Heat and Cold Therapy for Chemotherapy-Induced Neuropathy

NCT06889129 | Completed

• 1 other identifier: Bilecik16
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Keywords

Chemotherapy-Induced Peripheral Neuropathy (CIPN); breast cancer; Heat-cold application; Non-pharmacological methods

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control group

NO INTERVENTION

standard protocol=Patients in this arm will receive standard care without any additional interventions related to heat or cold application.

Intervention group

EXPERIMENTAL

Cold-Heat application + standard protocol

Other: Experimental- Heat application; Other: Experimental-Cold application

Interventions

Experimental- Heat application OTHER

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.

Also known as: Heat application

Intervention group

Experimental-Cold application OTHER

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.

Also known as: Cold application

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients whose taxane treatment protocol is changed,
• Patients who have less than four applications per week will be excluded from the study.

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

Study Sites (1)

Gulhane Education and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• SABAHAT COŞKUN, Doç.Dr.

  Bilecik Şeyh Edebali Üniversity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Model Details: The study population will consist of breast cancer patients receiving taxane-based chemotherapy at the Daytime Chemotherapy Unit of a training and research hospital who meet the inclusion criteria. The sample size calculation was performed for the study. Before conducting the power analysis, the effect size needed to be determined. In this study, the effect size was derived from a similar previous study. Considering a Type I error (α) = 0.05 and Power (1-β) = 0.90, the effect size (d) was selected as 0.35 based on a one-way analysis of variance (ANOVA). Using G\*Power 3.1.9.7, the minimum required sample size was calculated as 108 participants. Based on these parameters, the expected minimum sample size is 36 patients per group, with a total of 108 participants. However, considering potential dropouts during the study, a total of 114 patients are planned to be included.

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 21, 2025
• Study Start: March 3, 2025
• Primary Completion: May 10, 2025
• Study Completion: July 16, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)