None listed
Conditions
Brief summary
Brief description of the study purpose The COMPRES study aims to test whether wearing compression gloves and stockings during oxaliplatin chemotherapy is feasible, safe, and may help reduce chemotherapy related nerve damage (peripheral neuropathy) in patients with gastrointestinal cancers. Who is it for? You may be eligible for this study if you are male or female, aged 18 years and older with gastrointestinal cancers who are scheduled to receive oxaliplatin based chemotherapy, are well enough to participate, and are willing to provide informed consent. Study details Those who choose to participate will wear compression gloves (two surgical gloves per hand) and lower limb compression stockings starting 30 minutes before chemotherapy, during the infusion, and for 30 minutes after each oxaliplatin treatment, for a minimum of 12 weeks. This is a non randomised study, meaning all participants will receive the compression intervention during their routine chemotherapy care. Participants will complete questionnaires about nerve symptoms, comfort, and quality of life, and clinical information about side effects and any treatment changes will be collected. No additional blood tests are required beyond standard cancer care. It is help the results from this study will help determine whether a simple, low cost intervention can safely reduce oxaliplatin related peripheral neuropathy and support better quality of life for patients receiving chemotherapy.
Interventions
This study is testing whether wearing compression garments—surgical gloves and compression stockings—can help reduce nerve damage (neuropathy) in patients receiving oxaliplatin chemotherapy for gastrointestinal cancers. The aim is to determine if patients can safely tolerate the compression garments and if wearing the garments can help reduce nerve damage (neuropathy) in patients receiving oxaliplatin chemotherapy for gastrointestinal cancers.
The study is non-randomised, which means patients
This study is testing whether wearing compression garments—surgical gloves and compression stockings—can help reduce nerve damage (neuropathy) in patients receiving oxaliplatin chemotherapy for gastrointestinal cancers. The aim is to determine if patients can safely tolerate the compression garments and if wearing the garments can help reduce nerve damage (neuropathy) in patients receiving oxaliplatin chemotherapy for gastrointestinal cancers. The study is non-randomised, which means patients are not randomly assigned to groups. All participants will receive the compression therapy while having their oxaliplatin-based chemotherapy. The goal is to see if this simple method can safely and effectively manage one of the common side effects of oxaliplatin- peripheral neuropathy. Participants will wear compression gloves (two surgical gloves per hand) and lower-limb compression stockings beginning 30 minutes before, during, and for 30 minutes after each oxaliplatin infusion. Oxaliplatin is typically administered every 2–3 weeks, depending on the chemotherapy regimen. The compression intervention will be used for a minimum of 12 weeks of treatment (approximately four to six cycles), unless oxaliplatin is discontinued earlier. Follow-ups will occur 12 and 24 weeks after end of oxaliplatin treatment.
Sponsors
Icon Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who meet all of the following criteria are eligible for enrolment onto the study. 1. Male or female patients aged 18 years or older 2. Patients with gastrointestinal malignancies who are scheduled to receive oxaliplatin containing regimens, oxaliplatin 85mg/m2 every 2 weeks or 130 mg/m2 every 3 weeks, for at least 12 weeks 3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 4. Willing and able to provide informed consent
Exclusion criteria
Patients who meet any of the following criteria are not eligible for enrolment onto the study. 1. Current grade 2 or higher peripheral neuropathy. Patients with high risk for OIPN based on previous (neurotoxic) chemotherapy or diabetes mellitus are eligible provided they have grade 0 or 1 peripheral neuropathy at the time of inclusion. 2. Symptomatic peripheral vascular disease or peripheral arterial ischemia precluding use of compression garments 3. Allergy to natural rubber, latex, or surgical gloves 4. Dermatopathy, wound, or musculoskeletal problems of the hands at enrolment that would prevent safe application of compression garments 5. Taking current medications that may mitigate CIPN, including duloxetine, gabapentin/pregabalin, ketamine and tricyclic antidepressants 6. Unable or unwilling to comply with protocol requirements.
Outcome results
None listed