Symptoms Associated With Chemotherapy-Induced Peripheral Neuropathy

Status Recruiting

Clinical Trial Summary

Breast cancer remains the most frequent type of cancer globally. Nevertheless, the increased rate of disease-free survival of breast cancer brought the specific need of managing of short and long-term side effects of multimodal treatment. Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating conditions which is characterized by a wide variety of experienceable symptoms by patients that need to be addressed in detail. Therefore, in this cross-sectional study, it was aimed to assess the potential symptoms associated with CIPN of patients with breast cancer who underwent systemic chemotherapy. In addition, it was aimed to assess the potential associations between experienced symptoms of CIPN and sociodemographic (age, body mass index etc.) and clinical features (mean exposed dose, type of surgery (if any) etc.).

Clinical Trial Description

Patients with breast cancer who underwent systemic chemotherapy were assessed with the European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire within 1-2 months after completion of systemic chemotherapy. A simple data form was implemented in which patients' age, weight, height, marital status, smoking status, etc were investigated. In addition, the dose of the exposure of systemic chemotherapy was calculated according to the Body Surface Area (BSA) and DuBois formulation as follows: BSA [m2] = Weight [kg]0.425 × height (cm)0.725 × 0.007184]. The universal dose calculations were used to calculate the mean exposure according to the following doses for each patient-specific to their chemotherapy regimen: Four cycles of Anthracycline were applied 14 days apart 60 mg/m2 intravenous (IV), 12 cycles of Paclitaxel were applied seven days apart 80 mg/m2 IV, and four cycles of Docetaxel were applied 21 days apart 75 mg/m2 IV. ;

Study Design

Related Conditions & MeSH terms

Breast Cancer
Breast Cancer Female
Breast Neoplasms
Chemotherapy-induced Peripheral Neuropathy
Peripheral Nervous System Diseases

Clinical Trial Details

NCT number	NCT06352567
Study type	Observational
Source	Izmir Bakircay University
Contact	Alper Tugral, Ph.D.
Phone	+9050474421420
Email	alper.tugral@bakircay.edu.tr
Status	Recruiting
Phase
Start date	January 18, 2024
Completion date	August 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04681911` - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer	Phase 2
Terminated	`NCT04066790` - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer	Phase 2
Completed	`NCT04890327` - Web-based Family History Tool	N/A
Completed	`NCT03591848` - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility	N/A
Recruiting	`NCT03954197` - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients	N/A
Terminated	`NCT02202746` - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer	Phase 2
Active, not recruiting	`NCT01472094` - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Withdrawn	`NCT06057636` - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study	N/A
Completed	`NCT06049446` - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting	`NCT05560334` - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations	Phase 2
Active, not recruiting	`NCT05501769` - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer	Phase 1
Recruiting	`NCT04631835` - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer	Phase 1
Completed	`NCT04307407` - Exercise in Breast Cancer Survivors	N/A
Recruiting	`NCT03544762` - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation	Phase 3
Terminated	`NCT02482389` - Study of Preoperative Boost Radiotherapy	N/A
Enrolling by invitation	`NCT00068003` - Harvesting Cells for Experimental Cancer Treatments
Completed	`NCT00226967` - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT06037954` - A Study of Mental Health Care in People With Cancer	N/A
Recruiting	`NCT06019325` - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.