Neuropathy in Cacer PatienPhase 2NCT06091553
Comparison of the Efficacy and Safety of Duloxetine Augmented With Gabapentin and Duloxetine Augmented With Amitriptyline vs Duloxetine Alone in Chemotherapy -Induced Neuropathy
A Phase 2 study testing Duloxetine alone, Duloxetine augmented with gabapentin and Duloxetine augmented with amitriptyline (as combined therapy) in people with Neuropathy in Cacer Patien, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This study aimed to elucidate the relationship between the Efficacy and Safety of Comparison of the Efficacy and Safety Duloxetine augmented with gabapentin and amitriptyline augmented with Duloxetine vs duloxetine alone in chemotherapy -Induced Neuropathy in cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuropathy in Cacer Patien
- What is being tested?
- Duloxetine alone, Duloxetine augmented with gabapentin and Duloxetine augmented with amitriptyline (as combined therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2023to 31 Dec 2024
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients of any age must have histologically or cytologically confirmed cancer by the Laboratory of Pathology.
- Patients must sign an informed consent form (ICF) voluntarily and be able to understand and comply with the requirements of the study;
- Patients must be 18 to 75 years of age (including cut-offs) on the date of signing the informed consent form, regardless of gender;
- Patients must received treatment with a chemotherapy regimen .
- Patients must have ≥ grade 1 sensory chemotherapy-induced peripheral neuropathy (CIPN) with NRS ≥ 4/10 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0 grading scale
- Eastern Cooperative Oncology Group performance status (ECOG PS): 0-2;
- Expected survival of ≥ 3 months
- There is no maximum number of prior medical therapies.
Who cannot join
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to duloxetine, amitriptyline and gabapentin
- Pregnant women are excluded from this study.
- Life expectancy less than 6 months
- Inability or unwillingness to comply with research protocols.
- Patients with the presence of active brain or meningeal metastases.
- Patients with the presence of uncontrolled closed-angle glaucoma.
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- Patients with the presence of neuropathy caused by any type of nerve compression as diabetes.
- The presence of mental illness, epilepsy, mania, suicidal depression, dementia or alcohol or drug abuse that may have an impact on compliance with trial requirements.
- The presence of comorbid cardiovascular disease, including but not limited to: (1) New York Heart Association (NYHA) criteria ≥ grade 2 heart failure; (2) severe/unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months prior to first dose; (4) atrial fibrillation and supraventricular or ventricular arrhythmias requiring treatment; (5) pre-existing symptomatic superior vena cava syndrome; (6) corrected QT interval (QTc) > 450 ms (men); QTc > 470 ms (women); (7) hypertensive disease not controlled by antihypertensive medication: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
- Patients with other medical history or evidence of disease that has the potential to confound trial results are excluded from the study,
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Seuf University Hospital
Banī Suwayf
ahmed H shaaban, MD, 0201061246789, ahmedhasan_dr@yahoo.com
About this study
Official title: Comparison of the Efficacy and Safety of Duloxetine Augmented With Gabapentin and Duloxetine Augmented With Amitriptyline vs Duloxetine Alone in Chemotherapy -Induced Neuropathy: A Randomized Controlled Trial
This study aimed to elucidate the relationship between the Efficacy and Safety of Comparison of the Efficacy and Safety Duloxetine augmented with gabapentin and amitriptyline augmented with Duloxetine vs duloxetine alone in chemotherapy -Induced Neuropathy in cancer patients.
- Conditions
- Neuropathy in Cacer Patien
- Being tested
- Duloxetine alone, Duloxetine augmented with gabapentin, Duloxetine augmented with amitriptyline (as combined therapy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine aloneDrug
30 mg once daily for 1 week, then 60 mg once daily
Duloxetine augmented with gabapentinDrug
30 mg once daily for 1 week, then 60 mg once daily 300 mg at bedtime
Duloxetine augmented with amitriptyline (as combined therapy)Drug
10 to 25 mg once daily at bedtime 30 mg once daily for 1 week, then 60 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine alone (as monotherapy) | Active comparator | Duloxetine alone (as monotherapy) Receives: Drug: Duloxetine alone |
| Duloxetine augmented with gabapentin (as combined therapy) | Active comparator | Duloxetine augmented with gabapentin (as combined therapy) Receives: Drug: Duloxetine augmented with gabapentin |
| Duloxetine augmented with amitriptyline (as combined therapy) | Active comparator | Duloxetine augmented with amitriptyline (as combined therapy) Receives: Drug: Duloxetine augmented with amitriptyline (as combined therapy) |
| control | No intervention | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in numerical rating scale (NRS) daily pain measured during the final follow-up week (week 8) between the treatments.
