Oncology PainPhase 2/3NCT04737967
The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy
A Phase 2/3 study testing Venlafaxine and Memantine in people with Oncology Pain and Chemotherapy-induced Peripheral Neuropathy, run by Mendel AI at 1 site in Egypt.
Trial summary
This is a double blinded two-arm randomized case-only interventional trial. A total of 60 patients who are to receive Paclitaxel to be included and allocated in two groups. The protocol is to be reviewed by the Research Ethics Committee of Faculty of Medicine Cairo University. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Oncology Pain, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Venlafaxine and Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2021to 1 Oct 2021
- Phase
- Phase 2/3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients, 18 years of age or older, with a cancer treated with Paclitaxel
- Patients must have a life expectancy of at least 24 weeks.
- Patients must sign an informed consent.
- Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry.
- Patient matching high risk on the CIPN risk stratification scoring system
Who cannot join
- Patients with symptomatic brain metastases.
- Pregnant women or nursing mothers. Patients of child bearing potential must use adequate contraception.
- Patients may receive no other concurrent complementary medicines during this study.
- Patients with neuropathy induced diabetes.
- Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Cairo University - Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine
Cairo, 11562
Gehad Sayed Ahmed, MD, +201222352664, Gehad.S.Fadl@kasralainy.edu.eg
About this study
This is a double blinded two-arm randomized case-only interventional trial. A total of 60 patients who are to receive Paclitaxel to be included and allocated in two groups. The protocol is to be reviewed by the Research Ethics Committee of Faculty of Medicine Cairo University.
All procedure will be done in Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine.
The first arm (Venlafaxine group) will receive Venlafaxine extended release (37.5 mg) tablets (Zimmerman et al., 2016).
The second arm (Memantine group) will receive memantine 10 mg once daily (Morel et al., 2016)
- Being tested
- Venlafaxine, Memantine
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenlafaxineDrug
Patients will receive will receive Venlafaxine extended release (37.5 mg) tablets once daily(Zimmerman et al., 2016)
MemantineDrug
Patients will receive memantine (10 mg) once daily (Morel et al., 2016)
| Study group | Role | What they receive |
|---|---|---|
| Venlafaxine Treated Arm | Experimental | Not described Receives: Drug: Venlafaxine |
| Memantine Treated Arm | Experimental | Not described Receives: Drug: Memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average daily pain intensity
Change in average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF). Absolute change in the average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF) from baseline to the end of 6 weeks measured by item # 5 of Brief Pain Inventory Score (BPI-SF). The BPI assesses pain at its "worst," "least," "average," and "now" (current pain).
Measured: 6 weeks
Electrophysiological studies
nerve conduction velocity at the end of the study
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start15 Feb 2021 (estimated)
- Primary completion15 Aug 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncology PainStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mendel AI
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, G Fadl, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737967
- Sponsor's protocol ID
- CIPN101
- Status last verified
- Jan 2021
- First submitted
- 30 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT04737967
- Acronym / sponsor ID
- CIPN101
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mendel AIIndustry (pharma, biotech, devices)
- Collaborators
- Cairo University
- Study start
- 15 Feb 2021 (estimated)
- Primary completion
- 15 Aug 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 4 Feb 2021 (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 is a double blinded two-arm randomized case-only interventional trial. A total of 60 patients who are to receive Paclitaxel to be included and allocated in two groups. The protocol is to be reviewed by the Research Ethics Committee of Faculty of Medicine Cairo University.
All procedure will be done in Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine.
The first arm (Venlafaxine group) will receive Venlafaxine extended release (37.5 mg) tablets (Zimmerman et al., 2016).
The second arm (Memantine group) will receive memantine 10 mg once daily (Morel et al., 2016)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venlafaxine Treated Arm | Experimental | Drug: Venlafaxine |
| Memantine Treated Arm | Experimental | Drug: Memantine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients, 18 years of age or older, with a cancer treated with Paclitaxel
- Patients must have a life expectancy of at least 24 weeks.
- Patients must sign an informed consent.
- Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry.
- Patient matching high risk on the CIPN risk stratification scoring system
Key exclusion criteria (5 listed)
- Patients with symptomatic brain metastases.
- Pregnant women or nursing mothers. Patients of child bearing potential must use adequate contraception.
- Patients may receive no other concurrent complementary medicines during this study.
- Patients with neuropathy induced diabetes.
- Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections.
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 |
|---|---|---|
| VenlafaxinePatients will receive will receive Venlafaxine extended release (37.5 mg) tablets once daily(Zimmerman et al., 2016) | Drug | Venlafaxine Treated Arm |
| MemantinePatients will receive memantine (10 mg) once daily (Morel et al., 2016) | Drug | Memantine Treated Arm |
Primary outcome
Change in average daily pain intensity
Time frame: 6 weeks
Change in average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF). Absolute change in the average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF) from baseline to the end of 6 weeks measured by item # 5 of Brief Pain Inventory Score (BPI-SF). The BPI assesses pain at its "worst," "least," "average," and "now" (current pain).
Electrophysiological studies
Time frame: 6 weeks
nerve conduction velocity at the end of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Venlafaxine and Memantine in people with Oncology Pain and Chemotherapy-induced Peripheral Neuropathy, run by Mendel AI 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 5 inclusion and 5 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 4 Feb 2021. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Gehad Sayed Ahmed, MD (+201222352664, Gehad.S.Fadl@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average daily pain intensity (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 4 Feb 2021.