Clinical trial NCT06889129: Heat and Cold Therapy for Chemotherapy-Induced Neuropathy
Official title: Effect of Local Heat and Cold Application in the Management of Peripheral Neuropathy in Breast Cancer Patients Receiving Chemotherapy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Keywords: Chemotherapy-Induced Peripheral Neuropathy (CIPN)
breast cancer
Heat-cold application
Non-pharmacological methods
Lead sponsor: Bilecik Seyh Edebali Universitesi
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: 1. Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)
timeFrame: At baseline (first visit) and at 4 weeks
measure: Local Heat and Cold Application Patient Follow-up Form
timeFrame: At baseline (first visit) and at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Education and Research Hospital
Study officials:
affiliation: Bilecik Şeyh Edebali Üniversity
name: SABAHAT COŞKUN, Doç.Dr.
role: STUDY_DIRECTOR
References: