NCT06332508

Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: Female
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and tolerability of combined PEMFs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment.

Detailed description

This was a single-center, open-label, Phase Ib study utilizing a 3+3 dose-escalation design. Patients with histologically confirmed ductal carcinoma were enrolled into three sequential cohorts. Dose Level 1 (DL1) enrolled patients with metastatic disease (Grade 3, Stage III/IV, ER-/HER2+) for a single 30-minute PEMF session to assess local toxicity. Dose Level 2 (DL2) enrolled patients were planned for upfront surgical resection (Grade 1-2, ER+/PR+) to assess wound-healing safety; PEMF was administered 30 minutes pre-surgery. Dose Level 3 (DL3) enrolled patients undergoing neoadjuvant chemotherapy (Grade 3, Stage I-III) to receive PEMF 30 minutes prior to their final cycle (4th cycle) of either Anthracycline (DL3a) or Taxane (DL3b) therapy. The primary endpoints were safety and incidence of device-related adverse events. The trial ended at Dose Level 3 and demonstrates that a 30-minute PEMF application is safe and well-tolerated in breast cancer patients across metastatic, pre-surgical, and neoadjuvant chemotherapy settings. The intervention had no adverse effect on surgical wound healing or on chemotherapy administration. These findings support the closure of the Phase I safety evaluation and justify progression to a Phase II trial to evaluate the efficacy of PEMF in enhancing chemotherapeutic response.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Pulsed electromagnetic fields (PEMFs)	A single 30-minute PEMF session to assess local toxicity.
DEVICE	Pulsed electromagnetic fields (PEMFs)	A single 30-minute PEMF session administered 30 minutes pre-surgery to assess wound-healing safety.
COMBINATION_PRODUCT	Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline OR Taxane	A single 30-minute PEMF session administered 30 minutes prior to the final cycle (4th cycle) of either Anthracycline (DL3a) or Taxane (DL3b) therapy.

Timeline

• Start date: 2022-12-30
• Primary completion: 2025-08-08
• Completion: 2025-08-08
• First posted: 2024-03-27
• Last updated: 2026-03-13

Locations

1 site across 1 country: Singapore