Recurrent Breast Cancer Clinical Trial
— CAREFOROfficial title:
A Feasibility Pilot Trial Evaluating Caloric Restriction for Oncology Research in Early Stage Breast Cancer Patients
Verified date | February 2024 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot clinical trial studies caloric restriction in patients with stage 0-I breast cancer during surgery and radiation therapy. Reducing caloric intake may prevent disease progression in patients with breast cancer. Radiation therapy uses high energy x rays to kill tumor cells. Giving dietary intervention and radiation therapy together may kill more tumor cells.
Status | Completed |
Enrollment | 38 |
Est. completion date | September 2019 |
Est. primary completion date | September 14, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Cancer Center at Thomas Jefferson University |
United States,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Are Adherent to the Diet Restriction | Computed along with a 95% exact confidence interval. Exact binomial test (with a one-sided alpha of 0.05) will be used to test whether adherence is greater than 60%. | Up to week 12 | |
Secondary | Change in Body Fat Measurement | Analyzed via a paired t-test. Change in body fat measurement as determined by the Durnin-Womersley 4-fold technique | Baseline to 4 weeks after completion of study | |
Secondary | Change in Body Mass Index (BMI) | Assessed via mixed-effects regression. Weight changes over time assessed by modeling BMI as a function of time | Baseline to 4 weeks after completion of study | |
Secondary | Change in Heart Rate Over Time | Assessed via mixed-effects regression. | Baseline to 4 weeks after completion of study | |
Secondary | Patterns of Change Over Time in Serum Markers | Assessed via mixed-effects regression. | Baseline to 4 weeks after completion of study | |
Secondary | Patterns of Change Over Time in Psycho-social Outcomes Measured Using the Functional Assessment of Cancer Therapy-Breast (FACT-B) | Assessed via mixed-effects regression. The FACT-B is a questionnaire using a 5-point Likert scale (0-Not at all to 4-Very much) | Baseline to 4 weeks after completion of study | |
Secondary | Local Recurrence | Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test. | Up to 4 weeks after completion of study | |
Secondary | Distant Metastases | Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test. | Up to 4 weeks after completion of study | |
Secondary | Progression Free Survival | Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test. | Up to 4 weeks after completion of study | |
Secondary | Overall Survival | Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test. | Up to 4 weeks after completion of study |
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