Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection
Trial Sites
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Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Supportive care | Active | 18 and over | NCI, Other | CDR0000494652 CALGB-70305, NCT00376597 |
Summary
RATIONALE: A personalized exercise program, counseling, and education materials may be more effective than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection.
PURPOSE: This randomized clinical trial is studying how well education with or without exercise and counseling works in preventing lymphedema in women with stage I, stage II, or stage III breast cancer who are undergoing axillary lymph node dissection.
Further Study Information
OBJECTIVES:
Primary
- Determine the efficacy of a comprehensive program of tailored exercise, lymphedema prevention patient education, and counseling vs lymphedema prevention patient education only in reducing the incidence of lymphedema in women with stage I-III breast cancer who are undergoing axillary lymph node dissection.
Secondary
- Compare the severity of lymphedema, in terms of changes in arm circumference at the site of greatest difference as a continuous variable, in patients undergoing these interventions.
- Assess the agreement between patients' self-report of swelling (mild, moderate, or severe) and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference (< 0.5 inches vs ≥ 0.5 and < 2 inches vs ≥ 2 inches).
- Compare the health-related quality of life of these patients.
- Characterize adherence to lymphedema prevention exercises, lymphedema knowledge, and range of motion.
OUTLINE: This is a randomized, controlled, multicenter study where the unit of randomization is the participating center. Participating centers are stratified according to the annual number of patients with stage I-III breast cancer who undergo axillary node dissection at the center (small vs moderate vs large number of patients) and are randomized to 1 of 2 arms. Patients are thus randomized to 1 of 2 intervention arms based on the identified participating center.
All patients complete questionnaires prior to surgery regarding lymphedema knowledge, health-related quality of life, fear of cancer recurrence, self-efficacy, body-image, self-report of range of motion, arm circumference, and demographics. Patients then undergo surgery, which must include axillary node dissection.
- Arm I: Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
- Arm II: Patients receive lymphedema education and complete physical assessments and questionnaires as in arm I. Patients also complete a personalized exercise regimen, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Newly diagnosed disease
- Stage I-III disease
- No diagnosed lymphedema
- Must have arm measurements for axilla, elbow, and wrist that fall within the ranges for one of six sleeve sizes (i.e., all three measurments must be found in one column) available
- Scheduled to undergo axillary node dissection with ≥ 10 nodes removed
- No sentinel axillary node dissection only
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- No documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease that, in the opinion of the investigator, significantly increases mortality over the next 2 years
- May not be currently homebound or dependent upon a walker or wheelchair for mobility
- Able to participate in a mild exercise program
- No prior history of carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or invasive breast cancer
- Patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis
- Patients with basal cell and squamous cell carcinoma of the skin are eligible
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior double mastectomy, axillary node dissection, and/or radiotherapy involving both arms
- Prior treatment (i.e., surgergy and/or radiotherapy) on the contralateral arm allowed provided it is documented appropriately
- May be enrolled on other treatment trials except surgery trials where one treatment arm involves full axillary node dissection
- Patients enrolled on ACOSOG-Z1071 allowed
- Any type of radiotherapy to the breast or axilla allowed
- Neoadjuvant treatment for this cancer allowed
Trial Lead Organizations/Sponsors
Cancer and Leukemia Group B
National Cancer Institute| Electra D. Paskett |  | Study Chair |
Trial Sites
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| U.S.A. | |||
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| California | |||
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| Castro Valley | |||
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| East Bay Radiation Oncology Center | |||
| James H. Feusner | Ph: 510-450-7600 | ||
| Valley Medical Oncology Consultants - Castro Valley | |||
| James H. Feusner | Ph: 510-450-7600 | ||
| Concord | |||
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| Cancer Care Center at John Muir Health - Concord Campus | |||
| Deborah L. Kerlin | Ph: 925-674-2580 | ||
| Fremont | |||
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| Valley Medical Oncology | |||
| James H. Feusner | Ph: 510-450-7600 | ||
| Martinez | |||
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| Contra Costa Regional Medical Center | |||
| James H. Feusner | Ph: 510-450-7600 | ||
| Mountain View | |||
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| El Camino Hospital Cancer Center | |||
| James H. Feusner | Ph: 510-450-7600 | ||
| Oakland | |||
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| Alta Bates Summit Medical Center - Summit Campus | |||
| James H. Feusner | Ph: 510-450-7600 | ||
| Bay Area Breast Surgeons, Incorporated | |||
| James H. Feusner | Ph: 510-450-7600 | ||
| CCOP - Bay Area Tumor Institute | |||
| James H. Feusner | Ph: 510-450-7600 | ||
| Highland General Hospital | |||
| James H. Feusner | Ph: 510-450-7600 | ||
| Larry G Strieff MD Medical Corporation | |||
| James H. Feusner | Ph: 510-450-7600 | ||
| Tom K Lee, Incorporated | |||
| James H. Feusner | Ph: 510-450-7600 | ||
| San Pablo | |||
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| Doctors Medical Center - San Pablo Campus | |||
| James H. Feusner | Ph: 510-450-7600 | ||
| Walnut Creek | |||
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| John Muir/Mt. Diablo Comprehensive Cancer Center | |||
| Deborah L. Kerlin | Ph: 925-674-2580 | ||
| Connecticut | |||
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| Bridgeport | |||
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| St. Vincent's Medical Center | |||
