Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT01819233
Eligibility Criteria:
Inclusion Criteria:
1. Pathologically proven diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer
2. Ability to have breast conservation as determined by the judgment of the radiation oncologist, for which the radiation oncologist has determined that he or she will only treat the whole breast and not regional lymph nodes
3. The patient must be female
4. Age \>= 18
5. If multifocal breast cancer, then it must be able to be resected through a single lumpectomy incision
6. Appropriate stage for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup:
1. History/physical examination, including breast exam and documentation of weight and Karnofsky performance status of 80-100% for at least 60 days prior to study entry
2. Ipsilateral mammogram within 6 months prior to study entry
7. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry
8. Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
9. Patient must capable of and provide study specific informed consent prior to study entry
10. Body mass index (BMI) \>= 21
11. Weight \>= 100 lbs
12. No prior history of non-breast malignancies in the past 2 years unless it was a non-melanomatous skin lesion or carcinoma in situ of the cervix
13. Patient must not have any of the following severe, active co-morbidity, defined as follows:
1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
2. Transmural myocardial infarction within the last 6 months
3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
6. Acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) positive based upon current Centers for Disease and Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism
14. Patient must not have active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
15. No prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields
16. Patient may not have any active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator
1. Inflammatory bowel disease
2. Celiac disease
3. Chronic pancreatitis
4. Chronic diarrhea or vomiting
5. Active eating disorder
17. Creatinine \< 1.7
18. Not currently taking steroids
19. No currently active pituitary secreting tumors up to physician discretion
20. No history of or current active drug/alcohol dependence
21. No patients being decisionally impaired
Exclusion Criteria:
1. Patient is not a candidate for breast conservation
2. Patient is male
3. Age \< 18 years
4. Patient requires regional lymph node irradiation therapy
5. Patient has evidence of distant metastases
6. Karnofsky performance status less than 80% within 60 days prior to study
7. Ipsilateral mammogram done greater than 6 months prior to study
8. Women of childbearing potential with a positive serum beta human chorionic gonadotropin (hCG)
9. Patient has a history of dementia, psychosis or other disorder affecting their mental status to the point where they cannot consent or comply with study guidelines
10. BMI \< 21
11. Weight \< 100 lbs
12. Weight loss \>= 10% in the last 3 months (mos)
13. Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 2 years prior to registration
14. Two or more breast cancers not resectable through a single lumpectomy incision
15. Non-epithelial breast malignancies such as sarcoma or lymphoma
16. Prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields
17. Severe, active co-morbidity, defined as follows:
1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
2. Transmural myocardial infarction within the last 6 months
3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
6. Acquired immune deficiency syndrome (AIDS) or HIV positive based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism
18. Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
19. Active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator
1. Inflammatory bowel disease
2. Celiac disease
3. Chronic pancreatitis
4. Chronic diarrhea or vomiting
5. Active eating disorder
20. Creatinine \>= 1.7
21. Current use of steroids
22. Pituitary secreting tumors up to physician discretion
23. Active drug/alcohol dependence or abuse history
24. Decisionally impaired patients
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01819233
Study Brief:
Protocol Section:
NCT01819233