Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer (NAC)
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|ClinicalTrials.gov Identifier: NCT01878695|
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : June 20, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Stage 0/1 Breast Cancer Post Biopsy Pre-surgery||Drug: IV/oral n-acetylcysteine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer|
|Actual Study Start Date :||July 26, 2012|
|Actual Primary Completion Date :||May 14, 2015|
|Actual Study Completion Date :||May 14, 2015|
Experimental: IV and oral n-acetylcysteine
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
Drug: IV/oral n-acetylcysteine
- Efficacy [ Time Frame: 2-4 weeks ]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.
- Safety [ Time Frame: 2-4 weeks ]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. 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 [ Time Frame: 2-4 weeks ]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
- To evaluate potential effects of NAC on quality of life and fatigue [ Time Frame: 2-4 weeks ]To evaluate potential effects of NAC on quality of life and fatigue using the FACT-G, Brief Fatigue Inventory, and PROMIS quality assessment instruments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878695
|United States, Pennsylvania|
|Jefferson Myrna Brind Center for Integrative Medicine|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Daniel Monti, MD, MBA||Sidney Kimmel Cancer Center at Thomas Jefferson University|