Trial comparing treatments for Malignant Solid Neoplasm
Official title Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy
ClinicalTrials.gov ID: NCT05642611
What this study is testing
- What it's testing
- The study compares cryocompression, continuous compression, and low cyclic compression to see if any can stop or lessen peripheral neuropathy caused by taxane drugs like paclitaxel or docetaxel.
- Who it's for
- Adults with a malignant solid tumor who will receive taxane chemotherapy.
- What's involved
- Participants will wear a Paxman Limb Cryocompression System on their arms and legs during treatment. The device either cools, compresses, or does both in different ways depending on the group.
- Time commitment
- The study lasts for the duration of the chemotherapy cycle, with visits to apply the device and monitor symptoms as scheduled by the treatment plan.
- Phase 3: a large, late-stage study
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have a diagnosis of a solid tumor malignancy.
- Participants must be planning to begin neoadjuvant or adjuvant therapy with one of the protocol-specified chemotherapy regimens below for a solid...
- Weekly paclitaxel x 12 consecutive weeks
- Weekly paclitaxel x 12 consecutive weeks + carboplatin (weekly x 12 consecutive weeks or every 3 weeks x 4 consecutive cycles)
- Paclitaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery
You likely can't join if
- Participants must not have a history of skin or limb metastases.
- Participants must not have previously received neurotoxic chemotherapy for any reason (e.g., taxanes, platinum agents, vinca alkaloids, or...
- Participants must not have pre-existing clinical peripheral neuropathy from any cause.
- Participants must not have a history of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold...
- Participants must not have any open skin wounds or ulcers of the limbs at the time of randomization.
See the full eligibility criteria
- Participants must have a diagnosis of a solid tumor malignancy.
- Participants must be planning to begin neoadjuvant or adjuvant therapy with one of the protocol-specified chemotherapy regimens below for a solid tumor malignancy within 3 calendar days after randomization.
- Weekly paclitaxel x 12 consecutive weeks
- Weekly paclitaxel x 12 consecutive weeks + carboplatin (weekly x 12 consecutive weeks or every 3 weeks x 4 consecutive cycles)
- Paclitaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery
- Docetaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery NOTE: For any of the protocol-specified chemotherapy regimens, concurrent targeted therapy with biologic therapy is...
- Participant must be \>= 18 years old.
- Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System.
- Participants must be able to complete Patient-Reported Outcome (PRO) questionnaires in English or Spanish.
- Participants must 1) agree to complete PROs at all scheduled assessments, and 2) complete the baseline PRO questionnaires within 14 days prior to randomization
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
- Participants must not have a history of skin or limb metastases.
- Participants must not have previously received neurotoxic chemotherapy for any reason (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib).
- Participants must not have pre-existing clinical peripheral neuropathy from any cause.
- Participants must not have a history of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, or peripheral arterial ischemia.
- Participants must not have any open skin wounds or ulcers of the limbs at the time of randomization.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Fairfield, Connecticut, United States
- New Haven, Connecticut, United States
- Trumbull, Connecticut, United States
- Atlanta, Georgia, United States
- Honolulu, Hawaii, United States
- Kansas City, Kansas, United States
- Overland Park, Kansas, United States
- Westwood, Kansas, United States
- Lexington, Kentucky, United States
- Clinton Township, Michigan, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- Lebanon, New Hampshire, United States
- Paramus, New Jersey, United States
- Ridgewood, New Jersey, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Gastonia, North Carolina, United States
- Greensboro, North Carolina, United States
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Fairfield, Connecticut, United States; New Haven, Connecticut, United States; Trumbull, Connecticut, United States; Atlanta, Georgia, United States; Honolulu, Hawaii, United States and 27 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.