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To investigate if topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel (AKL in PLO gel) can improve management of neuropathic pain from radiation skin reactions adjunctively or better than standard treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel(AKL in PLO gel) | Drug | Subjects will be taught to apply topical 2%amitriptyline, 1% ketamine and 5% lidocaine(AKL) in PLO gel to the sites of maximum neuropathic pain three times per day for up to 2 weeks after completion of radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure will to use the validated University of Washington Neuropathic Pain Scale (UWNPS) on all radiation skin reaction subjects requiring standard intervention. | University of Washington Neuropathic Pain scale will be conducted at the time of assessment, every 2-5 days while on radiotherapy, week 2 and 6 weeks post radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Toxicity Assessment Tool (STAT) | Presence of dry desquamation or worse on STAT at baseline assessment, complete STAT 30 minutes post application of cream, every 2-5 days while on radiotherapy, week 2 and 6 weeks after completing radiation therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabella Uzaraga, MD | BC Cancer Agency - Vancouver Island Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer Agency Vancouver Island BCCA | Victoria | British Columbia | V8R 6V5 | Canada |
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| ID | Term |
|---|---|
| D000639 | Amitriptyline |
| D007649 | Ketamine |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |