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| ID | Type | Description | Link |
|---|---|---|---|
| PNCC-03312-05-C | |||
| UMN-0508M72428 |
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unable to accrue study participants
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RATIONALE: L-carnitine L-tartrate may prevent peripheral neuropathy caused by chemotherapy.
PURPOSE: This randomized clinical trial is studying how well L-carnitine L-tartrate works in preventing peripheral neuropathy caused by chemotherapy in women with metastatic breast cancer.
OBJECTIVES:
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Patients complete questionnaires periodically to assess neuropathy, pain, fatigue, sleep, and activities of daily living.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. |
|
| Arm II | Placebo Comparator | Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-carnitine L-tartrate | Drug | Given orally |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork | Data was not analyzed due to study termination | baseline, days 1 and 2 post chemo x 4 cycles |
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DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
Scheduled to receive ≥ 1 of the following chemotherapy drugs:
Paclitaxel
Docetaxel
Capecitabine
Gemcitabine hydrochloride
Albumin-bound paclitaxel (Abraxane)
Doxorubicin hydrochloride
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Alice Shapiro, PhD | Park Nicollet Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| Park Nicollet Cancer Center |
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oncology clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I | Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. L-carnitine L-tartrate: Given orally |
| FG001 | Arm II |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Other |
Given orally |
|
| Saint Louis Park |
| Minnesota |
| 55426 |
| United States |
Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. placebo: Given orally |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I | Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. L-carnitine L-tartrate: Given orally |
| BG001 | Arm II | Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. placebo: Given orally |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | data was not analyzed due to study termination | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork | Data was not analyzed due to study termination | Posted | baseline, days 1 and 2 post chemo x 4 cycles |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I L-Carnitine | Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. L-carnitine L-tartrate: Given orally | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | Arm II-Placebo | Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. placebo: Given orally | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alice Shapiro | HealthPartnersInstitute | 952-993-1704 | shapia@parknicollet.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Between 18 and 65 years |
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| >=65 years |
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