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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
Gross disease may be multifocal as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension =< 3 cm
Patient is not being considered for preoperative chemotherapy
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 below
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My tumor, including all areas, is 3 cm or smaller.
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I am not being considered for chemotherapy before surgery.
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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 weeks
Treatment ~ Varies
Follow Up ~4-12 weeks after biopsy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-12 weeks after biopsy for reporting.

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 • NCT02045446
79%
Cough
64%
Nausea
64%
Dyspnea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Lymphocyte count decreased
21%
Chest pain
21%
Death NOS
21%
Anorexia
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Dysphagia
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Hemorrhoids
7%
Amnesia
7%
Dehydration
7%
Dysuria
7%
Hypertension
7%
Creatinine increased
7%
Dysgeusia
7%
Confusion
7%
Dementia
7%
Hypernatremia
7%
Productive cough
7%
Pneumonitis
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Blurred vision
7%
Hearing impaired
7%
Rash
7%
Eye pain
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Sinusitis
7%
Alopecia
7%
Esophagitis
7%
Otitis externa
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
2021
Completed Phase 2
~410
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
443 Previous Clinical Trials
145,420 Total Patients Enrolled
5 Trials studying Breast Cancer
607 Patients Enrolled for Breast Cancer

Media Library

Stereotactic Body Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04959474 — Phase 2
Breast Cancer Research Study Groups: Arm I (standard dietary recommendations, SABR, surgery), Arm II (caloric restriction diet, SABR, surgery)
Breast Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT04959474 — Phase 2
Stereotactic Body Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04959474 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~30 spots leftby Nov 2025