Caloric Restriction + Stereotactic Body Radiation Therapy for Breast Cancer

Recruiting at 1 trial location

Overseen By Nicole Simone, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Stage IV, Paget's disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether reducing calorie intake can enhance the effectiveness of stereotactic ablative radiation therapy (sABR) in treating breast cancer. The aim is to determine if a calorie-restricted diet combined with sABR can shrink tumors more effectively before surgery compared to sABR alone. Participants will either follow standard dietary advice or reduce their calorie intake by 25% during radiation therapy. The trial seeks participants with specific types of breast cancer, a tumor size of 3 cm or smaller, and a body mass index (BMI) of 21 or higher. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could improve future breast cancer treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a diet with fewer calories is generally safe for breast cancer patients. One study found that patients on this diet did not experience harmful changes in their bodies, suggesting it is well-tolerated. This diet might even help protect against breast cancer.

Stereotactic Body Radiation Therapy (SBRT) offers another treatment option that has been studied for safety. Research indicates that SBRT provides a safe and non-invasive way to treat various cancers, including breast cancer. It focuses radiation on tumors while avoiding damage to nearby healthy tissues. Studies have shown it effectively targets the tumor without causing issues in other areas.

Combining both treatments aims to enhance treatment effectiveness while ensuring patient safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this protocol because it combines stereotactic body radiation therapy (SABR) with dietary interventions to potentially enhance treatment outcomes for breast cancer. Unlike standard treatments, which typically focus on surgery, chemotherapy, and radiation therapy, this approach introduces a caloric restriction diet alongside SABR. The diet aims to reduce calorie intake by 25% during the treatment period, which is thought to enhance the effectiveness of radiation therapy. By exploring how caloric restriction might improve treatment response, researchers hope to uncover new ways to boost the efficacy of existing cancer therapies and improve patient outcomes.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research shows that eating fewer calories might enhance the effectiveness of breast cancer treatments. Studies have found that breast cancer patients who reduce calorie intake respond better to chemotherapy, both in the breast and nearby lymph nodes. Eating less has also been linked to slowing tumor growth and reducing cancer spread. In this trial, some participants will follow a caloric restriction diet alongside Stereotactic Body Radiation Therapy (SABR).

SABR is a type of radiation treatment that precisely targets tumors while sparing nearby healthy tissue. It has significantly shrunk tumors and improved survival rates in some breast cancer patients. In this trial, all participants will receive SABR, but only some will follow the caloric restriction diet. Overall, both approaches show promise in improving outcomes for breast cancer patients. ^{1 3 6 7 8}

Who Is on the Research Team?

Nicole Simone, MD

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Are You a Good Fit for This Trial?

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 suspicious lymph nodes near my collarbone or breastbone not proven negative by biopsy.

I have a few cancer spread sites and my doctor is treating me to cure.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Intervention
• Stereotactic Body 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.

How Is the Trial Designed?

Group I: Arm II (caloric restriction diet, SABR, surgery) Experimental Treatment 8 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 8 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 United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

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

Approved in European Union as Stereotactic Body Radiation Therapy for:

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

Approved in Canada as Stereotactic Body Radiation Therapy for:

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

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Published Research Related to This Trial

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

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. Heal, C., Ding, W., Lamond, J., et al.[2020]

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]

A lifestyle intervention involving diet and physical activity led to significant weight loss (5.6 kg) and improvements in body composition among 37 overweight and obese breast cancer survivors who completed the program.

Participants showed substantial reductions in energy and fat intake, along with improvements in quality of life and cardiorespiratory fitness, indicating the intervention's effectiveness in promoting healthier lifestyles post-treatment.

NCBI (Pubmed)

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. Travier, N., Fonseca-Nunes, A., Javierre, C., et al.[2021]

CyberKnife stereotactic ablative body radiotherapy (SABR) was successfully used to treat three patients with kidney tumors, achieving local control in all cases without any reported toxicity.

The treatment preserved kidney function, demonstrating that CyberKnife SABR is a safe and effective option for patients with medically inoperable renal tumors or those with tumors in a solitary kidney.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife for inoperable renal tumors: Canadian pioneering experience. Nair, VJ., Szanto, J., Vandervoort, E., et al.[2013]

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]

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) is an effective treatment for early-stage non-small cell lung cancer, especially for patients who cannot undergo surgery, showing high local tumor control rates with manageable side effects.

The CyberKnife system is particularly advantageous for SABR in lung tumors due to its ability to accurately target moving tumors during breathing, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. Gibbs, IC., Loo, BW.[2022]

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) and very low carbohydrate ketogenic diets (KDs) may enhance the effectiveness of radiation therapy by improving DNA repair in normal cells while inhibiting tumor cell repopulation, as evidenced by various animal and human studies.

These dietary interventions can potentially improve the therapeutic window in cancer treatment by normalizing tumor vasculature and increasing the radioresistance of normal cells while decreasing that of tumor cells, suggesting a synergistic effect with radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Cyberknife stereotactic ablative radiotherapy (SABR) demonstrated a 71.6% objective response rate in 53 patients with unresectable hepatocellular carcinoma (HCC), indicating its efficacy as a salvage treatment when other therapies failed.

The median survival time for patients treated with SABR was 20 months, with 1- and 2-year overall survival rates of 70.1% and 45.4%, respectively, suggesting that while SABR is effective, there is a need to address issues like out-field recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma patients who failed or were unsuitable for transarterial chemoembolization. Lo, CH., Huang, WY., Lee, MS., 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]

Citations

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Impact of Caloric Restriction in Breast Cancer Patients ... Recently, several studies have demonstrated that CR may have a favorable impact on the response to systemic therapy in breast cancer (BC) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10648206/

Impact of Caloric Restriction in Breast Cancer Patients ... Conclusions: Patients who adhered to CR showed a better response to NACT, both in the breast and in the axillary lymph nodes, compared to the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01819233

Caloric Restriction in Treating Patients With Stage 0-I ... Reducing caloric intake may prevent disease progression in patients with breast cancer. Radiation therapy uses high energy x rays to kill tumor cells.

4. nature.com nature.com/articles/s41467-021-26431-4

Daily caloric restriction limits tumor growth more effectively ... Caloric restriction (CR) is the most effective intervention to reduce the incidence and progression of most spontaneous and induced cancers. Due ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S089990072030112X

Assessing successful completion of calorie restriction ... Calorie restriction (CR) >20% has been hypothesized to aid cancer prevention and treatment. Yet, to our knowledge, there is a lack of reported studies in ...

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Overeating, caloric restriction and breast cancer risk by ... Our results suggest that restricted caloric intake offers a protective effect against breast cancer, especially in premenopausal women, whereas ...

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Feasibility of dietary intervention in a breast cancer ... Background: Caloric restriction (CR), or reducing caloric intake by 20-40%, induces molecular changes which are also altered in breast cancer leaving cancer ...

8. jcpjournal.org jcpjournal.org/journal/view.html?uid=877&vmd=Full

Calorie Restriction for Cancer Prevention and Therapy Preliminary clinical studies show that patients subjected to a reduced nutrient/energy intake experience improved outcomes from chemo- and ...