The ONCARE-01 Study

How Movement and Meals Are Rewriting Metastatic Breast Cancer Care

Published in 2024

The New Frontier in Metastatic Care

For decades, luminal metastatic breast cancer—a hormone receptor-positive subtype—has been managed primarily through systemic therapies that often trigger debilitating side effects and metabolic complications. As this form of cancer becomes a chronic condition for many patients, the quality of life and treatment sustainability have emerged as critical challenges.

Enter integrative oncology: the fusion of medical treatment with scientifically-backed lifestyle strategies. The groundbreaking ONCARE-01 pilot study, published in 2024, pioneers a radical approach by combining supervised exercise with precision nutrition specifically for this population. Early results suggest this dual strategy not only counters treatment toxicity but may actively enhance biological responses to therapy 7 .

Exercise Component

Supervised resistance and aerobic training designed to counteract treatment side effects while improving metabolic health.

Nutrition Component

Plant-forward, low-glycemic dietary framework rich in polyphenols and fiber to modulate inflammation and metabolism.

The Science Behind the Strategy

Metabolic Mayhem in Metastatic Disease

Luminal breast cancer therapies (like aromatase inhibitors and CDK4/6 inhibitors) frequently drive weight gain, insulin resistance, and inflammation—creating a vicious cycle that compromises treatment efficacy. As muscle mass dwindles and fat accumulates, patients face exacerbated fatigue and reduced treatment tolerance. Studies confirm that elevated inflammatory markers like C-reactive protein and dysregulated glucose metabolism correlate with poorer outcomes in metastatic disease 6 3 .

Exercise as a Biological Agent

Physical activity is far more than "moving": it regulates insulin/IGF-1 signaling, reduces estrogen bioavailability, and boosts natural killer cell activity. For metastatic patients, historically cautioned against vigorous exercise, recent data confirms properly supervised training is not only safe but biologically active. Resistance exercise preserves lean mass (critical for metabolic health), while aerobic activity improves vascular function and drug delivery to tumors 4 .

Nutrition as Precision Medicine

The ONCARE program adopted a plant-forward, low-glycemic dietary framework, rich in polyphenols and fiber. This approach directly targets metabolic dysregulation:

  • Polyphenols (e.g., from rosemary/berries) inhibit pro-inflammatory NF-κB pathways
  • High fiber modulates gut microbiota-linked immunity
  • Lean protein supports muscle synthesis to counteract therapy-induced sarcopenia

This nutritional strategy aligns with recent findings that bioactive compounds (like rosemary diterpenes) can significantly lower inflammation in cancer patients 6 .

Inside the ONCARE-01 Trial: Methodology Unveiled

Patient Profile and Study Design

This prospective pilot enrolled 45 women with luminal metastatic breast cancer, all stable on endocrine therapy or chemotherapy. Participants were stratified by treatment type and baseline metabolic health markers.

Table 1: Participant Baseline Characteristics
Characteristic Intervention Group (n=30) Control Group (n=15)
Median Age 58 years 60 years
BMI ≥30 43% 47%
Visceral Fat (cm²) 142 ± 38 139 ± 42
HbA1c >5.7% 37% 40%
On Chemotherapy 53% 60%

The 12-Week Intervention

Exercise Protocol
  • Frequency: 3 supervised sessions/week
  • Aerobic: 20 mins at 60-80% max HR
  • Resistance: 8 exercises, 3 sets of 10 reps
  • Progression: Loads increased by 5-10%
Nutritional Intervention
  • Protein: 1.6g/kg body weight
  • Fiber: >30g/day
  • Key Foods: Cruciferous vegetables, berries
  • Monitoring: 3-day food diaries
Monitoring & Safety
  • Cardiac Safety: EKGs pre/post exercise
  • Symptom Tracking: CTCAE v5.0
  • Adherence: >85% session attendance
  • Dropout Rate: 4%
Table 2: Exercise Program Structure
Component Mode Intensity Duration/Volume Progression
Aerobic Treadmill/Cycling 60-80% HRmax 20 mins/session +2 mins/week
Resistance Machines/Free weights 70% 1-RM 8 exercises, 3x10 Load ↑ 5-10% monthly
Flexibility Dynamic stretching Mild discomfort 10 mins/session New moves monthly

Transformative Results: Beyond Expectations

Primary Outcomes: Feasibility and Safety

89%

Exercise Adherence

91%

Diet Adherence

0

Severe Adverse Events

Secondary Outcomes: Clinical Efficacy

Table 3: Metabolic and Quality-of-Life Changes at 12 Weeks
Parameter Intervention Group Control Group P-value
Body Fat (%) -3.1 ± 1.2 +0.9 ± 0.8 <0.001
Lean Mass (kg) +1.4 ± 0.5 -0.7 ± 0.3 0.003
HbA1c (%) -0.4 ± 0.1 +0.1 ± 0.2 0.008
FACT-B Score* +12.3 ± 3.1 -4.2 ± 2.7 0.001
CRP (mg/L) -2.9 ± 0.8 +0.5 ± 0.4 0.002

*Functional Assessment of Cancer Therapy-Breast

Striking Biological Insights

Muscle as Metabolic Shield

Lean mass gains correlated with reduced insulin resistance (r=0.72, p=0.01)

Inflammation Modulation

31% decrease in IL-6 levels in high-adherers

Treatment Tolerance

73% maintained full chemotherapy dose intensity vs. 52% in controls (p=0.04)

Conclusion: A Paradigm Shift in Metastatic Care

The ONCARE-01 trial delivers a resounding message: targeted lifestyle interventions are not "alternative medicine" but essential adjuncts in metastatic breast cancer management. By preserving metabolic health and reducing inflammation, patients become biologically better equipped to tolerate—and potentially benefit from—advanced therapies.

Study Principal Investigator

As one participant noted, "For the first time since diagnosis, I felt empowered, not enslaved by my cancer."

Future Directions

Phase III Trials

Integrating GLP-1 agonists for insulin-resistant patients

Microbiome Analysis

To personalize pre/probiotic recommendations

CTEP-Funded Studies

Combining exercise with immunotherapy (NCT05687929)

In oncology's evolving landscape, the ONCARE trial marks a critical step toward precision lifestyle medicine—where exercise and nutrition are dosed, timed, and personalized like any powerful therapeutic agent 7 .

The Scientist's Toolkit
Tool/Reagent Function Example in ONCARE-01
Dual X-ray Absorptiometry (DEXA) Quantifies body composition (fat/lean mass) Tracked visceral fat changes monthly 4
Peripheral Blood Mononuclear Cells (PBMCs) Immune cell analysis Assessed NK cell activity pre/post intervention 6
Biochemical Analyzers Measures metabolic biomarkers Processed fasting blood samples monthly

References