NCT04737967

Brief 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. 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 4, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

January 30, 2021

Last Update Submit

January 30, 2021

Conditions

Oncology PainChemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

  • 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).

    6 weeks

  • Electrophysiological studies

    nerve conduction velocity at the end of the study

    6 weeks

Study Arms (2)

Venlafaxine Treated Arm

EXPERIMENTAL
Drug: Venlafaxine

Memantine Treated Arm

EXPERIMENTAL
Drug: Memantine

Interventions

VenlafaxineDRUG

Patients will receive will receive Venlafaxine extended release (37.5 mg) tablets once daily(Zimmerman et al., 2016)

Venlafaxine Treated Arm
MemantineDRUG

Patients will receive memantine (10 mg) once daily (Morel et al., 2016)

Memantine Treated Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Cairo University - Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Interventions

Venlafaxine HydrochlorideMemantine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipidsAmantadineAdamantaneBridged-Ring Compounds

Central Study Contacts

Gehad Sayed Ahmed, MD

CONTACT

+201222352664Gehad.S.Fadl@kasralainy.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 30, 2021

First Posted

February 4, 2021

Study Start

February 15, 2021

Primary Completion

August 15, 2021

Study Completion

October 1, 2021

Last Updated

February 4, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)