Peripheral Neuropathy Due to ChemotherapyPhase 4NCT05875610
Preventive Approach Using Venlafaxine
A Phase 4 study testing Venlafaxine 75 MG and Gabapentin 400 mg in people with Peripheral Neuropathy Due to Chemotherapy, run by Mit Ghamr Oncology Center at 1 site in Egypt.
Trial summary
Peripheral and Motor neuropathy represent a main obstacle for a better quality of life for cancer patients, Venlafaxine is introduced in a new dosing regimen for treating of oxaliplatin and taxanes induced peripheral neuropathy in cancer patients. Read more about this study
- Who is it for?
- Ages 24 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Neuropathy Due to Chemotherapy
- What is being tested?
- Venlafaxine 75 MG and Gabapentin 400 mg
- 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
- 1 May 2023to 1 Dec 2023
- Phase
- Phase 4
- 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 24 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients >24 years of age, men or women to lower risk of suicidal tendency.
- Patients with histologically proven cancer
- Patients receiving oxaliplatin or taxanes-based regimen
- WHO performance status of 0-2
- serum AST or ALT no higher than two times the upper limit of normal
- serum creatinine level less than 2 mg/dL
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- platelet count of at least 100,000/mm3
- absolute neutrophil count of at least to 1.0 G/L
- Female patients, those with a negative urine pregnancy test.
Who cannot join
- Patients with brain or leptomeningeal metastasis.
- Patients with previous platinum-based chemotherapy
- Patients with history of alcoholic intoxication, diabetes, preexisting neuropathy or unstable psychological conditions.
- Patients with history of calcium/magnesium concomitant infusions, use of antiepileptics, antidepressants or lithium.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mit Ghamr Oncology Center
Al Mansurah, Dakahlia Governorate
Mahmoud A Mahrous, +201007778360, mahmodmahros71@gmail.com
About this study
Official title: Clinical Study on Chemotherapy Induced Peripheral Neuropathy: Preventive Approach Using Venlafaxine
Peripheral and Motor neuropathy represent a main obstacle for a better quality of life for cancer patients, Venlafaxine is introduced in a new dosing regimen for treating of oxaliplatin and taxanes induced peripheral neuropathy in cancer patients.
Read the detailed description
Neurologic complications of anticancer therapy may result from direct toxic effects on the nervous system or via indirectly induced metabolic derangements or cerebrovascular disorders. A wide range of neurologic complications can associate antineoplastic drug treatment. Among the widely used anticancer drugs are the platinum-based compounds cisplatin and oxaliplatin which are the most commonly associated with various forms of neurotoxicity. Moreover, taxanes (paclitaxel) are also associated with neurotoxicity. In a double-blind trial in which 48 patients who treated with oxaliplatin-induced acute neurotoxicity were randomly assigned to venlafaxine (37.5 mg extended release twice daily from day 2 to 11) or placebo, however the 2014 systematic review of neuroprotectants from ASCO concluded that the venlafaxine data were not strong enough to recommend its use in clinical practice, until additional supporting data become available. patients will be randomly assigned to treatment arms:
- Arm A: to receive venlafaxine hydrochloride 75 mg (Effexor X.R) 75mg once daily from day 1 to day 7 to avoid need of dose tapering .
- Arm B: to receive Gabapentin 100-400 mg once daily from day 1 to day 7.
