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Caloric Restriction + Stereotactic Body Radiation Therapy for Breast Cancer
Study Summary
This trial is studying the effect of calorie reduction on patients with breast cancer undergoing stereotactic ablative radiation therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 29 Patients • NCT02045446Trial Design
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Who is running the clinical trial?
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- My tumor, including all areas, is 3 cm or smaller.You have a serious mental health condition that might make it hard for you to follow the study's plan, according to your doctor.I have a few cancer spread sites and my doctor is treating me to cure.I have suspicious lymph nodes near my collarbone or breastbone not proven negative by biopsy.I am not being considered for chemotherapy before surgery.I have been diagnosed with a type of breast cancer.My cancer has spread to other parts of my body.I have had radiation therapy on the same side as my current breast cancer.My breast tumor is larger than 3.0 cm.I am 50 or older with triple negative breast cancer.My tests show no cancer in the lymph nodes under my arm.My underarm lymph nodes are suspected to be cancerous, but not yet confirmed by biopsy.I am mostly able to care for myself and carry out daily activities.I have Paget's disease of the nipple.I have not had chemotherapy or radiation for my current breast cancer before joining.I am 40 years old or older.Your body mass index (BMI) is less than 21 when you join the study.My breast cancer is located in just one area.Your weight is higher than what is considered healthy for your height.I speak English or Spanish.My tumor is 3.0 cm or smaller.I have suspicious breast findings not confirmed as benign by biopsy.
- Group 1: Arm I (standard dietary recommendations, SABR, surgery)
- Group 2: Arm II (caloric restriction diet, SABR, surgery)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any openings still available for this research study?
"Affirmative, clinicaltrials.gov attests that this medical experiment is currently recruiting participants. It was initially published on August 23rd 2021 and revised most recently on April 14th 2022. The researchers are looking for 80 individuals from one medical centre to participate in the study."
What potential risks are posed by Stereotactic Body Radiation Therapy?
"The safety of stereotactic body radiotherapy is estimated to be a 2 on the 1-3 scale, as prior clinical data has provided some evidence for its safe use but no indication of efficacy."
What is the size of the sample population for this clinical trial?
"Affirmative. According to the information found on clinicaltrials.gov, this research project is recruiting participants with a starting date of August 23rd 2021 and an updated post from April 14th 2022. 80 individuals are being accepted at 1 medical site for this trial."
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