Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy

Not Applicable

Completed

Conditions: Recurrent Breast Cancer
Ductal Breast Carcinoma in Situ
Invasive Lobular Breast Carcinoma
Lobular Breast Carcinoma in Situ
Invasive Ductal Breast Carcinoma
Stage IB Breast Cancer
Stage IA Breast Cancer

Interventions: Behavioral: Behavioral dietary intervention
Procedure: Therapeutic conventional surgery
Radiation: Radiation therapy
Other: Counseling intervention
Procedure: Quality-of-life assessment

Registration Number: NCT01819233

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 38

Inclusion Criteria

Pathologically proven diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer
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
The patient must be female
Age >= 18
If multifocal breast cancer, then it must be able to be resected through a single lumpectomy incision
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
Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry
Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
Patient must capable of and provide study specific informed consent prior to study entry
Body mass index (BMI) >= 21
Weight >= 100 lbs
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
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
Patient must not have active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
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
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
Creatinine < 1.7
Not currently taking steroids
No currently active pituitary secreting tumors up to physician discretion
No history of or current active drug/alcohol dependence
No patients being decisionally impaired

Exclusion Criteria

Patient is not a candidate for breast conservation
Patient is male
Age < 18 years
Patient requires regional lymph node irradiation therapy
Patient has evidence of distant metastases
Karnofsky performance status less than 80% within 60 days prior to study
Ipsilateral mammogram done greater than 6 months prior to study
Women of childbearing potential with a positive serum beta human chorionic gonadotropin (hCG)
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
BMI < 21
Weight < 100 lbs
Weight loss >= 10% in the last 3 months (mos)
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
Two or more breast cancers not resectable through a single lumpectomy incision
Non-epithelial breast malignancies such as sarcoma or lymphoma
Prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields
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
Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
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
Creatinine >= 1.7
Current use of steroids
Pituitary secreting tumors up to physician discretion
Active drug/alcohol dependence or abuse history
Decisionally impaired patients

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral dietary intervention	Radiation therapy	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	Quality-of-life assessment	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	Therapeutic conventional surgery	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	Counseling 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	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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 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)
Local Recurrence	Up to 4 weeks after completion of study	Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Distant Metastases	Up to 4 weeks after completion of study	Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.
Patterns of Change Over Time in Serum Markers	Baseline to 4 weeks after completion of study	Assessed via mixed-effects regression.