Stanford APBI Trial
Clinical Trial
Overview
Intraoperative Radiotherapy (IORT) is one of three approaches used for accelerated, partial breast irradiation at Stanford.
Accelerated, partial breast irradiation (APBI) is a potentially important new way to incorporate radiotherapy in the treatment of women with breast cancer.
Currently, women with breast cancer who undergo a lumpectomy typically have 6 1/2 weeks of radiation to the entire affected breast after surgery. Accelerated, partial breast irradiation (APBI) changes this approach in two ways. It shortens the treatment time from 6 1/2 weeks to between 1 to 5 days, and reduces the treatment area from the entire breast to the area of the breast immediately around the lumpectomy site. This is the part of the breast where most cancers are likely to recur.
In many ways APBI is to current whole breast radiotherapy what a lumpectomy is to a mastectomy. The goal is to use a less invasive more focused treatment without compromising survival.
APBI has been used in limited trials in several hundred patients over the last 10 years. These trials show that in properly selected breast cancer patients APBI worked just as well as whole breast radiotherapy. In the initial studies, investigators relied on the placement of many catheters in the breast tissue (interstial brachytherapy). Newer techniques will hopefully provide the same good results but will deliver the radiation in faster and/or more convenient ways. This could increase interest in APBI and allow additional clinical trials that test the safety and effectiveness of the newer approaches. These newer approaches could increase quality of life for many women with breast cancer.
Investigators at Stanford University Medical Center are currently offering an IRB approved clinical trial that uses three new approaches for APBI. These three approaches are:
Intraoperative Radiotherapy (IORT) - 1 day
Intracavitary Brachytherapy (MammoSite) - 5 days
3-D Conformal/External Beam Radiotherapy - 5 days
The Stanford trial is led by Dr. Frederick Dirbas, Assistant Professor of Surgery, and by Dr. Donald Goffinet, Professor of Radiation Oncology. For further information about the trial please contact Janelle Maxwell or Triona Dolphin at (650) 498-7740.
Weight Loss Diet Study: Low Carb vs Low Fat
The traditional weight loss diet recommended by health professionals has been a low-fat, high-carbohydrate, calorie restricted diet. This recommendation has been challenged by a number of alternative dietary strategies, particularly low-carbohydrate diets. In several recent weight loss studies insulin resistant adults had more success with low- vs. high-carbohydrate diets, in contrast to insulin sensitive adults who had either more success or comparable success with the low-fat diets. The investigators enrolled 61 people with a wide range of insulin sensitivity/resistance. After determining their insulin resistance status, the investigators will split them in the middle and randomly assign them to one of four groups for six months: (1) Low-Carbohydrate/Insulin Resistant (LC/IR); (2) Low-Carbohydrate/Insulin Sensitive (LC/IS); (3) Low-Fat/Insulin Resistant (LF/IR); and (4) Low-Fat/Insulin Sensitive (LF/IS) (15 people/group). After 6 months the participants will switch diet for the following 6 months, i.e. those randomized to the Low-Carbohydrate diet will switch to the Low-Fat diet and vice-versa. The primary outcome of this study is to determine whether weight loss success can be increased if one follows the dietary approach appropriately matched to their insulin resistance status. Secondary outcomes include fasting insulin, glucose, lipids, and fatty acid composition.
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Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- behavioral: Low-Carbohydrate Diet
- behavioral: Low-Fat Diet
Eligibility
Inclusion Criteria:
- Age: > or = 18 years of age
- Women: Pre-menopausal (self-report) and <50 years of age
- Men: <50 years of age
- Race/Ethnicity: All
- BMI (body mass index): 28-40 kg/m2 (need to lose >10% body weight to achieve healthy
BMI)
- Body weight stable for the last two months, and not actively on a weight loss plan
- No plans to move from the area over the next 14 months
- Available and able to participate in the evaluations and intervention for the study
period
- Willing to accept random assignment
- To enhance study generalizability, people on medications not noted below as specific
exclusions can participate if they have been stable on such medications for at least
three months
- Ability and willingness to give written informed consent
- No known active psychiatric illness
Exclusion Criteria:
- Pregnant, lactating, within 6 months post-partum, or planning to become pregnant in
the next 12 months; no menstruation for the previous 12 months
- Diabetes (type 1 and 2) or history of gestational diabetes or on hypoglycemic
medications for any other indication
- Prevalent diseases: Malabsorption, renal or liver disease, active neoplasms, recent
myocardial infarction, hypertension (except for those stable on hypertensive
medications) (<6 months) (patient self-report and, if available, review of labs from
primary care provider)
- Smokers (because of effect on weight and lipids)
- History of serious arrhythmias, or cerebrovascular disease
- Uncontrolled hyper- or hypothyroidism (TSH not within normal limits)
- Medications: Lipid lowering, diabetes medications, and those known to affect
weight/energy expenditure
- Excessive alcohol intake (self-reported, >3 drinks/day)
Ages Eligible for Study
18 Years - 50 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Antonella Dewell
6507368577
Not Recruiting
What's New
Stanford’s APBI trial has now been expanded to include women with ductal carcinoma in situ (DCIS). Please call 650-498-7740 for more information.