Chemotherapy-induced Peripheral NeuropathyNCT06352567
Symptoms Associated with Chemotherapy-Induced Peripheral Neuropathy
An observational study of Chemotherapy-induced Peripheral Neuropathy and Breast Cancer, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer remains the most frequent type of cancer globally. Nevertheless, the increased rate of disease-free survival of breast cancer brought the specific need of managing of short and long-term side effects of multimodal treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, Breast Cancer, Breast Cancer Female
- What is being tested?
- European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2024to 15 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were diagnosed with breast cancer and referred to the medical oncology unit for the purpose of systemic chemotherapy treatment were screened and invited to participate in this study.
Who may be able to join
- Being a volunteer to participate
- aged over 18 years old
- being female
- being a candidate for systemic chemotherapy
Who cannot join
- Having distant metastasis
- Having comorbidities that might contribute to or cause sensorial and motor deficits such as multiple sclerosis, diabetes, polyneuropathy, etc.,
- Prolonged surgical (if any) complications (i.e. pain, seroma, etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakircay University Çiğli State and Training Hospital, Department of Medical Oncology
Izmir, Çiğli, 35620
About this study
Official title: A View of Perceived Symptoms Associated with Chemotherapy-Induced Peripheral Neuropathy in Patients with Breast Cancer
Breast cancer remains the most frequent type of cancer globally. Nevertheless, the increased rate of disease-free survival of breast cancer brought the specific need of managing of short and long-term side effects of multimodal treatment. Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating conditions which is characterized by a wide variety of experienceable symptoms by patients that need to be addressed in detail. Therefore, in this cross-sectional study, it was aimed to assess the potential symptoms associated with CIPN of patients with breast cancer who underwent systemic chemotherapy. In addition, it was aimed to assess the potential associations between experienced symptoms of CIPN and sociodemographic (age, body mass index etc.) and clinical features (mean exposed dose, type of surgery (if any) etc.).
Read the detailed description
Patients with breast cancer who underwent systemic chemotherapy were assessed with the European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire within 1-2 months after completion of systemic chemotherapy. A simple data form was implemented in which patients' age, weight, height, marital status, smoking status, etc were investigated. In addition, the dose of the exposure of systemic chemotherapy was calculated according to the Body Surface Area (BSA) and DuBois formulation as follows: BSA [m2] = Weight [kg]0.425 × height (cm)0.725 × 0.007184]. The universal dose calculations were used to calculate the mean exposure according to the following doses for each patient-specific to their chemotherapy regimen: Four cycles of Anthracycline were applied 14 days apart 60 mg/m2 intravenous (IV), 12 cycles of Paclitaxel were applied seven days apart 80 mg/m2 IV, and four cycles of Docetaxel were applied 21 days apart 75 mg/m2 IV.
- Being tested
- European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire
- Keywords
- Breast Cancer, Neuropathy, Chemotherapeutic Toxicity, Chemotherapy-induced Peripheral Neuropathy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaireOther
It consists of a total of 20 items each is scored from "1: not at all" to "4: very much" in a 4-point Likert scale. Individuals are requested to fill out by considering their last week. Sensory, motor, and autonomic subscales are reported within its constructs. A total of 9, 8, and 3 items are referred to as sensory, motor, and autonomic disturbances, respectively
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer | Patients diagnosed with breast cancer who underwent systemic adjuvant or neoadjuvant chemotherapy will be assessed with the European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire within completion of the systemic chemotherapy in 1-2 months. Receives: Other: European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of perceived Chemotherapy Induced Peripheral Neuropathy symptoms
European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire was used to assess symtomps associated with CIPN. Higher scores indicate worse, or vice versa. Minimum and maximum score are 0 and 100, respectively. The questionnaire is calculated in three different sub-domains as follows: Autonomic, sensory and motor.
Measured: From completion of systemic chemotherapy up to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start18 Jan 2024
- Primary completion1 Jul 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Tuğral, Izmir Bakircay University
- Investigators
- Alper Tuğral, Ph.D., Principal investigator, Izmir Bakircay UniversityMurat Akyol, MD, Prof., Study director, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352567
- Sponsor's protocol ID
- BakircayU1394/1414
- Status last verified
- Feb 2025
- First submitted
- 29 Mar 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tugral A, Aribas Z, Akyol M, Bakar Y. Assessment of sensorimotor and strength related function of breast cancer patients during systemic drug therapy: a prospective observational study. BMC Cancer. 2023 Oct 14;23(1):981. doi: 10.1186/s12885-023-11494-x.
PubMed 37838686Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
PubMed 25261162Zhi WI, Chen P, Kwon A, Chen C, Harte SE, Piulson L, Li S, Patil S, Mao JJ, Bao T. Chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer survivors: a comparison of patient-reported outcomes and quantitative sensory testing. Breast Cancer Res Treat. 2019 Dec;178(3):587-595. doi: 10.1007/s10549-019-05416-4. Epub 2019 Aug 27.
PubMed 31456070Molinares D, Kurtevski S, Zhu Y. Chemotherapy-Induced Peripheral Neuropathy: Diagnosis, Agents, General Clinical Presentation, and Treatments. Curr Oncol Rep. 2023 Nov;25(11):1227-1235. doi: 10.1007/s11912-023-01449-7. Epub 2023 Sep 13.
PubMed 37702983Song SJ, Min J, Suh SY, Jung SH, Hahn HJ, Im SA, Lee JY. Incidence of taxane-induced peripheral neuropathy receiving treatment and prescription patterns in patients with breast cancer. Support Care Cancer. 2017 Jul;25(7):2241-2248. doi: 10.1007/s00520-017-3631-x. Epub 2017 Feb 16.
