What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as radiation therapy and endocrine therapy, have several known side effects. Radiation therapy can cause acute toxicity, including skin irritation, fatigue, and changes in breast appearance. Long-term effects may include fibrosis and, rarely, secondary cancers. Endocrine therapies like tamoxifen and aromatase inhibitors can lead to hot flashes, bone density loss, cardiovascular risks, and, in some cases, an increased risk of endometrial cancer. Combining these treatments with dietary interventions, such as calorie reduction, is being studied to potentially enhance their effectiveness while monitoring for any additional side effects.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including targeted therapies, hormone therapies, and chemotherapy. Notably, stereotactic ablative radiation therapy (SABR) is a highly focused radiation treatment that has been studied for its effectiveness in treating breast cancer. While specific FDA approvals for calorie reduction combined with SABR are not detailed, the combination of innovative radiation techniques with other therapeutic approaches continues to be an area of active research. Additionally, drugs like trastuzumab deruxtecan and trastuzumab emtansine have been approved for HER2-positive metastatic breast cancer, showcasing the FDA's commitment to advancing targeted and effective treatments.

What other types of research exist?

Promising novel alternatives to calorie reduction for enhancing the effectiveness of radiation therapy in breast cancer patients include the use of targeted therapies such as T-DM1 (trastuzumab emtansine) and the combination of lapatinib plus capecitabine. These therapies have shown efficacy in treating brain metastases and may offer benefits in other contexts. Additionally, the integration of exercise and dietary therapy has been explored as a feasible alternative to cognitive behavior therapy in the treatment of eating disorders, which may also have implications for cancer treatment.

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Radiation Therapy

Caloric Restriction + Stereotactic Body Radiation Therapy for Breast Cancer

N/A

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 up to 6 months after sabr

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a calorie-restricted diet combined with a precise radiation treatment can better shrink breast cancer tumors. The goal is to see if this combination makes the tumor smaller and less likely to spread compared to using radiation alone.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months after sabr

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months after sabr

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months after sabr for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent reduction in cellularity of breast tumor

Secondary study objectives

Change in patient-reported health-related quality of life

Change in tumor

Feasibility of identifying sentinel lymph node (SLN)

+4 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

87%

Fatigue

53%

Nausea

33%

Cough

27%

Pain

27%

Anemia

27%

Fall

27%

Dyspnea

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

20%

Chills

20%

Edema limbs

20%

Dizziness

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

13%

Skin infection

13%

Dysesthesia

13%

Edema

13%

Insomnia

13%

Constipation

13%

Delirium

13%

Dysgeusia

13%

Myalgia

13%

Vomiting

13%

Tinnitus

13%

Rash

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Proteinuria

Bruising

Hearing loss

Anxiety

Headaches

Oral lesions

Weakness (facial)

Neutrophil count decreased

Acute kidney injury

Hypokalemia

Lymphocytopenia

Seizures

Hearing impaired

Hypernatremia

Creatinine increased

Headache

Pleural effusion

Death NOS

Gait disturbance

Nasal congestion

Fever

Tremor

Urinary urgency

Hypoxic respiratory failure

Amnesia

Photophobia

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Erythema multitforme

Lung infection

Hypertension

Allergy (seasonal)

Muscle weakness

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

Study treatment Arm

Maintenance Chemotherapy

Stereotactic Body Radiation Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 Control6 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

2020

Completed Phase 2

~1440

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790

Sentinel Lymph Node Biopsy

2004

Completed Phase 3

~350

0 / 16Eligibility criteria met

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.