Heat and Cold Therapy for Chemotherapy-Induced Neuropathy
NCT06889129 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2025-07-18
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)
Interventions
- 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
-
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.
Sponsors & Collaborators
-
Bilecik Seyh Edebali Universitesi
lead OTHER
Principal Investigators
-
SABAHAT COŞKUN, Doç.Dr. · Bilecik Şeyh Edebali Üniversity
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-03
- Primary Completion
- 2025-05-10
- Completion
- 2025-07-16
Countries
- Turkey (Türkiye)
Study Locations
More Related Trials
-
Effectiveness of Cryotherapy Combined With Compression Therapy for Preventing Chemotherapy-induced Peripheral Neuropathy
NCT05341141 ·Status: RECRUITING ·Phase: NA
-
Efficacy and Safety of HILOTERM® Device for the Prevention of Peripheral Neuropathy
NCT06422949 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Preventing Taxane-related Peripheral Neuropathy, Pain and Nail Toxicity: A Prospective Self-controlled Trial Comparing Hilotherapy With Frozen Gloves in Early Breast Cancer
NCT04659980 ·Status: COMPLETED ·Phase: NA
-
Cryotherapy in Preventing Peripheral Neuropathy and Nail Toxicity in Patients With Breast Cancer Who Are Receiving Paclitaxel
NCT01243541 ·Status: TERMINATED ·Phase: NA
-
Molecular-Genetic Mechanisms Associated With Chemotherapy-Induced Nerve Damage
NCT01293851 ·Status: TERMINATED
-
The Effect of Complex Decongestive Physiotherapy on Sensory Parameters in Breast Cancer Related Lymphedema.
NCT04296929 ·Status: UNKNOWN ·Phase: NA
-
Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing Neuropathy
NCT06400849 ·Status: RECRUITING ·Phase: NA
-
Evaluation of the Effects of Using Cooling Pillowcases, on the Symptoms of Hot Flushes, Sleep and Life Quality
NCT06415162 ·Status: RECRUITING ·Phase: NA
-
Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients
NCT04256512 ·Status: COMPLETED ·Phase: NA
-
The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL
NCT03873272 ·Status: COMPLETED ·Phase: NA
-
Evaluatıon of sympathetıc Nervous System fındıngs and theır relatıonshıp wıth Symptoms ın patıents wıth Breast Cancer Related Lymphedema
NCT07019740 ·Status: COMPLETED
-
Prevention of Paclitaxel Neuropathy With Cryotherapy
NCT02230319 ·Status: UNKNOWN ·Phase: PHASE2
-
Efficacy of Auricular Acupuncture Therapy in the Prevention of CIPN in Breast Cancer
NCT07092111 ·Status: RECRUITING ·Phase: NA
-
The Use of Cryotherapy to Prevent Paclitaxel-induced Peripheral Neuropathy and Nail Changes in Women With Breast Cancer
NCT04558034 ·Status: TERMINATED ·Phase: NA
-
Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention
NCT03449303 ·Status: COMPLETED ·Phase: NA
-
The Effect of Complex Decongestıve Therapy on Oxıdatıve Stress and Antıoxıdants
NCT06572098 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Acupuncture Chemotherapy-Induced Peripheral Neuropathy (CIPN) IRG
NCT01815346 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Use of Handheld Fans in Management of Hot Flashes in Women With Breast Cancer Receiving Hormonetherapy
NCT07054957 ·Status: COMPLETED ·Phase: NA
-
Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy
NCT05642611 ·Status: RECRUITING ·Phase: PHASE3
-
PBMT for the Prevention of CIPN
NCT03391271 ·Status: COMPLETED ·Phase: NA
-
Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer
NCT02487524 ·Status: COMPLETED ·Phase: NA
-
Investigation of the Effects of Complex Decongestive Physiotherapy on Sleep Quality and Quality of Life in Women With Breast Cancer Related Lymphedema
NCT06697158 ·Status: RECRUITING ·Phase: NA
-
Photobiomodulation for Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer
NCT05663723 ·Status: COMPLETED ·Phase: NA
-
The Effect of Technological Based Rehabilitation Practices After Breast Cancer Surgery
NCT06156397 ·Status: COMPLETED ·Phase: NA
-
Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors
NCT01005108 ·Status: COMPLETED ·Phase: PHASE2