022to 1 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut University

    Asyut, 71111

Other trials in Egypt

About this study

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.

Read more

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 .

Read the detailed description

Cancer pain is one of the most common and problematic symptoms.uncontrolled pain affect quality of life and daily activities .Cancer pain has two main categories nociceptive and neuropathic pain,Cancer pain is often a combination of nociceptive and neuropathic pain.

A framework for managing pain often starts with the World Health Organization (WHO) Analgesic Ladder, step 1 use non opioid analgesics, step 2 weak opioids, step 3 strong opioids, step 4 interventions non pharmacological, adjuvants can be added to any step .

Opioids are typically the most common drugs used in the treatment of cancer pain. They work by binding to μ-opioid receptors within the central nervous system, which are responsible for opioid mediated analgesia, respiratory depression, sedation, physiological dependence, and tolerance, they are limited due to their side effects as nausea, constipation, sedation, and confusion, prolonged use of opioids may lead to development of tolerance, abnormal hypersensitivity to pain.

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. It has been also shown to inhibit reuptake of serotonin and norepinephrine, which synergistically enhances its weak opioid mechanism of action.

This may explain the reduced incidences of abuse, respiratory depression and other adverse effects of traditional opioids in patients on long-term tramadol therapy.it is a useful drug in patients with cancer pain both with nociceptive and neuropathic 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.

Adjuvant analgesics are drugs primarily marketed for other indications, such as depression, but also have an important role in cancer pain management. Antidepressants, such as serotonin- norepinephrine reuptake inhibitors (duloxetine, venlafaxine) or tricyclics ( nortriptyline, amitriptyline) and anticonvulsants (pregabalin, gabapentin, carbamazepine) have efficacy in the treatment of pain, particularly neuropathic pain .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 , it enhances the effect of serotonin and norepinephrine on descending inhibitory pain pathways in the brain and spinal cord and activation of some cerebral prefrontal areas . Besides, it has been claimed that Duloxetine has an anti-nociceptive effect through Na + channel block , therefore it suppresses the neuronal cell firing resulting from peripheral injury . The most common adverse effects of duloxetine, which may lead to discontinuation of the drug, are nausea, dizziness, and somnolence .There is a possibility that duloxetine was effective in both activation of the descending pain modulatory system and the improvement of depressive mood, the effect may have partly taken place due to elevation of the pain threshold through the antidepressant effect of duloxetine . Recently, the efficacy of duloxetine has been reported in patients with chemotherapy-induced peripheral neuropathy (CIPN) and in non-cancer neuropathic pain. .

Conditions
Cancer Pain
Being tested
Duloxetine 30 mg, Tramadol, Placebo
Keywords
duloxetine, tramadol, cancer pain
Medical subject headings
Cancer Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Duloxetine 30 mgDrug

    Also called cymbatex 30 mg

    tablet

  • TramadolDrug

    Also called amadol

    tablet

  • PlaceboDrug

    tablet

Study groups in NCT05311774
Study groupRoleWhat they receive
•tramadol and duloxetineExperimentalpatients 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
Receives: Drug: Duloxetine 30 mg; Drug: Tramadol
tramadol and placeboActive comparatorpatients 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
Receives: Drug: Tramadol; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at one month

Secondary outcomes (9)

  1. concentration of tramadol consumption

    all participants(400 patients) will receive tramadol 50 mg twice daily, titration will be done 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.

    Measured: at 2 month and 3 month

  2. - change in pain with visual analogue scale

    subjective scale by the participants for pain intensity from 0 to 10, minimum value is zero that means no pain, maximum value is 10 that means unbearable pain, higher scores mean worse outcome

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

  3. type of pain that relieved better

    type of pain that responds better to duloxetine and tramadol (neuropathic or nociceptive), using visual analogue scale for pain intensity (subjective scale by the participants for pain intensity from 0 to 10, minimum value is zero that means no pain, maximum value is 10 that means unbearable pain, higher scores mean worse outcome)

    Measured: at 1 month,2 month and 3 month

  4. Leeds Assessment of Neuropathic Symptoms and Signs Scale if neuropathic pain

    used for neuropathic pain consists of seven questions minimum value 0 ,maximum value 24,scoring a score of 12 or more suggests pain of predominantly neuropathic origin

    Measured: at 1 month,2 month and 3 month

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

    consisting of three questions for the participant,responses from 0 to 10 ,responses to three questions added then divided by three to get a mean score out of ten

    Measured: at 1 month,2 month and 3 month

  6. Depression scores by the Patient Health Questionnaire

    consists of 9 questions for the participant ,This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, total score for the nine items ranges from 0 to 27,higher scores means worse outcome

    Measured: at 1 month,2 month and 3 month

  7. Anxiety scores by the Patient Health Questionnaire

    consists of 7 questions for the participant ,This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, total score for the seven items ranges from 0 to 21,higher scores means worse outcome

    Measured: at 1 month,2 month and 3 month

  8. Flanagan Quality of Life Scale

    consists of 16 items ,seven responses are delighted(7),pleased(6),mostly satisfied(5),mixed(4),mostly dissatisfied (3),unhappy(2),terrible(1),ranging from 16 to 112,average for healthy 90

