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| Name | Class |
|---|---|
| Terry Fox Foundation | OTHER |
| Duke-NUS Academic Medicine Research Institute | UNKNOWN |
| Singapore General Hospital | OTHER |
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The trial will be preceded by a pilot phase study in 5 patients.
This will then be followed by the randomized 1:1 phase II trial testing the utility of regional cryotherapy in preventing or reducing paclitaxel-induced peripheral neuropathy compared to no treatment.
It is hypothesized that cryotherapy causes regional blood vessel constriction and decreases the paclitaxel exposure to the distal epithelial nerve fibres, thus resulting in decreased nerve damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel and Elasto-Gelâ„¢ Cryotherapy | Experimental | Cryotherapy will be applied using Elasto-Gelâ„¢ hypothermia mitts and slippers for 15 minutes before, during and 15 minutes after each paclitaxel infusion. |
|
| Paclitaxel alone | Other | Paclitaxel will be administered without cryotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elasto-Gelâ„¢ | Device | Elasto-Gelâ„¢ hypothermia mitts and slippers contain glycerine, which has thermal properties, allowing use for cold therapies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients reporting level C and above subjective symptoms, in cryotherapy arm versus controlled arm, based on the Patient Neurotoxicity Questionnaire (PNQ) at 3 months after baseline | PNQ scale ranges from scores A to E; with scoring of A being not affected neuropathy, and E with the worst neuropathy | From commencement to completion of 12 paclitaxel infusions - estimated 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients reporting level C and above subjective symptoms, in cryotherapy arm versus controlled arm, based on the Patient Neurotoxicity Questionnaire (PNQ) at 15 months after baseline | From commencement to completion of primary chemotherapy - estimated 15 months | |
| Proportion of patients with lower sensory velocity and amplitudes (based on nerve conduction tests), in cryotherapy arm versus controlled arm, at 15 months after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Kiley Loh Wei-Jen, MD | Contact | +65 6436 8000 | kiley.loh.w.j@singhealth.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Dr Kiley Loh Wei-Jen, MD | National Cancer Centre, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Centre Singapore | Recruiting | Singapore | 169610 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33424755 | Derived | Ng DQ, Tan CJ, Soh BC, Tan MML, Loh SY, Tan YE, Ong HH, Teng PPC, Chan JJ, Chay WY, Lee J, Lai G, Beh SY, Tan TJY, Yap YS, Lee GE, Wong M, Dent R, Lo YL, Chan A, Loh KW. Impact of Cryotherapy on Sensory, Motor, and Autonomic Neuropathy in Breast Cancer Patients Receiving Paclitaxel: A Randomized, Controlled Trial. Front Neurol. 2020 Dec 18;11:604688. doi: 10.3389/fneur.2020.604688. eCollection 2020. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel | Drug | 80mg/m^2 of Paclitaxel is administered by infusion for 60 mins once a week, for a total of 12 cycles |
|
| From commencement to completion of primary chemotherapy - estimated 15 months |
| Incidence of adverse events, in cryotherapy arm versus controlled arm | From commencement to completion of 12 paclitaxel infusions - estimated 3 months |
| Proportion of patients reported intolerance and require cessation of therapies, in cryotherapy arm versus controlled arm | From commencement to completion of 12 paclitaxel infusions - estimated 3 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |