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 range

18 Years – 75 Years

Sex

FEMALE

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Chemotherapy-Induced Peripheral Neuropathy (CIPN) trials