Colon Cancer, Oxaliplatin-induced Peripheral Neuropathy
Conditions
Keywords
oxaliplatin-induced peripheral neuropathy, Peripheral Neuropathy, Oxaliplatin, Surgical Gloves, Body Mass Index (BMI), Sarcopenia
Brief summary
The primary objective of this randomized clinical trial is to assess whether the use of surgical gloves during treatment can prevent the occurrence of oxaliplatin-induced peripheral neuropathy.
Detailed description
Gastrointestinal tumors account for one-quarter of the global cancer incidence and one-third of cancer-related deaths. Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of oxaliplatin-based treatments. CIPN can lead to an extremely painful and debilitating process, causing significant loss of functional abilities and negatively affecting the quality of life of these patients, as well as activities of daily living (ADLs) such as walking, buttoning clothes, writing, brushing teeth, among others. This condition can even result in a state of vulnerability, with a high risk of falls and other injuries. Primary Objective and Study Rationale: Oxaliplatin, widely used to treat patients with colorectal neoplasms, is associated with chemotherapy-induced peripheral neuropathy (CIPN). Given the high prevalence and negative impact of CIPN on quality of life and adherence to cancer treatment, there is a significant gap in identifying effective prevention and management strategies. Although recent evidence suggests that surgical gloves (SG) can mitigate paclitaxel-induced peripheral neuropathy, SGs have not been tested for the prevention of oxaliplatin-induced peripheral neuropathy (OIPN). Therefore, the primary objective of this randomized clinical trial is to evaluate whether the use of SGs during treatment can prevent the occurrence of grade 2 or higher OIPN in the hands, as assessed by CTCAE v5.0 and PRO-CTCAE. Secondary Objective: To determine the relationship between Body Mass Index and the presence of sarcopenia, with the occurrence of OIPN; To evaluate the impact of OIPN on patients' health-related quality of life (HRQoL) using the EORTC QLQ-C30 questionnaire; To assess symptoms and functional limitations associated with OIPN using the EORTC QLQ-CIPN20 questionnaire.
Interventions
DEVICESurgical Gloves
During each chemotherapy cycle, patients in the experimental group will wear compressive surgical gloves (one size smaller than recommended based on palmar surface measurement) on both hands, which will be put on 30 minutes before the infusion and remain in place until 30 minutes after the end of the chemotherapy infusion.
Sponsors
Hospital do Cancer de Londrina
AC Camargo Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This study is a prospective, open-label, randomized, controlled, multicenter clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years or older who have provided written informed consent. * Colon adenocarcinoma with high-risk stage III (pT4pN2) or stage IV. * Oxaliplatin-based treatment in the context of localized or metastatic disease. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Exclusion criteria
* Pre-existing neuropathy. * Uncontrolled diabetes. * known glove allergies. * Prior treatment with paclitaxel, docetaxel or oxaliplatin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxaliplatin-Induced Peripheral Neuropathy | Baseline, 2 months, 4 months and 6 months | The primary objective of this randomized clinical trial is to evaluate whether the use of surgical gloves during treatment can prevent the occurrence of grade 2 or higher oxaliplatin-induced peripheral neuropathy in the hands, as assessed by CTCAE v5.0 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sarcopenia assessing by muscle strength, muscle quantity/quality, and physical performance, Body Mass Index (BMI) evaluated by a mathematical formula (kg/m2). | Baseline, 2 months, 4 months and 6 months | To determine the relationship between BMI and the presence of sarcopenia, with the occurrence of oxaliplatin-induced peripheral neuropathy (OIPN); |
| Health-related Quality of life questionaries | Baseline, 2 months, 4 months and 6 months | To evaluate the impact of OIPN on patients' health-related quality of life (HRQoL) using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30). For the Functional Scales, higher scores indicate better functioning (0=poorest ; 100=best). For the Symptom Scales, higher scores indicate greater symptom severity (0=no symptoms; 100=severe). For the Global Health Status/Quality of Life Scale, higher scores reflect a better overall perception of health and quality of life (0=poorest; 100=best). |
| Functional limitations associated with OIPN | Baseline, 2 months, 4 months and 6 months | To assess symptoms and functional limitations associated with OIPN using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CIPN20). All scores are transformed into a standardized 0-100 scale, with higher scores indicating severe symptoms. |
| Patient reported Peripheral Neuropathy | Baseline, 2 months, 4 months and 6 months | Patient reported Oxaliplatin-Induced Peripheral Neuropathy assessed by PRO- CTCAE. |
Countries
Brazil
Contacts
Primary ContactVirgilio Souza Silva, Medical Doctor, PhD
Backup ContactÉverton Germano Melo, Medical Doctor
Outcome results
None listed