Caloric Restriction + Stereotactic Body Radiation Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Thomas Jefferson University

Disqualifiers: Stage IV, Paget's disease, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Caloric Restriction + Stereotactic Body Radiation Therapy for Breast Cancer?

Research shows that reducing calorie intake can make breast cancer cells more sensitive to radiation therapy, potentially improving treatment outcomes. Studies in animals have demonstrated that combining calorie restriction with radiation therapy leads to greater tumor reduction compared to radiation alone. ^{1 2 3 4 5}

Is the combination of caloric restriction and stereotactic body radiation therapy safe for humans?

Stereotactic body radiation therapy (SABR), including the CyberKnife system, has been used safely in treating various cancers like lung, liver, and kidney tumors, with studies showing acceptable levels of side effects. However, specific safety data on combining SABR with caloric restriction for breast cancer is not available. ^{6 7 8 9 10}

How is the treatment of breast cancer with Stereotactic Body Radiation Therapy (CyberKnife) different from other treatments?

Stereotactic Body Radiation Therapy (SBRT), also known as CyberKnife, is unique because it delivers highly precise radiation doses to tumors while minimizing damage to surrounding healthy tissue. This noninvasive treatment is particularly beneficial for patients who cannot undergo surgery, offering a shorter treatment course with high rates of tumor control. ^{7 8 9 10 11}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

My tumor, including all areas, is 3 cm or smaller.

Willing and able to comply with study treatments including dietary intervention

I am not being considered for chemotherapy before surgery.

Exclusion Criteria

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.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative SABR

Participants undergo stereotactic ablative radiation therapy (SABR) every other day for 5 fractions

2-3 weeks

5 visits (in-person)

Caloric Restriction (Arm II only)

Participants in Arm II undergo a caloric restriction diet for 6-12 weeks, reducing calorie intake by 25%

6-12 weeks

Surgery

Participants undergo surgical resection with sentinel lymph node biopsy within 4-12 weeks of completion of SABR

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up at 3-6 weeks, and then 6 months after surgery

Treatment Details

Interventions

• Dietary Intervention (Behavioural Intervention)
• Stereotactic Body Radiation Therapy (Radiation Therapy)

Trial Overview 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.

Participant Groups

Group I: Arm II (caloric restriction diet, SABR, surgery) Experimental Treatment 6 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 Control 6 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.

Stereotactic Body Radiation Therapy is already approved in Canada for the following indications:

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Thomas Jefferson University Hospital Philadelphia, PA

Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy Philadelphia, PA

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Dr. Eugene Kennedy

Thomas Jefferson University

Chief Medical Officer since 2020

MD

Dr. Joseph G. Cacchione

Thomas Jefferson University

Chief Executive Officer since 2022

MD, MBA

Findings from Research

Calorie restriction (CR), which reduces calorie intake by 20%-40%, has been shown to increase longevity and may also enhance the effectiveness of cancer treatments like radiation and chemotherapy by altering key molecular pathways.

Laboratory and clinical evidence suggests that CR can make breast cancer cells more susceptible to standard treatments, indicating its potential as a complementary intervention in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrient restriction and radiation therapy for cancer treatment: when less is more. Champ, CE., Baserga, R., Mishra, MV., et al.[2021]

Calorie restriction (CR) has been shown to safely extend lifespan and reduce age-related disease risk factors in various organisms, including potential benefits for humans in reducing cancer risk.

Pre-clinical studies suggest that CR may enhance the effectiveness of breast cancer treatments like chemotherapy, radiation, and immunotherapy by improving metabolic health and reducing inflammation, but more clinical research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calorie restriction and breast cancer treatment: a mini-review. Isaac-Lam, MF., DeMichael, KM.[2022]

In murine models of triple-negative breast cancer (TNBC), a daily caloric restriction (CR) of 30% combined with radiation therapy (IR) resulted in greater tumor regression compared to either treatment alone, highlighting the potential of dietary modification as a therapeutic intervention.

Molecular analysis revealed that CR and IR together reduced tumor cell proliferation and increased apoptosis, with downregulation of key components in the IGF-1R pathway, suggesting that targeting this pathway could enhance treatment efficacy for TNBC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caloric restriction augments radiation efficacy in breast cancer. Saleh, AD., Simone, BA., Palazzo, J., et al.[2021]

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

Stereotactic ablative body radiotherapy (SABR) is a feasible and well-tolerated treatment for patients with bone-only oligometastatic breast cancer, with 80% of patients successfully receiving treatment and no severe (grade 3 or 4) toxicities reported.

The treatment showed promising efficacy, with a 100% local progression-free survival (LPFS) and 67% distant progression-free survival (DPFS) at two years, suggesting that SABR could be a viable option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. David, S., Tan, J., Savas, P., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Nutrient restriction and radiation therapy for cancer treatment: when less is more. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Calorie restriction and breast cancer treatment: a mini-review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Caloric restriction augments radiation efficacy in breast cancer. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Calories, carbohydrates, and cancer therapy with radiation: exploiting the five R's through dietary manipulation. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of a diet and physical activity intervention on body weight and nutritional patterns in overweight and obese breast cancer survivors. [2021]

6. Greece pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma patients who failed or were unsuitable for transarterial chemoembolization. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. [2020]

10. Canada pubmed.ncbi.nlm.nih.gov

CyberKnife for inoperable renal tumors: Canadian pioneering experience. [2013]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]