    Measured: at 1 month,2 month and 3 month

  9. Side effects as nausea, vomiting, constipation, sedation, arrhythmia and hypertension

    participants will be asked about side effects from duloxetine as nausea,vomiting, constipation, sedation, (onset,duration,offset, bearable or not ,affecting quality of life), arrhythmia (type of arrhythmia from electrocardiogram ,onset,duration,offset),hypertension (by measuring blood pressure ,onset ,duration ,offset)

    Measured: up to 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start1 Apr 2022
  3. Primary completion1 Oct 2025
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05311774
Sponsor's protocol ID
Duloxetine in cancer pain
Status last verified
Dec 2025
First submitted
15 Mar 2022
Last updated
3 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • van den Beuken-van Everdingen MH, Hochstenbach LM, Joosten EA, Tjan-Heijnen VC, Janssen DJ. Update on Prevalence of Pain in Patients With Cancer: Systematic Review and Meta-Analysis. J Pain Symptom Manage. 2016 Jun;51(6):1070-1090.e9. doi: 10.1016/j.jpainsymman.2015.12.340. Epub 2016 Apr 23.

    PubMed 27112310

  • Greco MT, Roberto A, Corli O, Deandrea S, Bandieri E, Cavuto S, Apolone G. Quality of cancer pain management: an update of a systematic review of undertreatment of patients with cancer. J Clin Oncol. 2014 Dec 20;32(36):4149-54. doi: 10.1200/JCO.2014.56.0383. Epub 2014 Nov 17.

    PubMed 25403222

  • Ashby MA, Fleming BG, Brooksbank M, Rounsefell B, Runciman WB, Jackson K, Muirden N, Smith M. Description of a mechanistic approach to pain management in advanced cancer. Preliminary report. Pain. 1992 Nov;51(2):153-161. doi: 10.1016/0304-3959(92)90256-B.

    PubMed 1283009

  • Knudsen AK, Aass N, Fainsinger R, Caraceni A, Klepstad P, Jordhoy M, Hjermstad MJ, Kaasa S. Classification of pain in cancer patients--a systematic literature review. Palliat Med. 2009 Jun;23(4):295-308. doi: 10.1177/0269216309103125. Epub 2009 Mar 13.

    PubMed 19286741

  • . World Health Organization. Cancer Pain Relief. 2. Geneva: WHO; 1996. 7.

  • Gutstein HB, Akil H. Opioid analgesics. In: Hardman JG, Limbrid E, editors. Goodman and Gilman's the Pharmacological Basis of Therapeutics. 10. New York: McGraw-Hill Professional; 2001. pp. 569-619.

  • Alvarez V, Arttamangkul S, Williams JT. A RAVE about opioid withdrawal. Neuron. 2001 Dec 6;32(5):761-3. doi: 10.1016/s0896-6273(01)00530-x.

    PubMed 11738021

  • Raffa RB, Friderichs E, Reimann W, Shank RP, Codd EE, Vaught JL. Opioid and nonopioid components independently contribute to the mechanism of action of tramadol, an 'atypical' opioid analgesic. J Pharmacol Exp Ther. 1992 Jan;260(1):275-85.

    PubMed 1309873

  • Desmeules JA, Piguet V, Collart L, Dayer P. Contribution of monoaminergic modulation to the analgesic effect of tramadol. Br J Clin Pharmacol. 1996 Jan;41(1):7-12. doi: 10.1111/j.1365-2125.1996.tb00152.x.

    PubMed 8824687

  • Raffa RB. Pharmacology of oral combination analgesics: rational therapy for pain. J Clin Pharm Ther. 2001 Aug;26(4):257-64. doi: 10.1046/j.1365-2710.2001.00355.x.

    PubMed 11493367

  • Russell IJ, Kamin M, Bennett RM, Schnitzer TJ, Green JA, Katz WA. Efficacy of tramadol in treatment of pain in fibromyalgia. J Clin Rheumatol. 2000 Oct;6(5):250-7. doi: 10.1097/00124743-200010000-00004.

    PubMed 19078481

  • Arbaiza D, Vidal O. Tramadol in the treatment of neuropathic cancer pain: a double-blind, placebo-controlled study. Clin Drug Investig. 2007;27(1):75-83. doi: 10.2165/00044011-200727010-00007.

    PubMed 17177582

  • Duhmke RM, Cornblath DD, Hollingshead JR. Tramadol for neuropathic pain. Cochrane Database Syst Rev. 2004;(2):CD003726. doi: 10.1002/14651858.CD003726.pub2.

    PubMed 15106216

  • Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7.

    PubMed 25575710

  • Collins SL, Moore RA, McQuayHJ, Wiffen P. Antidepressants and anticonvulsants for diabetic neuropathy and postherpetic neuralgia: a quantitative systematic review. J Pain Symptom Manage. 2000 Dec;20(6):449-58. doi: 10.1016/s0885-3924(00)00218-9.

    PubMed 11131263

Questions about this trial

What is this clinical trial studying?

A study testing Duloxetine 30 mg and Tramadol in people with Cancer Pain, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

concentration of tramadol consumption (time frame: at one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05311774, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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