Breast CancerEarly Phase 1NCT06499090
Mirtazapine for Acute and Chronic Post Mastectomy Pain
A Early Phase 1 study testing Mirtazapine 30 MG in people with Breast Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
Our aim in this study will be to investigate the effect of mirtazapine on acute post-mastectomy pain manifested by total morphine consumption in first 24 hours and VAS score at rest and movement (primary outcomes). Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mirtazapine 30 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 20 Dec 2025
- Phase
- Early Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients aged 20-70 years scheduled for modified radical mastectomy with axillary dissection for breast carcinoma
Who cannot join
- known allergy to the study drugs significant organ dysfunction drug or alcohol abuse epilepsy patients with chronic pain or regularly receiving analgesics any psychiatric illness that would interfere with the perception and the assessment of pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Peri-operative Mirtazapine on Acute and Chronic Post Mastectomy Pain (Prospective Randomized Controlled Study)
Our aim in this study will be to investigate the effect of mirtazapine on acute post-mastectomy pain manifested by total morphine consumption in first 24 hours and VAS score at rest and movement (primary outcomes). chronic neuropathic pain using LANSS Pain Scale (Leeds Assessment of Neuropathic Signs and Symptoms) and to evaluate the quality of recovery using the quality of recovery-40scoring system(QoR-40) (secondary outcomes) following modified radical mastectomy for breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Mirtazapine 30 MG, Placebo
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirtazapine 30 MGDrug
patients will receive orally the night before surgery the study medication and daily up to two weeks after Mirtazapine 30 mg tablet
PlaceboDrug
patients will receive orally the night before surgery the study medication and daily up to two weeks after placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Mirtazapine group | Active comparator | patients will receive orally the night before surgery the study medication and daily up to two weeks after: Mirtazapine group: Mirtazapine 30 mg tablet Receives: Drug: Mirtazapine 30 MG |
| placebo group | Placebo comparator | patients will receive orally the night before surgery the study medication and daily up to two weeks after:
placebo tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative postoperative 24 h morphine consumption
Measured: 24 hours
Secondary outcomes (5)
The visual analogue score of pain intensity
VAS score of pain intensity at rest and arm movement (abduction of the arm of the operated side up to 90°) measured at (0, 2,4,8,12,16 and 24h) postoperatively.
Measured: 24 hours
The quality of recovery-40 questionnaire
1 means very poor recover and 40 very good recovery
Measured: 24 hours
Assessment of sedation level
Assessment of sedation level by the Modified Ramsay Sedation score
Measured: 24 hours
Assessment of chronic pain
Assessment of chronic pain will be done after the first, third and Sixth month post-operatively by LANSS to evaluate chronic pain in the Pain Clinic.
Measured: 6 months
Depression score
Depression score by the Patient Health Questionnaire(PHQ9)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Mar 2024
- Primary completion10 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Rabiee Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499090
- Sponsor's protocol ID
- mirtazapine for post mastectoy
- Status last verified
- Jan 2026
- First submitted
- 6 Jul 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peri-operative Mirtazapine on Acute and Chronic Post Mastectomy Pain (Prospective Randomized Controlled Study)
- ClinicalTrials.gov ID
- NCT06499090
- Acronym / sponsor ID
- mirtazapine for post mastectoy
- Conditions
- Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our aim in this study will be to investigate the effect of mirtazapine on acute post-mastectomy pain manifested by total morphine consumption in first 24 hours and VAS score at rest and movement (primary outcomes). chronic neuropathic pain using LANSS Pain Scale (Leeds Assessment of Neuropathic Signs and Symptoms) and to evaluate the quality of recovery using the quality of recovery-40scoring system(QoR-40) (secondary outcomes) following modified radical mastectomy for breast cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirtazapine group | Active comparator | Drug: Mirtazapine 30 MGpatients will receive orally the night before surgery the study medication and daily up to two weeks after: Mirtazapine group: Mirtazapine 30 mg tablet |
| placebo group | Placebo comparator | Drug: Placebopatients will receive orally the night before surgery the study medication and daily up to two weeks after: placebo tablet |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female patients aged 20-70 years scheduled for modified radical mastectomy with axillary dissection for breast carcinoma
Key exclusion criteria (1 listed)
- known allergy to the study drugs significant organ dysfunction drug or alcohol abuse epilepsy patients with chronic pain or regularly receiving analgesics any psychiatric illness that would interfere with the perception and the assessment of pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirtazapine 30 MGpatients will receive orally the night before surgery the study medication and daily up to two weeks after Mirtazapine 30 mg tablet | Drug | Mirtazapine group |
| Placebopatients will receive orally the night before surgery the study medication and daily up to two weeks after placebo tablet | Drug | placebo group |
Primary outcome
The cumulative postoperative 24 h morphine consumption
Time frame: 24 hours
5 secondary outcomes
The visual analogue score of pain intensity
Time frame: 24 hours
The quality of recovery-40 questionnaire
Time frame: 24 hours
Assessment of sedation level
Time frame: 24 hours
Assessment of chronic pain
Time frame: 6 months
Depression score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- combination of mirtazapine and milnacipran augments the extracellular levels of monoamines in the rat brain.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mirtazapine 30 MG in people with Breast Cancer, 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 1 inclusion and 1 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 22 Jan 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The cumulative postoperative 24 h morphine consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2026.