Preventive Approach Using Venlafaxine | NCT05875610

Studies
Preventive Approach Using Venlafaxine

NCT05875610

Sponsor

Mit Ghamr Oncology Center

Status

Unknown status

Last Update Posted

May 25, 2023Actual

Enrollment

60Estimated

Phase

Phase 4

Conditions

Peripheral Neuropathy Due to Chemotherapy

Interventions

Venlafaxine 75 MG
Gabapentin 400 mg

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Actual

Primary Completion Date

Oct 1, 2023Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

May 16, 2023

First Submission Date that Met QC Criteria

May 16, 2023

First Posted Date

May 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2023

Last Update Posted Date

May 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Ahmed Mahrous Ali, Head of clinical pharmacy department, Mit Ghamr Oncology CenterPrincipal Investigator

Lead Sponsor

Mit Ghamr Oncology CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Venlafaxine Arm	Experimental	Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.	Drug: Venlafaxine 75 MG
Gabapentin Arm	Active Comparator	Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.	Drug: Gabapentin 400 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Venlafaxine 75 MG	Drug	Venlafaxine 75 mg extended release capsules for a 7-days duration	Venlafaxine Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of grade II or more peripheral neuropathy	Grading of chemotherapy induced peripheral neuropathy will be done using NCI-CTCAE version (5)	4 months

Secondary Outcomes

Measure	Description	Time Frame
The EORTC QLQ-CIPN20 subscales	Sensory subscale, motor, and autonomic subscales of CIPN20	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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Mahrous	Contact	+201007778360		mahmodmahros71@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mit Ghamr Oncology Center	Recruiting	Al Mansurah	Dakahlia Governorate		Egypt

Condition Browse Module

MeSH Terms

ID	Term
D010523	Peripheral Nervous System Diseases

Ancestor Terms

ID	Term
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069470	Venlafaxine Hydrochloride
D000077206	Gabapentin

Ancestor Terms

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930

Browse Leaves

Not provided

Browse Branches

Not provided