| Anthy Demestihas | Ph: 888-823-5923 | ||
| Email: ctsucontact@westat.com | |||
| Delaware | |||
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| Lewes | |||
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| Tunnell Cancer Center at Beebe Medical Center | |||
| Stephen Scott Grubbs | Ph: 302-733-6227 | ||
| Newark | |||
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| Helen F. Graham Cancer Center at Christiana Hospital | |||
| Stephen Scott Grubbs | Ph: 302-733-6227 | ||
| District of Columbia | |||
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| Washington | |||
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| Kaiser Permanente at Capitol Hill Medical Center | |||
| Amadea Tette | Ph: 888-823-5923 | ||
| Email: ctsucontact@westat.com | |||
| Florida | |||
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| Deerfield Beach | |||
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| North Broward Medical Center | |||
| Douglas E Faig | Ph: 954-941-8300 | ||
| Jupiter | |||
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| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | |||
| Michael Schwartz | Ph: 305-674-2625 | ||
| Email: info@msccop.com | |||
| Miami Beach | |||
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| CCOP - Mount Sinai Medical Center | |||
| Michael Schwartz | Ph: 305-674-2625 | ||
| Email: info@msccop.com | |||
| Pensacola | |||
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| Sacred Heart Cancer Center at Sacred Heart Hospital | |||
| Thomas D. Sunnenberg | Ph: 850-416-4611 | ||
| Tallahassee | |||
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| Tallahassee Memorial Hospital | |||
| Shelby L Blank | Ph: 850-431-5566 | ||
| Email: Theresa.Shannon@tmh.org | |||
| Illinois | |||
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| Chicago | |||
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| Resurrection Medical Center | |||
| Lisa L Baddi | Ph: 773-792-5116 | ||
| University of Chicago Cancer Research Center | |||
| Gini F. Fleming | Ph: 773-834-7424 | ||
| Elk Grove Village | |||
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| Cancer Institute at Alexian Brothers | |||
| Alkarim Tajuddin | Ph: 847-952-7164 | ||
| Email: fredianc@alexian.net | |||
| Harvey | |||
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| Ingalls Cancer Care Center at Ingalls Memorial Hospital | |||
| Mark F. Kozloff | Ph: 708-915-4673 | ||
| Email: clinicaltrials@ingalls.org | |||
| Moline | |||
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| Garneau, Stewart C MD (UIA Investigator) | |||
| Costas L. Constantinou | Ph: 319-363-2690 | ||
| Porubcin, Michael MD (UIA Investigator) | |||
| Costas L. Constantinou | Ph: 319-363-2690 | ||
| Spector, David MD (UIA Investigator) | |||
| Costas L. Constantinou | Ph: 319-363-2690 | ||
| Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | |||
| Costas L. Constantinou | Ph: 319-363-2690 | ||
| Indiana | |||
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| La Porte | |||
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| Center for Cancer Therapy at LaPorte Hospital and Health Services | |||
| Rafat H. Ansari | Ph: 574-234-5123 | ||
| Mishawaka | |||
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| Saint Joseph's Medical Center | |||
| Rafat H. Ansari | Ph: 574-234-5123 | ||
| South Bend | |||
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| CCOP - Northern Indiana CR Consortium | |||
| Rafat H. Ansari | Ph: 574-234-5123 | ||
| Memorial Hospital of South Bend | |||
| Rafat H. Ansari | Ph: 574-234-5123 | ||
| Michiana Hematology-Oncology, PC - South Bend | |||
| Rafat H. Ansari | Ph: 574-234-5123 | ||
| Iowa | |||
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| Bettendorf | |||
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| Constantinou, Costas L MD (UIA Investigator) | |||
| Costas L. Constantinou | Ph: 319-363-2690 | ||
| Kansas | |||
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| Chanute | |||
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| Cancer Center of Kansas, PA - Chanute | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Dodge City | |||
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| Cancer Center of Kansas, PA - Dodge City | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| El Dorado | |||
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| Cancer Center of Kansas, PA - El Dorado | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Fort Scott | |||
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| Cancer Center of Kansas - Fort Scott | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Independence | |||
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| Cancer Center of Kansas-Independence | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Kingman | |||
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| Cancer Center of Kansas, PA - Kingman | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Lawrence | |||
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| Lawrence Memorial Hospital | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Liberal | |||
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| Cancer Center of Kansas, PA - Liberal | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| McPherson | |||
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| Cancer Center of Kansas, PA - McPherson | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Newton | |||
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| Cancer Center of Kansas, PA - Newton | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Parsons | |||
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| Cancer Center of Kansas, PA - Parsons | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Pratt | |||
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| Cancer Center of Kansas, PA - Pratt | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Salina | |||
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| Cancer Center of Kansas, PA - Salina | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Wellington | |||
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| Cancer Center of Kansas, PA - Wellington | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Wichita | |||
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| Associates in Women's Health, PA - North Hillside | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Cancer Center of Kansas, PA - Medical Arts Tower | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Cancer Center of Kansas, PA - Wichita | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| CCOP - Wichita | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Via Christi Cancer Center at Via Christi Regional Medical Center | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Winfield | |||
