Breast Cancer Clinical Trial
Official title:
Investigation of the Effect of Chemotherapy-induced Peripheral Neuropathy (CIPN) on Sensory and Motor Function in Patients With Cancer
NCT number | NCT04799080 |
Other study ID # | BakircayU/D208 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 6, 2021 |
Est. completion date | May 15, 2022 |
Verified date | March 2024 |
Source | Izmir Bakircay University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
As cancer survival rates have been increased due to technological developments and early detection strategies, there has been been a growing need to assess the effect of long-term complications and adverse effects upon patients' functionality and quality of life. Chemotherapy, which is accepted to be the body of systemic adjuvant therapy is attributed to long-term survival, yet some side effects such as sarcopenia, loss of muscle strength and functional capacity, fatigue, and sensory disturbances due to the neurotoxic effects have been well known. Chemotherapy-induced peripheral neuropathy (CIPN) is a condition that is characterized by main loss of cutaneous sensation especially in the distal part of the extremities. CIPN affects approximately 30-40% of patients with cancer undergoing chemotherapy. Loss of sensation in distal sides of upper and lower extremities may cause not only deterioration of fine hand skills but also loss of balance and thereby one's mobility and independence are detrimentally affected. Thus, this study is aimed to assess CIPN in patients with cancer undergoing chemotherapy in a longitudinal design by assessing the cutaneous function of the sensory nerves and related effect of motor function.
Status | Completed |
Enrollment | 72 |
Est. completion date | May 15, 2022 |
Est. primary completion date | March 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Being a Volunteer to participate this study - Having diagnosed with Cancer - Having available to be implemented to adjuvant systemic chemotherapy application Exclusion Criteria: - Prior diagnosed with diabetic polyneuropathy - Neo-adjuvant chemotherapy - Having scar tissue in the palmar and/or plantar side(s) of the skin might affect the sensory evaluation - Having Multiple Sclerosis or other neurological diseases which might affect neural conductivity disturbances and/or sensory loss |
Country | Name | City | State |
---|---|---|---|
Turkey | Bakircay University Çigli State and Training Hospital, Department of Medical Oncology | Izmir | Çigli |
Lead Sponsor | Collaborator |
---|---|
Izmir Bakircay University |
Turkey,
Quasthoff S, Hartung HP. Chemotherapy-induced peripheral neuropathy. J Neurol. 2002 Jan;249(1):9-17. doi: 10.1007/pl00007853. — View Citation
Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23. — View Citation
Staff NP, Grisold A, Grisold W, Windebank AJ. Chemotherapy-induced peripheral neuropathy: A current review. Ann Neurol. 2017 Jun;81(6):772-781. doi: 10.1002/ana.24951. Epub 2017 Jun 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hand Grip Strength | Motor Function Asssesment via Hand-Grip Strength | 6 weeks | |
Primary | Minnesota Rate of Manipulation Test | Functional Assessment of Hands | 6 weeks | |
Primary | Semmens Weinstein Monofilament Test (SWMT) | Evaluation of Cutaneous Sensory Function | 6 weeks | |
Secondary | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) | Quality of Life Questionnaire | 6 weeks | |
Secondary | Functional Assessment of Cancer Therapy-Breast (FACT-B+) | Health Related Quality of Life Assessment | 6 weeks |
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