Clinical trial NCT06352567: Symptoms Associated with Chemotherapy-Induced Peripheral Neuropathy
Official title: A View of Perceived Symptoms Associated with Chemotherapy-Induced Peripheral Neuropathy in Patients with Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-induced Peripheral Neuropathy
Breast Cancer
Breast Cancer Female
Keywords: Breast Cancer
Neuropathy
Chemotherapeutic Toxicity
Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Being a volunteer to participate
* aged over 18 years old
* being female
* being a candidate for systemic chemotherapy

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: Assessment of perceived Chemotherapy Induced Peripheral Neuropathy symptoms
timeFrame: From completion of systemic chemotherapy up to two months
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Bakircay University Çiğli State and Training Hospital, Department of Medical Oncology
state: Çiğli
Study officials:
affiliation: Izmir Bakircay University
name: Alper Tuğral, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir Bakircay University
name: Murat Akyol, MD, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Seretny 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.
citation: Zhi 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.
citation: Molinares 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.
citation: Song 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.