Ductal Breast Carcinoma in Situ, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma, Lobular Breast Carcinoma in Situ, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer
Conditions
Brief summary
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.
Detailed description
PRIMARY OBJECTIVE: 1. Investigate the feasibility of a clinical trial administering ionizing radiation with concurrent caloric restriction (CR) for the treatment of breast cancer. SECONDARY OBJECTIVE: 2. Investigate measurable changes of patient characteristics and tissue and serum from CR conditions to determine a metric for evaluating this treatment in future studies. OUTLINE: Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy once daily (QD) 5 days a week for 6 weeks.
Interventions
BEHAVIORALBehavioral dietary intervention
Receive caloric restricted dietary intervention
PROCEDURETherapeutic conventional surgery
Undergo definitive lumpectomy
RADIATIONRadiation therapy
Undergo radiation therapy
OTHERCounseling intervention
Receive dietary counseling
PROCEDUREQuality-of-life assessment
Ancillary studies
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Are Adherent to the Diet Restriction | Up to week 12 | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | Baseline to 4 weeks after completion of study | Assessed via mixed-effects regression. Weight changes over time assessed by modeling BMI as a function of time |
| Change in Heart Rate Over Time | Baseline to 4 weeks after completion of study | Assessed via mixed-effects regression. |
| Patterns of Change Over Time in Serum Markers | Baseline to 4 weeks after completion of study | Assessed via mixed-effects regression. |
| Patterns of Change Over Time in Psycho-social Outcomes Measured Using the Functional Assessment of Cancer Therapy-Breast (FACT-B) | Baseline to 4 weeks after completion of study | 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) |
| Change in Body Fat Measurement | Baseline to 4 weeks after completion of study | Analyzed via a paired t-test. Change in body fat measurement as determined by the Durnin-Womersley 4-fold technique |
| Distant Metastases | Up to 4 weeks after completion of study | Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test. |
| Progression Free Survival | Up to 4 weeks after completion of study | Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test. |
| Overall Survival | Up to 4 weeks after completion of study | Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test. |
| Local Recurrence | Up to 4 weeks after completion of study | Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Dietary Intervention Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
Behavioral dietary intervention: Receive caloric restricted dietary intervention
Therapeutic conventional surgery: Undergo definitive lumpectomy
Radiation therapy: Undergo radiation therapy
Counseling intervention: Receive dietary counseling
Quality-of-life assessment: Ancillary studies | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Behavioral Dietary Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 14 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
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%.
Time frame: Up to week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Behavioral Dietary Intervention | Number of Participants Who Are Adherent to the Diet Restriction | 28 participants |
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
Time frame: Baseline to 4 weeks after completion of study
Population: patients who did not complete all assessments were not included in the analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Behavioral Dietary Intervention | Change in Body Fat Measurement | -3.1 percentage of change in body fat |
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
Time frame: Baseline to 4 weeks after completion of study
Population: participants who did not complete all timepoint measurements were not included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Behavioral Dietary Intervention | Change in Body Mass Index (BMI) | -1.2 percentage of change in BMI |
Secondary
Change in Heart Rate Over Time
Assessed via mixed-effects regression.
Time frame: Baseline to 4 weeks after completion of study
Population: only participants who completed all timepoints were included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Dietary Intervention | Change in Heart Rate Over Time | 67.3 beats per minute | Standard Error 1.5 |
Secondary
Distant Metastases
Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Time frame: Up to 4 weeks after completion of study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Dietary Intervention | Distant Metastases | NA Participants |
Secondary
Local Recurrence
Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Time frame: Up to 4 weeks after completion of study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Dietary Intervention | Local Recurrence | NA Participants |
Secondary
Overall Survival
Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Time frame: Up to 4 weeks after completion of study
Population: Insufficient data was collected to conduct survival analysis as there were participants who were lost to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Dietary Intervention | Overall Survival | NA Participants |
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)
Time frame: Baseline to 4 weeks after completion of study
Population: patients who did not complete all questionnaire timepoints were not included in the analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Behavioral Dietary Intervention | Patterns of Change Over Time in Psycho-social Outcomes Measured Using the Functional Assessment of Cancer Therapy-Breast (FACT-B) | 0.8 score on a scale |
Secondary
Patterns of Change Over Time in Serum Markers
Assessed via mixed-effects regression.
Time frame: Baseline to 4 weeks after completion of study
Secondary
Progression Free Survival
Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Time frame: Up to 4 weeks after completion of study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Dietary Intervention | Progression Free Survival | NA Participants |