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NCT Number: NCT06352567

Symptoms Associated with Chemotherapy-Induced Peripheral Neuropathy

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.).

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Izmir, Çiğli, 35620, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Registry information

Official study title

A View of Perceived Symptoms Associated with Chemotherapy-Induced Peripheral Neuropathy in Patients with Breast Cancer

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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