BDNFCARENCT07019324
BDNF Levels in Cancer Patients Receiving Chemotherapy
An observational study of BDNF and Cognitive Functions, run by Cemre Aydeğer at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BDNF, Cognitive Functions, Chemotherapy
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Mar 2025to 4 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Applying Çanakkale Onsekiz Mart University Oncology Department
Who may be able to join
- Cancer definations and decided the chemotherapy treatment
Who cannot join
- Having other disease whixh effected cognitive function
- Brain cancers
- Brain metastasis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çanakkale Onsekiz Mart University
Çanakkale, Merkez, 17020
About this study
Official title: Evaluation of Cognitive Disorders and Serum BDNF/ProBDNF Levels in Cancer Patients Receiving Chemotherapy
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.
Read the detailed description
Detection of chemotherapy-induced cognitive impairment
- Conditions
- BDNF, Cognitive Functions, Chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
BDNF level
BDNF level from every 3 months
Measured: Until 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start17 Mar 2025
- Primary completion4 Jun 2026 (estimated)
- Study completion4 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BDNFStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cemre Aydeğer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cemre Aydeğer, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019324
- Sponsor's protocol ID
- TKB-2025-5052
- Other IDs
- TKB-2025-5052
- Acronym
- CARE
- Status last verified
- Jan 2025
- First submitted
- 5 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cognitive Disorders and Serum BDNF/ProBDNF Levels in Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT07019324
- Acronym / sponsor ID
- CARE / TKB-2025-5052
- Conditions
- BDNF, Cognitive Functions, Chemotherapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cemre AydeğerUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 4 Jun 2026 (estimated)
- Study completion
- 4 Jun 2026 (estimated)
- First posted
- 13 Jun 2025 (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.
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.
Detailed description
Detection of chemotherapy-induced cognitive impairment
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Applying Çanakkale Onsekiz Mart University Oncology Department
Key inclusion criteria (1 listed)
- Cancer definations and decided the chemotherapy treatment
Key exclusion criteria (3 listed)
- Having other disease whixh effected cognitive function
- Brain cancers
- Brain metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BDNF level
Time frame: Until 9 month
BDNF level from every 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BDNF and Cognitive Functions, run by Cemre Aydeğer at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 13 Jun 2025. 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 Turkey (Türkiye). 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDNF level (time frame: Until 9 month). 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 13 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.