PubMed 28204996
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A View of Perceived Symptoms Associated with Chemotherapy-Induced Peripheral Neuropathy in Patients with Breast Cancer
- ClinicalTrials.gov ID
- NCT06352567
- Acronym / sponsor ID
- BakircayU1394/1414
- Keywords
- Breast Cancer, Neuropathy, Chemotherapeutic Toxicity, Chemotherapy-induced Peripheral Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 8 Apr 2024 (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.
Breast cancer remains the most frequent type of cancer globally. Nevertheless, the increased rate of disease-free survival of breast cancer brought the specific need of managing of short and long-term side effects of multimodal treatment. Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating conditions which is characterized by a wide variety of experienceable symptoms by patients that need to be addressed in detail. Therefore, in this cross-sectional study, it was aimed to assess the potential symptoms associated with CIPN of patients with breast cancer who underwent systemic chemotherapy. In addition, it was aimed to assess the potential associations between experienced symptoms of CIPN and sociodemographic (age, body mass index etc.) and clinical features (mean exposed dose, type of surgery (if any) etc.).
Detailed description
Patients with breast cancer who underwent systemic chemotherapy were assessed with the European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire within 1-2 months after completion of systemic chemotherapy. A simple data form was implemented in which patients' age, weight, height, marital status, smoking status, etc were investigated. In addition, the dose of the exposure of systemic chemotherapy was calculated according to the Body Surface Area (BSA) and DuBois formulation as follows: BSA [m2] = Weight [kg]0.425 × height (cm)0.725 × 0.007184]. The universal dose calculations were used to calculate the mean exposure according to the following doses for each patient-specific to their chemotherapy regimen: Four cycles of Anthracycline were applied 14 days apart 60 mg/m2 intravenous (IV), 12 cycles of Paclitaxel were applied seven days apart 80 mg/m2 IV, and four cycles of Docetaxel were applied 21 days apart 75 mg/m2 IV.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | – | Other: European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnairePatients diagnosed with breast cancer who underwent systemic adjuvant or neoadjuvant chemotherapy will be assessed with the European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire within completion of the systemic chemotherapy in 1-2 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed with breast cancer and referred to the medical oncology unit for the purpose of systemic chemotherapy treatment were screened and invited to participate in this study.
Key inclusion criteria (4 listed)
- Being a volunteer to participate
- aged over 18 years old
- being female
- being a candidate for systemic chemotherapy
Key exclusion criteria (3 listed)
- Having distant metastasis
- Having comorbidities that might contribute to or cause sensorial and motor deficits such as multiple sclerosis, diabetes, polyneuropathy, etc.,
- Prolonged surgical (if any) complications (i.e. pain, seroma, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaireIt consists of a total of 20 items each is scored from "1: not at all" to "4: very much" in a 4-point Likert scale. Individuals are requested to fill out by considering their last week. Sensory, motor, and autonomic subscales are reported within its constructs. A total of 9, 8, and 3 items are referred to as sensory, motor, and autonomic disturbances, respectively | Other | Breast Cancer |
Primary outcome
Assessment of perceived Chemotherapy Induced Peripheral Neuropathy symptoms
Time frame: From completion of systemic chemotherapy up to two months
European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire was used to assess symtomps associated with CIPN. Higher scores indicate worse, or vice versa. Minimum and maximum score are 0 and 100, respectively. The questionnaire is calculated in three different sub-domains as follows: Autonomic, sensory and motor.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Background: PubMed 37838686Tugral A, Aribas Z, Akyol M, Bakar Y. Assessment of sensorimotor and strength related function of breast cancer patients during systemic drug therapy: a prospective observational study. BMC Cancer. 2023 Oct 14;23(1):981. doi: 10.1186/s12885-023-11494-x.
- Background: PubMed 25261162Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
- Background: PubMed 31456070Zhi WI, Chen P, Kwon A, Chen C, Harte SE, Piulson L, Li S, Patil S, Mao JJ, Bao T. Chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer survivors: a comparison of patient-reported outcomes and quantitative sensory testing. Breast Cancer Res Treat. 2019 Dec;178(3):587-595. doi: 10.1007/s10549-019-05416-4. Epub 2019 Aug 27.
- Background: PubMed 37702983Molinares D, Kurtevski S, Zhu Y. Chemotherapy-Induced Peripheral Neuropathy: Diagnosis, Agents, General Clinical Presentation, and Treatments. Curr Oncol Rep. 2023 Nov;25(11):1227-1235. doi: 10.1007/s11912-023-01449-7. Epub 2023 Sep 13.
- Background: PubMed 28204996Song SJ, Min J, Suh SY, Jung SH, Hahn HJ, Im SA, Lee JY. Incidence of taxane-induced peripheral neuropathy receiving treatment and prescription patterns in patients with breast cancer. Support Care Cancer. 2017 Jul;25(7):2241-2248. doi: 10.1007/s00520-017-3631-x. Epub 2017 Feb 16.
- 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.
Alper Tuğral, Ph.D. principal investigator
Izmir Bakircay University
Murat Akyol, MD, Prof. study director
Izmir Bakircay University
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 Chemotherapy-induced Peripheral Neuropathy and Breast Cancer, run by Izmir Bakircay University 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 4 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: finished, as of the sponsor's last update on 19 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of perceived Chemotherapy Induced Peripheral Neuropathy symptoms (time frame: From completion of systemic chemotherapy up to two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06352567, which also lists 5 linked publications.
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 19 Feb 2025.