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Completed
NCT06879678
Web-Based Exercise for Neuropathy and Quality of Life in Breast Cancer
Conditions: Chemotherapy-Induced Peripheral Neuropathy (CIPN), Breast Cancer
Sex: Female
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 95
Sponsor: Bilecik Seyh Edebali Universitesi
Location: Gulhane Education and Research Hospital, Ankara, 06010 Ankara
Summary
Chemotherapy is a widely used treatment method for cancer patients. However, various side effects may occur depending on the drug used, treatment duration, and dosage. One of these side effects is chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a common complication that negatively affects patients' quality of life due to nerve damage.
In particular, taxane-based chemotherapy drugs (e.g., docetaxel and paclitaxel), which are commonly used in the treatment of breast cancer, can lead to peripheral neuropathy. Studies indicate that the incidence of taxane-induced neuropathy ranges between 61% and 92%. While this condition primarily presents with sensory symptoms, it can also affect motor and autonomic nervous system functions in some patients.
Currently, pharmacological treatments for preventing CIPN are limited. Aside from duloxetine, no medication has been proven effective. Therefore, non-pharmacological approaches, such as exercise, are considered an important alternative for alleviating neuropathy symptoms.
Exercise is emerging as an effective method for preventing and managing peripheral neuropathy during cancer treatment. Research suggests that regular exercise has positive effects on the nervous system and can help reduce neuropathic symptoms, thereby improving patients' quality of life.
This randomized controlled trial aims to evaluate the effects of a web-based exercise program on neuropathic symptoms and quality of life in breast cancer patients undergoing chemotherapy. The study consists of two phases: In the first phase, a web-based exercise program will be developed under the guidance of a physiotherapist to help manage neuropathic symptoms. In the second phase, the effectiveness of this program will be assessed. Data will be collected using the Patient Information Form, Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT), and the EORTC QLQ-C30 Quality of Life Questionnaire. Evaluations will be conducted before the intervention and at the end of an 8-week period in both the intervention and control groups.
This study aims to demonstrate the potential effects of web-based exercise programs in alleviating neuropathic symptoms and improving quality of life in cancer patients.
Eligibility Criteria
Inclusion Criteria:
* Able to understand and speak Turkish,
* Over 18 years of age,
* Receiving taxane-based chemotherapy in daytime chemotherapy units,
* Reporting at least one neuropathy symptom according to CIPNAT,
* Diagnosed with stage II-III breast cancer,
* Receiving a planned weekly taxane-based chemotherapy infusion dose (70-99 mg/m², 100-129 mg/m², 130-159 mg/m², 160 mg/m² and above) and completing 8 treatment cycles,
* Having internet access,
* No history of deep vein thrombosis,
* Not using anticoagulant medication,
* Willing to participate in the study.
Exclusion Criteria:
* Younger than 18 years or older than 75 years,
* Having central nervous system disorders affecting movement, balance, sensation, or coordination,
* Presence of any skin infection, scar tissue, inflammation, or incision on the hands or ankles,
* Diagnosed with a proven cardiac condition or using medication for cardiac issues,
* Pregnant women or those in the postpartum period,
* History of polyneuropathy before chemotherapy,
* Cognitive impairment,
* Presence of metal implants in the exposure area,
* History of any other malignancy,
* Undergoing mastectomy.
Withdrawal Criteria
* Patients meeting the following conditions will be withdrawn from the study:
* Patients whose taxane treatment protocol is changed,
* Patients who wish to withdraw from the study,
* Patients with a pulse rate above 100 bpm,
* Patients receiving fewer than four weekly chemotherapy applications,
* Women without internet access or those who do not visit the website at least five times for four hours throughout the follow-up period.
Source: ClinicalTrials.gov (NCT06879678). StuddyBuddy aggregates publicly available trial information.