NCT05829967

Brief Summary

Neuropathies are a major cause of moderate to severe impairments in cancer patients. Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%.

Trial Health

35
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 P25-P50 for all trials

Timeline
Completed

Started Jun 2023

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

March 29, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

March 29, 2023

Last Update Submit

April 24, 2023

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

  • Number of patients with CIPN who receiving taxanes and platinum

    Number of patients with CIPN who receiving taxanes and platinum compounds in different chemotherapy regimens

    Baseline

  • Rae of recovery in patients with CIPN who receiving taxanes and platinum

    Possibility of recovery in patients with CIPN who receiving taxanes and platinum compounds in different chemotherapy regimens and assessment by nerve conduction test.

    Baseline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

60 cases aged 18 years to 75 years who receiving taxanes and platinum

You may qualify if:

  • Age ≥ 18 and \<75 .
  • Sex : Male or female
  • Adjuvant or metastatic
  • Receiving neurotoxic agents " platinum and taxanes "
  • No documentation of any other causes of neuropathy in their medical records as : congenital and DM

You may not qualify if:

  • Pt not receiving any neurotoxic CTH.
  • Detected other causes of neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Taha Zaki, Prof

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Mohamed Alaa El Deen, Assist prof

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Samar El Morshidy, Assist prof

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Walaa Khalifa

CONTACT

01091600834walaakhalifa64@gmail.com

Taha Zaki, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2023

First Posted

April 26, 2023

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

August 1, 2024

Last Updated

April 26, 2023

Record last verified: 2023-04