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| ID | Type | Description | Link |
|---|---|---|---|
| JT 2312 | Other Identifier | JeffTrial Number |
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NAC is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement and also is available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. In the exercise physiology literature, both oral and injectable NAC have been shown to reduce fatigue and improve recovery from exertion which has interesting implications for exploring cancer-related fatigue.
In terms of cancer cell biology, reactive oxygen species (ROS) may play an important role in the development and progression of breast cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV and oral n-acetylcysteine | Experimental | 50-150mg/kg of n-acetylcysteine intravenously once a week for at least two weeks. 600mg n-acetylcysteine orally twice daily except on day of infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV/oral n-acetylcysteine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | To assess the feasibility of evaluating the effect of n-acetylcysteine on tumor cell metabolism by assessing the changes in expression of caveolin -1 and MCT4 in cancer associated fibroblasts in pre and post therapy breast tissue treated with NAC. | 2-4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | To confirm the safety of combined oral and IV NAC in patients with breast cancer. This will be evaluated by the number of participants with adeverse events and Grade 3/4 toxicities according to CTCAE v3.0 | 2-4 weeks |
| 2. To access the changes in HIF-1 alpha and p65 subunit of NFB in tumor stroma in pre and post therapy breast tissue treated with NAC |
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Inclusion Criteria:
Disease related
Laboratory
General
Exclusion Criteria:
Disease Related
Curatively treated cervical carcinoma in situ, or
Curatively resected non-melanomatous skin cancer, or
Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≤ 3 years prior to enrollment
Medications/Treatments
General
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Monti, MD, MBA | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Myrna Brind Center for Integrative Medicine | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Thomas Jefferson University Hospital | View source |
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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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To access the changes in HIF-1 alpha and p65 subunit of NFB in tumor stroma in pre and post therapy breast tissue treated with NAC |
| 2-4 weeks |
| To evaluate potential effects of NAC on quality of life and fatigue | To evaluate potential effects of NAC on quality of life and fatigue using the FACT-G, Brief Fatigue Inventory, and PROMIS quality assessment instruments. | 2-4 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |