Chemotherapy-induced Peripheral Neuropathy Clinical Trial
Official title:
CROPSI Study A Randomized, Observer-blinded Clinical Trial Evaluating Effectiveness of Cryotherapy vs. Cryocompression for Preventing CIPN in Women Undergoing Chemotherapy
This study's aim is to show a benefit of Cryocompression (cooling hands with additional compression of the hands) in comparison to Cryotherapy (just cooling hands) in female cancer patients (with gynecological cancer) receiving chemotherapy with taxanes. Patients who are not eligible for either cryocompression or cryotherapy are included in a control group. The expected benefits with additional compression to the cryotherapy are reduction of chemotherapy induced polyneuropathy and reduced nail changes.
Status | Recruiting |
Enrollment | 196 |
Est. completion date | February 3, 2024 |
Est. primary completion date | February 3, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Patients with breast cancer or other gynecological tumors - planned neoadjuvant, adjuvant or palliative chemotherapy - </= two lines chemotherapy as pre-therapy (adjuvant chemotherapy counts as one line) - at least three cycles of chemotherapy with taxanes - written consent - 18 years and older Exclusion Criteria: - PNP >/= 2 - neuralgia - metastases in bones, metastases in soft tissue (located in skin, hands or feet) - Raynaud syndrome - peripheral arterial ischemia - hand-feet syndrome |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Innsbruck | Innsbruck | Tirol |
Lead Sponsor | Collaborator |
---|---|
Medical University Innsbruck |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NCV (nerve conduction velocity) | Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of = CIPN III° | 4 years | |
Primary | CTCAE 4.03 | Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of = CIPN III° | 4 years | |
Primary | SWME (Semmes Weinstein monofilament examination) | Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of = CIPN III° | 4 years | |
Primary | tuning-fork-test | Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of = CIPN III° | 4 years | |
Primary | EORTC QoLCIPN20 | Patient-reported outcomes (PRO) | 4 years | |
Primary | Neuro-QoL Domain for Upper Extremity (FineMotor, ADL) | Patient-reported outcomes (PRO) | 4 years | |
Secondary | National Cancer Institute Common Toxicity Criteria version 2 | Changes of nails | 4 years | |
Secondary | time frame until polyneuopathy occurs | time frame until polyneuopathy occurs whilst receiving Taxanes | 4 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05528263 -
Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial)
|
N/A | |
Completed |
NCT03272919 -
Chemotherapy Induced Peripheral Neuropathy (CIPN)
|
N/A | |
Not yet recruiting |
NCT06430814 -
Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
|
||
Not yet recruiting |
NCT05840562 -
Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy
|
Phase 3 | |
Completed |
NCT02553863 -
The Effectiveness and Cost-effectiveness of Acupuncture in Managing Chemotherapy-induced Peripheral Neuropathy
|
N/A | |
Recruiting |
NCT04786977 -
Physiologic Measure of VIPN
|
||
Completed |
NCT03655587 -
Impact of an Orthotic Intervention in Children With Peripheral Neuropathy
|
N/A | |
Completed |
NCT03687970 -
A New Method for Identifying Sensory Changes in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN)
|
N/A | |
Terminated |
NCT04770402 -
Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients
|
N/A | |
Completed |
NCT03254394 -
Lidocaine for Oxaliplatin-induced Neuropathy
|
Phase 1/Phase 2 | |
Completed |
NCT04367480 -
Effects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-Induced Peripheral Neuropathy
|
N/A | |
Recruiting |
NCT04237194 -
A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy
|
||
Completed |
NCT04843410 -
Effect of Exercise in the Management of Peripheral Neuropathy
|
N/A | |
Terminated |
NCT03782402 -
Cannabinoids for Taxane Induced Peripheral Neuropathy
|
Phase 2 | |
Not yet recruiting |
NCT06389721 -
Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy
|
||
Recruiting |
NCT05121558 -
The Effect of Yoga on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
|
Phase 3 | |
Withdrawn |
NCT04492436 -
A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo
|
Phase 2 | |
Not yet recruiting |
NCT03112057 -
Visualize Nociceptor Changes in Neuropathic Human
|
N/A | |
Completed |
NCT04262778 -
Diagnostic of Chemotherapy Induced Neuropathy in Children
|
||
Recruiting |
NCT06324344 -
Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN)
|
N/A |