Symptoms Associated with Chemotherapy-Induced Peripheral Neuropathy

NCT06352567 | Completed

• 1 other identifier: BakircayU1394/1414
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.).

Conditions

Chemotherapy-induced Peripheral Neuropathy; Breast Cancer; Breast Cancer Female

Keywords

Breast Cancer; Neuropathy; Chemotherapeutic Toxicity; Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  From completion of systemic chemotherapy up to two months

Study Arms (1)

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.

Other: European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire

Interventions

European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire OTHER

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

Breast Cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Being female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Bakircay University Çiğli State and Training Hospital, Department of Medical Oncology

Izmir, Çiğli, 35620, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 37838686 BACKGROUND

• 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.

  PMID: 25261162 BACKGROUND

• 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.

  PMID: 31456070 BACKGROUND

• 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.

  PMID: 37702983 BACKGROUND

• 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.

  PMID: 28204996 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alper Tuğral, Ph.D.

  Izmir Bakircay University

  PRINCIPAL INVESTIGATOR

• Murat Akyol, MD, Prof.

  Izmir Bakircay University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 8, 2024
• Study Start: January 18, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 15, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

TU (1)