Using pulsed electromagnetic fields with chemotherapy for breast cancer treatment

Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL), First-in-man Phase 1 Safety Trials

This study is testing if adding pulsed electromagnetic fields to chemotherapy can be safe and helpful for people with breast cancer who are starting treatment.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 21 Years to 99 Years
• Sex: Female
• Sponsor: National University Hospital, Singapore (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Singapore)
• Trial ID: NCT06332508 on ClinicalTrials.gov

What this trial studies

This phase Ib clinical trial aims to evaluate the safety and tolerability of combining pulsed electromagnetic fields (PEMFs) with anthracycline-based chemotherapy in patients undergoing neoadjuvant treatment for breast cancer. The study will follow a 3+3 dose escalation design, starting with lower doses of PEMFs administered prior to chemotherapy cycles. The goal is to determine the maximum tolerated dose of PEMFs while ensuring patient safety and tolerability. Participants will be closely monitored throughout the treatment process to assess any adverse effects.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed non-metastatic breast cancer who are scheduled for curative surgery and have adequate organ function.

Not a fit: Patients with metastatic disease, active bleeding disorders, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the effectiveness of chemotherapy while minimizing side effects for breast cancer patients.

How similar studies have performed: While the combination of PEMFs with chemotherapy is a novel approach, similar studies exploring electromagnetic therapies have shown promise in other cancer treatments.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed breast carcinoma of any subtype (any estrogen receptor, progesterone receptor and HER2 receptor status)
2. ECOG 0-1.
3. Non-metastatic disease for which surgery of curative intent is planned upfront or after completion of neoadjuvant chemotherapy
4. Adequate organ function including the following:

   1. Bone marrow:

      1. Absolute neutrophil (segmented and bands) count (ANC) \>= 1.5 x 10\^9/L
      2. Platelets \>= 100 x 10\^9/L
      3. Hemoglobin \>= 8 x 10\^9/L
   2. Hepatic:

      1. Bilirubin \<= 1.5 x upper limit of normal (ULN),
      2. ALT or AST \<= 2.5x ULN, (or \<=5 X with liver metastases)
   3. Renal:

      1. Creatinine \<= 1.5x ULN
5. Signed informed consent from subject or legal representative.
6. Able to comply with study-related procedures.

Exclusion Criteria:

1. Pregnancy.
2. Breast feeding.
3. Presence of fungating breast tumor or open wound in breast planned for PEMF.
4. Active bleeding disorder or bleeding site.
5. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
6. Major surgery within 28 days prior to study administration.
7. Non-healing wound.
8. Active infection that in the opinion of the investigator would compromise the subject's ability to tolerate therapy.
9. History of significant neurological or mental disorder, including seizures or dementia.
10. Serious concomitant disorders that would compromise the safety of the subject or compromise the subject's ability to complete the study, at the discretion of the investigator.

Where this trial is running

Singapore

• National University Hospital — Singapore, Singapore (RECRUITING)

Study contacts

• Principal investigator: Si Jing, Joline Lim — National University Hospital, Singapore
• Study coordinator: Si Jing, Joline Lim

Conditions: Breast Cancer, Pulsed Electromagnetic Fields