Chemotherapy-induced Peripheral Neuropathy (CIPN) on Motor and Sensory Function

NCT04799080 | Completed

• 1 other identifier: BakircayU/D208
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Chemotherapy-induced Peripheral Neuropathy; Chemotherapeutic Toxicity; Breast Cancer; Breast Neoplasms; Colon Neoplasm; Colo-rectal Cancer

Keywords

Chemotherapy-induced Peripheral Neuropathy; Hand Grip; Cutaneous; Quality of Life

Outcome Measures

Primary Outcomes (3)

• Hand Grip Strength

  Motor Function Asssesment via Hand-Grip Strength

  6 weeks

• Minnesota Rate of Manipulation Test

  Functional Assessment of Hands

  6 weeks

• Semmens Weinstein Monofilament Test (SWMT)

  Evaluation of Cutaneous Sensory Function

  6 weeks

Secondary Outcomes (2)

• The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)

  6 weeks

• Functional Assessment of Cancer Therapy-Breast (FACT-B+)

  6 weeks

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with cancer especially with colon, colorectal, and breast who will undergo a systemic adjuvant chemotherapy implementation.

You may qualify if:

• Being a Volunteer to participate this study
• Having diagnosed with Cancer
• Having available to be implemented to adjuvant systemic chemotherapy application

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Bakircay University Çiğli State and Training Hospital, Department of Medical Oncology

Izmir, Çiğli, 35620, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 28486769 BACKGROUND

• 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.

  PMID: 25261162 BACKGROUND

• Quasthoff S, Hartung HP. Chemotherapy-induced peripheral neuropathy. J Neurol. 2002 Jan;249(1):9-17. doi: 10.1007/pl00007853.

  PMID: 11954874 BACKGROUND

• Tugral A, Aribas Z, Akyol M, Bakar Y. Assessment of sensorimotor and strength related function of breast cancer patients during systemic drug therapy: a prospective observational study. BMC Cancer. 2023 Oct 14;23(1):981. doi: 10.1186/s12885-023-11494-x.

  PMID: 37838686 DERIVED

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Murat Akyol, MD

  Bakircay University Faculty of Medicine Department of Internal Medicine, Medical Oncology unit

  PRINCIPAL INVESTIGATOR

• Zeynep Arıbaş, PT

  Bakircay University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Alper Tuğral, PT, MSc

  Bakircay University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Yeşim Bakar, PT, Prof

  Bakircay University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: March 6, 2021
• Primary Completion: March 15, 2022
• Study Completion: May 15, 2022
• Last Updated: April 1, 2024

Record last verified: 2024-03

Locations

TU (1)