NCT07019324

Brief Summary

Cognitive impairment following chemotherapy is defined as chemotherapy-induced cognitive impairment (CCIID). CCIID, which significantly reduces the quality of life of cancer patients receiving chemotherapy, develops as a result of neurotoxicity. It is stated that 75% of patients receiving chemotherapy have cognitive changes. In addition, 35% of patients complain of various cognitive impairments (hearing, perception, decision-making, etc.) for a few months after chemotherapy ends. This situation makes life conditions very difficult for patients who are already experiencing a very difficult disease and treatment process. Brain-Derived Neurotrophic Factor (BDNF) is an extracellular signaling protein known for its dominant role in the development of the nervous system, such as neurogenesis, neuroprotection, neurodegeneration, synaptic plasticity, and resistance to neuronal stress. This protein has opposing effects with its mature form, pro-BDNF protein, and pro-BDNF/BDNF ratios affect neuronal health. Although a number of factors have been identified that are responsible for the deterioration of the cognitive levels of patients receiving chemotherapy, the role of BDNF and pro-BDNF levels in cognitive functions in cancer patients receiving chemotherapy is unknown. In light of this information, the aim of our study is to reveal the effects of chemotherapy-induced cognitive impairment (CIID) on pro-BDNF/BDNF levels and to evaluate the cognitive effects. In line with this aim, patients who apply to Çanakkale Onsekiz Mart University, Faculty of Medicine, Department of Oncology, Polyclinic and Chemotherapy Unit and who have not yet received their first chemotherapy will be included in the study. Before the first chemotherapy, during routine follow-ups in the 3rd month of chemotherapy and in the 6th month in Aydın, 1 extra tube of blood will be taken and BDNF levels will be examined. At the same time, the Montreal Cognitive Assessment (MoCA) test will be applied to the patients to evaluate their cognitive functions. Thus, serum BNDF, proBDNF levels will be determined and the BDNF/proBDNF ratio will be revealed.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress94%
Mar 2025Jun 2026

Study Start

First participant enrolled

March 17, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2026

Last Updated

June 13, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

June 5, 2025

Last Update Submit

June 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • BDNF level

    BDNF level from every 3 months

    Until 9 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Applying Çanakkale Onsekiz Mart University Oncology Department

You may qualify if:

  • Cancer definations and decided the chemotherapy treatment

You may not qualify if:

  • Having other disease whixh effected cognitive function
  • Brain cancers
  • Brain metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çanakkale Onsekiz Mart University

Çanakkale, Merkez, 17020, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Çanakkale Onsekiz Mart University

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 13, 2025

Study Start

March 17, 2025

Primary Completion (Estimated)

June 4, 2026

Study Completion (Estimated)

June 4, 2026

Last Updated

June 13, 2025

Record last verified: 2025-01

Locations