CompletedNot Applicable

Heat and Cold Therapy for Chemotherapy-Induced Neuropathy

Turkey (Türkiye)108 participantsStarted 2025-03-03

Plain-language summary

Cancer patients undergoing chemotherapy experience various side effects depending on the treatment protocol used. Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a dose-limiting and quality-of-life-reducing complication caused by chemotherapeutic agents. The development of neuropathy not only restricts patients' physical functions but may also lead to dose reduction or even the discontinuation of chemotherapy. Among chemotherapeutic agents, taxanes are among the most common causes of neuropathy. Docetaxel and paclitaxel, which belong to the taxane group, are widely used chemotherapeutics in the treatment of breast cancer. The degeneration, which manifests as numbness, tingling, and burning sensations in the fingers and toes, progresses from the distal to the proximal end of peripheral nerve axons. Although several potential agents have been clinically tested to prevent CIPN, no pharmacological agent other than duloxetine, which has limited efficacy, has been proven effective. A review of the literature reveals that non-pharmacological methods used in the management of peripheral neuropathy include transcutaneous electrical nerve stimulation (TENS), massage, exercise, heat and cold application, relaxation techniques, acupuncture, and reflexology. Studies investigating the effectiveness of local water baths in the treatment of neuropathy have reported that this approach is effective in managing neuropathic symptoms. This randomized controlled trial aims to evaluate the effects of local heat and cold application on neuropathic symptoms in breast cancer patients undergoing chemotherapy. Data will be collected using the Patient Information Form, Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT), and the Heat and Cold Application Patient Follow-up Form. Assessments will be conducted in both the intervention and control groups before the intervention and at the end of a 4-week period. This study is designed as a randomized controlled trial to determine the effects of local heat and cold application on neuropathy in patients with chemotherapy-induced peripheral neuropathy.

Who can participate

Age range18 Years – 75 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women with stage III-IV breast cancer receiving 4-7 cycles of taxane-based chemotherapy, * Patients with chemotherapy-induced neuropathy symptoms, * Residents of Ankara, * Over 18 years older, * No history of nerve damage or psychiatric illness, * No central nervous system metastasis or disease, * No irritation or ulceration in the skin area where the application will be made, * No history of deep vein thrombosis, * Not using anticoagulant medication, * Able to speak, understand, and read/write in Turkish, * Patients who consent to participate in the study will be included. Exclusion Criteria * Patients with a history of nerve damage or psychiatric illness, * Ulcers or irritation in the area where the application will be made, * Patients with peripheral neuropathy developed due to reasons other than chemotherapy, * Patients who do not consent to participate in the study will be excluded. Exclusion Criteria During the Study * Patients whose taxane treatment protocol is changed, * Patients who have less than four applications per week will be excluded from the study.

What they're measuring

1. Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)

Timeframe: At baseline (first visit) and at 4 weeks

Local Heat and Cold Application Patient Follow-up Form

Timeframe: At baseline (first visit) and at 4 weeks

Trial details

NCT IDNCT06889129

SponsorBilecik Seyh Edebali Universitesi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-10