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Radiation Therapy
Caloric Restriction + Stereotactic Body Radiation Therapy for Breast Cancer
Phase 2
Recruiting
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with pathologically proven DCIS or invasive breast cancer histologies
Patients with triple negative breast cancer (TNBC) must be >= 50 years of age at time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-12 weeks after biopsy
Awards & highlights
Study Summary
This trial is studying the effect of calorie reduction on patients with breast cancer undergoing stereotactic ablative radiation therapy.
Who is the study for?
This trial is for individuals aged 40 or older with confirmed ductal carcinoma in situ (DCIS) or invasive breast cancer, clinically node-negative, and a tumor size <=3 cm. Participants must not have had prior radiation or chemotherapy for their current diagnosis, have a BMI >=21, be willing to follow dietary restrictions alongside treatment, and speak English or Spanish. Those with triple negative breast cancer must be at least 50 years old.Check my eligibility
What is being tested?
The study examines the impact of calorie reduction during pre-operative stereotactic ablative radiation therapy (sABR) on patients with early-stage breast cancer. It aims to see if this combination can shrink tumors more effectively than sABR alone before surgery.See study design
What are the potential side effects?
Potential side effects may include typical reactions from radiation therapy such as skin changes, fatigue, mild swelling and potential nutritional deficiencies or other issues related to caloric restriction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of breast cancer.
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I am 50 or older with triple negative breast cancer.
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My tests show no cancer in the lymph nodes under my arm.
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I am mostly able to care for myself and carry out daily activities.
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I am 40 years old or older.
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My breast cancer is located in just one area.
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I speak English or Spanish.
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My tumor is 3.0 cm or smaller.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-12 weeks after biopsy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-12 weeks after biopsy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent reduction in cellularity of breast tumor
Side effects data
From 2022 Phase 2 trial • 29 Patients • NCT0204544679%
Cough
64%
Dyspnea
64%
Nausea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Back pain
29%
Anemia
29%
Vomiting
21%
Anorexia
21%
Lymphocyte count decreased
21%
Chest pain
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Blurred vision
7%
Creatinine increased
7%
Alopecia
7%
Confusion
7%
Sinusitis
7%
Dysgeusia
7%
Hemorrhoids
7%
Dementia
7%
Productive cough
7%
Dysuria
7%
Throat pain
7%
Hearing impaired
7%
Rash
7%
Bone marrow biopsy
7%
Hypernatremia
7%
Eye pain
7%
Tachycardia
7%
Lung infection
7%
Amnesia
7%
Neuropathy
7%
Dehydration
7%
Pneumonitis
7%
Pleuritic pain
7%
Otitis externa
7%
White blood cell count decreased
7%
Neutropenia
7%
Hypertension
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Esophagitis
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (caloric restriction diet, SABR, surgery)Experimental Treatment6 Interventions
Beginning 1 week before the start of SABR, patients undergo a caloric restriction diet for 6-12 weeks (for the duration of radiation treatment, until post radiation follow-up appointment) consisting of reducing calorie intake by 25%. Patients undergo SABR every other day for 5 fractions. Within 4-12 weeks of completion of SABR, patients undergo surgical resection with sentinel lymph node biopsy.
Group II: Arm I (standard dietary recommendations, SABR, surgery)Active Control5 Interventions
Patients receive standard dietary recommendations. Patients undergo SABR every other day for 5 fractions. Within 4-12 weeks of completion of SABR, patients undergo surgical resection with sentinel lymph node biopsy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resection
2023
Completed Phase 2
~420
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Sentinel Lymph Node Biopsy
2004
Completed Phase 3
~330
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
451 Previous Clinical Trials
148,598 Total Patients Enrolled
5 Trials studying Breast Cancer
607 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (standard dietary recommendations, SABR, surgery)
- Group 2: Arm II (caloric restriction diet, SABR, surgery)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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