- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07650864
The Effect of Foot Massage With a Massage Roller on Chemotherapy-Related Neuropathic Pain
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Erzurum
-
Erzurum, Erzurum, Turkey (Türkiye), 25080
- Atatürk Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
(1) age ≥18, (2) receiving neurotoxic chemotherapy regimens including Taxanes (Paclitaxel/Docetaxel), Platinum (Carboplatin/Cisplatin), or a combination of both, (3) Having completed at least three cycles of chemotherapy, (4) scoring ≥ 12 on the S-LANSS scale, and ≥ 4 on the VAS, (5) being conscious, cooperative, and able to communicate in Turkish (6) volunteering to participate and providing written informed consent.
Exclusion Criteria:
(1) peripheral neuropathy pre-dating the chemotherapy (e.g., diabetic, alcoholic, or nutritional neuropathy) (2) receiving non-taxane/non-platinum regimens or Oxaliplatin-based chemotherapy, (3) active skin infections, open wounds, or severe scar tissue on the feet, (4) history of deep vein thrombosis or active bone/spine metastases in the lower extremities, (5) comorbidities affecting the sensory function of the nervous system.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: wooden massage roller
|
intervention group
|
|
Active Comparator: ıce therapy
|
control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale- Pain score
Time Frame: 3 weeks
|
The Visual Analogue Scale (VAS), developed by Price et al. (1983), was utilized to assess and monitor pain intensity; it is a simple, repeatable, and widely used subjective method for rapid pain assessment [24].
In this method, participants marke their perceived pain on a 10 cm ruler, where 0 represent "no pain", and 10 represent 'the most severe or imaginable pain".
In this study, pain intensity was categorized as 4 for "mild pain", 5-6 for "moderate pain", and 7-10 for "severe pain".
|
3 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Neuralgia
- Environment and Public Health
- Inorganic Chemicals
- Environment
- Ecological and Environmental Phenomena
- Biological Phenomena
- Weather
- Meteorological Concepts
- Anions
- Ions
- Electrolytes
- Hydroxides
- Alkalies
- Oxides
- Oxygen Compounds
- Water
- Ice
Other Study ID Numbers
- TSA-2025-16152
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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