- Being tested
- Venlafaxine 75 MG, Gabapentin 400 mg
- Keywords
- Peripheral neuropathy, Taxanes, oxaliplatin, Chemotherapy, Venlafaxine
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venlafaxine 75 MGDrug
Venlafaxine 75 mg extended release capsules for a 7-days duration
Gabapentin 400 mgDrug
Gabapentin 400 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| Venlafaxine Arm | Experimental | Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens. Receives: Drug: Venlafaxine 75 MG |
| Gabapentin Arm | Active comparator | Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens. Receives: Drug: Gabapentin 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade II or more peripheral neuropathy
Grading of chemotherapy induced peripheral neuropathy will be done using NCI-CTCAE version (5)
Measured: 4 months
Secondary outcomes (2)
The EORTC QLQ-CIPN20 subscales
Sensory subscale, motor, and autonomic subscales of CIPN20
Measured: 4 months
Pain Severity
The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 May 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathy Due to ChemotherapyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mit Ghamr Oncology Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Mahrous Ali, Mit Ghamr Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875610
- Sponsor's protocol ID
- 1
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Chemotherapy Induced Peripheral Neuropathy: Preventive Approach Using Venlafaxine
- ClinicalTrials.gov ID
- NCT05875610
- Acronym / sponsor ID
- 1
- Keywords
- Peripheral neuropathy, Taxanes, oxaliplatin, Chemotherapy, Venlafaxine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mit Ghamr Oncology CenterUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 25 May 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.
Peripheral and Motor neuropathy represent a main obstacle for a better quality of life for cancer patients, Venlafaxine is introduced in a new dosing regimen for treating of oxaliplatin and taxanes induced peripheral neuropathy in cancer patients.
Detailed description
Neurologic complications of anticancer therapy may result from direct toxic effects on the nervous system or via indirectly induced metabolic derangements or cerebrovascular disorders. A wide range of neurologic complications can associate antineoplastic drug treatment. Among the widely used anticancer drugs are the platinum-based compounds cisplatin and oxaliplatin which are the most commonly associated with various forms of neurotoxicity. Moreover, taxanes (paclitaxel) are also associated with neurotoxicity. In a double-blind trial in which 48 patients who treated with oxaliplatin-induced acute neurotoxicity were randomly assigned to venlafaxine (37.5 mg extended release twice daily from day 2 to 11) or placebo, however the 2014 systematic review of neuroprotectants from ASCO concluded that the venlafaxine data were not strong enough to recommend its use in clinical practice, until additional supporting data become available. patients will be randomly assigned to treatment arms:
- Arm A: to receive venlafaxine hydrochloride 75 mg (Effexor X.R) 75mg once daily from day 1 to day 7 to avoid need of dose tapering .
- Arm B: to receive Gabapentin 100-400 mg once daily from day 1 to day 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venlafaxine Arm | Experimental | Drug: Venlafaxine 75 MGPatients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens. |
| Gabapentin Arm | Active comparator | Drug: Gabapentin 400 mgPatients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens. |
Who may qualify
- Ages
- 24 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients >24 years of age, men or women to lower risk of suicidal tendency.
- Patients with histologically proven cancer
- Patients receiving oxaliplatin or taxanes-based regimen
- WHO performance status of 0-2
- serum AST or ALT no higher than two times the upper limit of normal
Key exclusion criteria (4 listed)
- Patients with brain or leptomeningeal metastasis.
- Patients with previous platinum-based chemotherapy
- Patients with history of alcoholic intoxication, diabetes, preexisting neuropathy or unstable psychological conditions.
- Patients with history of calcium/magnesium concomitant infusions, use of antiepileptics, antidepressants or lithium.
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 |
|---|---|---|
| Venlafaxine 75 MGVenlafaxine 75 mg extended release capsules for a 7-days duration | Drug | Venlafaxine Arm |
| Gabapentin 400 mgGabapentin 400 mg capsules | Drug | Gabapentin Arm |
Primary outcome
The incidence of grade II or more peripheral neuropathy
Time frame: 4 months
Grading of chemotherapy induced peripheral neuropathy will be done using NCI-CTCAE version (5)
2 secondary outcomes
The EORTC QLQ-CIPN20 subscales
Time frame: 4 months
Pain Severity
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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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 4 study testing Venlafaxine 75 MG and Gabapentin 400 mg in people with Peripheral Neuropathy Due to Chemotherapy, run by Mit Ghamr Oncology Center 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 9 inclusion and 4 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 25 May 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Mahmoud Mahrous (+201007778360, mahmodmahros71@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of grade II or more peripheral neuropathy (time frame: 4 months). 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 25 May 2023.