Symptoms Associated with Chemotherapy-Induced Peripheral Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-18

Study Completion Date

2024-08-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Chemotherapy-induced Peripheral Neuropathy Breast Cancer Breast Cancer Female

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

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

Intervention Type 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

Interventions

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

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

Intervention Type OTHER

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No