Clinical trial NCT01819233: Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy
Official title: A Feasibility Pilot Trial Evaluating Caloric Restriction for Oncology Research in Early Stage Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of Participants Who Are Adherent to the Diet Restriction
timeFrame: Up to week 12
Secondary outcomes:
measure: Change in Body Fat Measurement
timeFrame: Baseline to 4 weeks after completion of study
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline to 4 weeks after completion of study
measure: Change in Heart Rate Over Time
timeFrame: Baseline to 4 weeks after completion of study
measure: Patterns of Change Over Time in Serum Markers
timeFrame: Baseline to 4 weeks after completion of study
measure: Patterns of Change Over Time in Psycho-social Outcomes Measured Using the Functional Assessment of Cancer Therapy-Breast (FACT-B)
timeFrame: Baseline to 4 weeks after completion of study
measure: Local Recurrence
timeFrame: Up to 4 weeks after completion of study
measure: Distant Metastases
timeFrame: Up to 4 weeks after completion of study
measure: Progression Free Survival
timeFrame: Up to 4 weeks after completion of study
measure: Overall Survival
timeFrame: Up to 4 weeks after completion of study
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Nicole Simone, MD
role: PRINCIPAL_INVESTIGATOR
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