Measured: 8 week
Secondary outcomes (2)
Quality of Life Score
Measured: 8 week
Anxiety and depression Score
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start10 Oct 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathy in Cacer PatienStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager salah el din, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091553
- Sponsor's protocol ID
- IORG0006240
- Status last verified
- Apr 2024
- First submitted
- 14 Oct 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Duloxetine Augmented With Gabapentin and Duloxetine Augmented With Amitriptyline vs Duloxetine Alone in Chemotherapy -Induced Neuropathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06091553
- Acronym / sponsor ID
- IORG0006240
- Conditions
- Neuropathy in Cacer Patien
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Oct 2023 (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.
This study aimed to elucidate the relationship between the Efficacy and Safety of Comparison of the Efficacy and Safety Duloxetine augmented with gabapentin and amitriptyline augmented with Duloxetine vs duloxetine alone in chemotherapy -Induced Neuropathy in cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Duloxetine alone (as monotherapy) | Active comparator | Drug: Duloxetine aloneDuloxetine alone (as monotherapy) |
| Duloxetine augmented with gabapentin (as combined therapy) | Active comparator | Drug: Duloxetine augmented with gabapentinDuloxetine augmented with gabapentin (as combined therapy) |
| Duloxetine augmented with amitriptyline (as combined therapy) | Active comparator | Drug: Duloxetine augmented with amitriptyline (as combined therapy)Duloxetine augmented with amitriptyline (as combined therapy) |
| control | No intervention | –control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -Patients of any age must have histologically or cytologically confirmed cancer by the Laboratory of Pathology.
- Patients must sign an informed consent form (ICF) voluntarily and be able to understand and comply with the requirements of the study;
- Patients must be 18 to 75 years of age (including cut-offs) on the date of signing the informed consent form, regardless of gender;
- Patients must received treatment with a chemotherapy regimen .
- Patients must have ≥ grade 1 sensory chemotherapy-induced peripheral neuropathy (CIPN) with NRS ≥ 4/10 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0 grading scale
Key exclusion criteria (10 listed)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to duloxetine, amitriptyline and gabapentin
- Pregnant women are excluded from this study.
- Life expectancy less than 6 months
- Inability or unwillingness to comply with research protocols.
- Patients with the presence of active brain or meningeal metastases.
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 |
|---|---|---|
| Duloxetine alone30 mg once daily for 1 week, then 60 mg once daily | Drug | Duloxetine alone (as monotherapy) |
| Duloxetine augmented with gabapentin30 mg once daily for 1 week, then 60 mg once daily 300 mg at bedtime | Drug | Duloxetine augmented with gabapentin (as combined therapy) |
| Duloxetine augmented with amitriptyline (as combined therapy)10 to 25 mg once daily at bedtime 30 mg once daily for 1 week, then 60 mg once daily | Drug | Duloxetine augmented with amitriptyline (as combined therapy) |
Primary outcome
The difference in numerical rating scale (NRS) daily pain measured during the final follow-up week (week 8) between the treatments.
Time frame: 8 week
2 secondary outcomes
Quality of Life Score
Time frame: 8 week
Anxiety and depression Score
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duloxetine alone, Duloxetine augmented with gabapentin and Duloxetine augmented with amitriptyline (as combined therapy) in people with Neuropathy in Cacer Patien, run by Beni-Suef 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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hager salah (0097336679556, hager.salah@rocketmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in numerical rating scale (NRS) daily pain measured during the final follow-up week (week 8) between the treatments. (time frame: 8 week). 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 16 Apr 2024.