Heat and Cold Therapy for Chemotherapy-Induced Neuropathy

Effect of Local Heat and Cold Application in the Management of Peripheral Neuropathy in Breast Cancer Patients Receiving Chemotherapy: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-Induced Peripheral Neuropathy (CIPN)
• Intervention / Treatment: Other: Experimental- Heat application; Other: Experimental-Cold application

Detailed Description

Breast cancer patients undergoing chemotherapy experience various side effects depending on the treatment protocol used. The most common side effects include neutropenia, anemia, peripheral neuropathy, nausea, vomiting, diarrhea, constipation, and fatigue. Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a dose-limiting and quality-of-life-reducing complication caused by chemotherapeutic agents. CIPN can develop either during or after chemotherapy and not only restricts patients' physical functions but may also lead to dose reduction or even treatment discontinuation.

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 incidence of taxane-induced peripheral neuropathy varies between 61% and 92%. Although taxane-induced neuropathy primarily presents with sensory symptoms, it is a toxicity that can also affect motor and autonomic functions. 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. Neuropathy in the upper extremities typically appears later.

The neurotoxicity of taxane-induced neuropathy is dose-dependent, and progression ceases once the drug treatment is completed. Emerging symptoms can be prevented by reducing the drug dose or increasing the interval between doses. However, these adjustments may significantly compromise cancer treatment outcomes. Although numerous potential agents have been clinically tested to prevent chemotherapy-induced peripheral neuropathy, 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. Medical baths have been used in the treatment of inflammatory and non-inflammatory rheumatic diseases, fibromyalgia, and chronic back pain, as well as for reducing fatigue and improving sleep regulation. In particular, foot bath studies have reported that foot baths increase blood circulation through vasodilation in peripheral blood vessels, improve sensory symptoms, stimulate the sense of touch, reduce sympathetic nerve activity, enhance skin permeability, promote microcirculation in cells, and support drug therapy.

A review of the literature indicates that very few studies have investigated the effects of foot baths on the management of peripheral neuropathy in cancer patients. Studies examining the effectiveness of local water baths in the treatment of neuropathy have reported that this approach is an effective strategy for managing neuropathic symptoms

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06010
    • Gulhane Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; standard protocol=Patients in this arm will receive standard care without any additional interventions related to heat or cold application.
Experimental: Intervention group; Cold-Heat application + standard protocol	Other: Experimental- Heat application; Heat application + standard protocol=Hot Application Protocol Hot application will start daily and continue until the completion of 4 weeks. The area will be checked for infection, scar tissue, inflammation, and incision before the application, and the procedure will be explained to the patient and their family. The first application will be performed on the day the patient comes for chemotherapy, ensuring privacy by exposing only the application area and positioning the patient appropriately. Patients will be asked to sit on a chair or couch with both feet immersed in a foot bath containing 5 liters of water, approximately 5 cm above their ankles, every night before bed for one month. The water temperature will be 40°C. The application will last for 30 minutes. Patients will be advised to avoid contact with cold water, as well as the consumption of cold food and beverages.; Other Names: Heat application; Other: Experimental-Cold application; Cold application + standard protocol=Cold application will start daily and continue until the completion of 4 weeks. The area will be checked for infection, scar tissue, inflammation, and incision before the application, and the procedure will be explained to the patient and their family. The first application will be performed on the day the patient comes for chemotherapy, ensuring privacy by exposing only the application area and positioning the patient appropriately. Patients will be asked to sit on a chair or couch with both feet immersed in a foot bath containing 5 liters of water, approximately 5 cm above their ankles, every night before bed for one month. The water temperature will be between 23-26°C. The application will be performed by the researcher on the day the patient comes for weekly chemotherapy treatment. Patients will be advised to avoid contact with hot water, as well as the consumption of hot food and beverages.; Other Names: Cold application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)	The Turkish validity and reliability of the scale were tested in breast cancer patients receiving taxane chemotherapy (n=430). The first section assesses sensory and motor symptoms (numbness, itching, burning, discomfort, cold sensitivity, pain, weakness, balance problems), with responses scored from 0 to 10. Higher scores indicate greater discomfort. In the second section, difficulties in daily activities (e.g., dressing, walking, working, exercising) are also rated from 0 to 10. The scale's overall Cronbach alpha is 0.87, with test-retest reliability ranging from 0.90 to 0.96. These results confirm that the scale is valid and reliable for the Turkish population.	At baseline (first visit) and at 4 weeks
Local Heat and Cold Application Patient Follow-up Form	This form is designed to assess patients' adherence to local heat or cold application. During the heat or cold application process, patients will be followed up by phone to enhance their adherence to the program and ensure compliance. In addition, when patients come to receive their weekly chemotherapy doses, the application will be performed by the researcher. Patients will mark their heat or cold application status on the form while performing the application at home. The forms will be reviewed by the researcher when patients visit the hospital for chemotherapy treatment. Patients who perform the application less than four times per week will not be included in the evaluation.	At baseline (first visit) and at 4 weeks

Collaborators and Investigators

• Sponsor: Bilecik Seyh Edebali Universitesi
• Investigators: Study Director: SABAHAT COŞKUN, Doç.Dr., Bilecik Seyh Edebali University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Actual): May 10, 2025
• Study Completion (Actual): July 16, 2025

Study Registration Dates

• First Submitted: March 15, 2025
• First Submitted That Met QC Criteria: March 15, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: breast cancer; Chemotherapy-Induced Peripheral Neuropathy (CIPN); Heat-cold application; Non-pharmacological methods
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: Bilecik16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be shared upon request, in accordance with ethical guidelines and with participant consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No