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| Cancer Center of Kansas, PA - Winfield | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Kentucky | |||
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| Lexington | |||
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| Central Baptist Hospital | |||
| Peter S. Tate | Ph: 859-260-6425 | ||
| Maine | |||
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| York | |||
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| York Hospital's Oncology Treatment Center | |||
| Jonathan D Eneman | Ph: 207-351-3777 | ||
| Maryland | |||
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| Baltimore | |||
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| Kaiser Permanente at Woodlawn Medical Center | |||
| Amadea Tette | Ph: 888-823-5923 | ||
| Email: ctsucontact@westat.com | |||
| Elkton MD | |||
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| Union Hospital of Cecil County | |||
| Stephen Scott Grubbs | Ph: 302-733-6227 | ||
| Gaithersburg | |||
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| Kaiser Permanente - Gaithersburg Medical Center | |||
| Amadea Tette | Ph: 888-823-5923 | ||
| Email: ctsucontact@westat.com | |||
| Largo | |||
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| Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility | |||
| Amadea Tette | Ph: 888-823-5923 | ||
| Email: ctsucontact@westat.com | |||
| Silver Spring | |||
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| Holy Cross Hospital | |||
| Cheryl A. Aylesworth | Ph: 301-896-2719 | ||
| Email: Bsquiller@suburbanhospital.org | |||
| Massachusetts | |||
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| Boston | |||
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| Tufts Medical Center Cancer Center | |||
| Janice G Rothschild | Ph: 617-636-5000 | ||
| Email: ContactUsCancerCenter@TuftsMedicalCenter.org | |||
| Hyannis | |||
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| Davenport-Mugar Cancer Center at Cape Cod Hospital | |||
| Frank G Basile | Ph: 508-862-5799 | ||
| Michigan | |||
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| Battle Creek | |||
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| Battle Creek Health System Cancer Care Center | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Big Rapids | |||
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| Mecosta County Medical Center | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Grand Rapids | |||
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| Butterworth Hospital at Spectrum Health | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| CCOP - Grand Rapids | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Lacks Cancer Center at Saint Mary's Health Care | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Muskegon | |||
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| Mercy General Health Partners | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Traverse City | |||
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| Munson Medical Center | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| New Jersey | |||
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| Camden | |||
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| Cancer Institute of New Jersey at Cooper University Hospital - Camden | |||
| Stephen Scott Grubbs | Ph: 302-733-6227 | ||
| Elizabeth | |||
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| Trinitas Comprehensive Cancer Center at Trinitas Hospital | |||
| Clarissa F Henson | Ph: 908-994-8000 | ||
| North Carolina | |||
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| Goldsboro | |||
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| Wayne Memorial Hospital, Incorporated | |||
| James N. Atkins | Ph: 919-580-0000 | ||
| Greenville | |||
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| Leo W. Jenkins Cancer Center at ECU Medical School | |||
| Rachel E Raab | Ph: 252-744-2161 | ||
| North Dakota | |||
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| Fargo | |||
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| Roger Maris Cancer Center at MeritCare Hospital | |||
| Preston D. Steen | Ph: 701-234-6161 | ||
| Ohio | |||
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| Columbus | |||
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| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | |||
| Lisa D Yee | Ph: 866-627-7616 | ||
| Email: osu@emergingmed.com | |||
| Pennsylvania | |||
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| Dubois | |||
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| Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center | |||
| Carmine Marchioli | Ph: 570-342-3675ext218 | ||
| Tennessee | |||
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| Cookeville | |||
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| Cookeville Regional Medical Center | |||
| Venumadhav R Kotla | Ph: 931-783-2714 | ||
| Texas | |||
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| Houston | |||
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| M. D. Anderson Cancer Center at University of Texas | |||
| Jamie L Wagner | |||
| Email: jwagner@mdanderson.org | |||
| Univeristy of Texas M.D. Anderson Cancer Center | |||
| Jamie L Wagner | Ph: 713-792-3245 | ||
| Laredo | |||
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| Doctor's Hospital of Laredo | |||
| Gary W. Unzeitig | Ph: 888-823-5923 | ||
| Email: ctsucontact@westat.com | |||
| Virginia | |||
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| McLean | |||
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| Kaiser Permanente Tysons Corner Medical Center | |||
| Amadea Tette | Ph: 888-823-5923 | ||
| Email: ctsucontact@westat.com | |||
| West Virginia | |||
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| Huntington | |||
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| St. Mary's Regional Cancer Center at St. Mary's Medical Center | |||
| James H Morgan | |||
| Email: calgbco@calgb.org | |||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00376597
Information obtained from ClinicalTrials.gov on April 04, 2013
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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