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Nanoparticle albumin-bound paclitaxel has greater efficacy and favorable safety profile than standard paclitaxel. However, rate of neuropathy caused by nanoparticle albumin-bound paclitaxel is higher than standard paclitaxel, and is one of its dose-limited toxicities. Previously, compression therapy by surgical gloves has shown effectiveness in preventing chemotherapy-induced neuropathy. We designed this multi-center prospective self-control phase III study to investigate the efficacy of compression gloves to reduce albumin-binding paclitaxel induced sensory and motor neurotoxicity of upper extremities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Other | Patients diagnosed with solid tumors who are about to received albumin-binding paclitaxel monotherapy are recruited. Dominant hands and non-dominant hands are treated with small-size compression gloves and suitable-size compression gloves, respectively, during the administration of albumin-binding paclitaxel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compression gloves | Device | Patients wear small-size compression gloves (one or two size smaller than suitable size) for dominant hands and suitable-size compression gloves for non-dominant hands for 90 minutes during the administration of albumin-binding paclitaxel (start from 30 minutes before albumin-binding paclitaxel infusion). |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in severe peripheral sensory neurotoxicity rates | Differences in peripheral sensory neurotoxicity (NCI-CTCAE Grade 2-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy. | 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in total peripheral sensory neurotoxicity rates | Differences in total peripheral sensory neurotoxicity (NCI-CTCAE Grade 1-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy. | 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days). |
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Inclusion Criteria:
Patients are diagnosed with pathologically confirmed solid tumors.
Patients are about to receive albumin-binding paclitaxel monotherapy (at least 4 cycles anticipated) by physicians' choice.
Patients should have baseline Grade 0 peripheral sensory and motor neurotoxicity (NCI-CTCAE 5.0).
Eastern Cooperative Oncology Group performance status ≤ 1.
Biochemical tests within 7 days before inclusion should meet the following criteria:
Life expectancy ≥ 12 weeks.
No history of severe diseases in important organs including heart, lung, liver, and kidney.
Willingness to sign a written informed consent.
Willingness to adhere to dose and visit schedules.
Women of child-bearing ages should be willing to take birth control methods during treatment and within 8 weeks after trial, and pregnancy test (blood or urine) within 14 days before inclusion should be negative (if positive, ultrasound should be performed to rule out pregnancy). Male patients should be willing to take birth control methods during treatment and within 8 weeks after trial or be sterilized by surgery .
Exclusion Criteria:
Elimination Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhang, PhD | Contact | 86-21-64175590 | syner2000@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Zhang, PhD | Department of medical oncology, Fudan University Shanghai Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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|
| Differences in severe peripheral motor neurotoxicity rates | Differences in severe peripheral motor neurotoxicity (NCI-CTCAE Grade 2-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy. | 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days). |
| Differences in total peripheral motor neurotoxicity rates | Differences in total peripheral motor neurotoxicity (NCI-CTCAE Grade 1-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy. | 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days). |
| Differences in peripheral neurotoxicity questionaire scores | Differences in peripheral neurotoxicity questionaire scores between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy. | 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days). |
| Safety of compression gloves in preventing albumin-binding paclitaxel induced neurotoxicity. | Adverse events related to compression gloves intervention are collected. | From date of consent to one months after Cycle 4 administration of albumin-binding paclitaxel (each cycle is 21 days). |