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feasability and recruitment issues
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| Name | Class |
|---|---|
| Massage Therapy Foundation | OTHER |
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Feasibility study to examine the preventative ability of massage therapy on paclitaxel induced peripheral neuropathy in breast cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Massage Therapy | Experimental | Subjects who are planning treatment with paclitaxel as part of their standard of care treatment will receive a 20 minute massage prior to each paclitaxel infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Massage | Other | A 20 minute massage protocol will be administered in a chair by a licensed massage therapist no more than 24 hours prior to each paclitaxel infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment | rate of enrollment | 1 year |
| Feasibility of Retention | rate of drop out or consent withdraw | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of paclitaxel induced peripheral neuropathy | incidence of paclitaxel induced peripheral neuropathy as measured using the Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionaire | 10 months |
| Severity of paclitaxel induced peripheral neuropathy |
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Inclusion Criteria:
1) Breast cancer diagnosis 2) Planning to receive chemotherapy treatment with paclitaxel in the curative setting (adjuvant or neoadjuvant) on a weekly or bi-weekly schedule
Exclusion Criteria:
1)Diabetes or other neurological disorder 2) Current or previous peripheral neuropathy 3)Previous treatment with paclitaxel 4)Active deep vein thrombosis (DVT) within last 12 months or history of untreated lower extremity DVT
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| Name | Affiliation | Role |
|---|---|---|
| Bryan Schneider, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin & Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009443 | Neuritis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008405 | Massage |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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severity of paclitaxel induced peripheral neuropathy measured by Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionnaire |
| 10 months |
| Rate of pharmacological interventions | pharmacological interventions for paclitaxel induced peripheral neuropathy | 10 months |
| Paclitaxel dose modification | rate of dose modifications to paclitaxel treatment | 4 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |