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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
Must not have
Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor
Patient has stage IV metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-12 weeks after biopsy
Awards & highlights

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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have suspicious lymph nodes near my collarbone or breastbone not proven negative by biopsy.
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My cancer has spread to other parts of my body.
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I have had radiation therapy on the same side as my current breast cancer.
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My breast tumor is larger than 3.0 cm.
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My underarm lymph nodes are suspected to be cancerous, but not yet confirmed by biopsy.
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I have Paget's disease of the nipple.
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I have not had chemotherapy or radiation for my current breast cancer before joining.
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I have suspicious breast findings not confirmed as benign by biopsy.

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%
Back pain
29%
Anemia
29%
Vomiting
21%
Lymphocyte count decreased
21%
Anorexia
21%
Chest pain
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Depression
14%
Hypotension
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Dysgeusia
7%
Muscle weakness
7%
Esophagitis
7%
Eye pain
7%
Hemorrhoids
7%
Blurred vision
7%
Rash
7%
Dementia
7%
Dysuria
7%
Lung infection
7%
Throat pain
7%
Alopecia
7%
Hearing impaired
7%
Tachycardia
7%
Bone marrow biopsy
7%
Neuropathy
7%
Hypernatremia
7%
Productive cough
7%
Dehydration
7%
Pneumonitis
7%
Pleuritic pain
7%
Otitis externa
7%
Blood bilirubin increased
7%
Amnesia
7%
Confusion
7%
White blood cell count decreased
7%
Neutropenia
7%
Hypertension
7%
Hypoxia
7%
Floaters
7%
Sinusitis
7%
Creatinine increased
7%
Leukocytosis
7%
Aspiration pneumonia
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Toothache
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Radiation therapy works by damaging the DNA of cancer cells, leading to cell death and reducing tumor size. The trial studying calorie reduction aims to enhance the effectiveness of radiation therapy by potentially making cancer cells more susceptible to radiation damage. Chemotherapy targets rapidly dividing cells, including cancer cells, by interfering with their DNA replication or metabolic processes. Endocrine therapy blocks hormones like estrogen that can promote the growth of hormone receptor-positive breast cancer cells. Targeted therapies, such as HER2 inhibitors, specifically attack cancer cells with certain genetic markers, sparing normal cells. Understanding these mechanisms helps breast cancer patients and their doctors choose the most effective treatment plan tailored to their specific cancer type and condition.
High-dose therapy for breast cancer - a case of suspended animation.

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
452 Previous Clinical Trials
148,807 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
~24 spots leftby Nov 2025