Clinical trial · Interventional
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
NCT06332508CI-TRIAL-00105401completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the safety and tolerability of combined PEMFs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline OR Taxane | Combination Product | — | UNRESOLVED |
| Pulsed electromagnetic fields (PEMFs) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose Level 1 (Metastatic Disease)
- description
- Patients with metastatic disease (Grade 3, Stage III/IV, ER-/HER2+) receive a single PEMF session.
- interventionNames
- Device: Pulsed electromagnetic fields (PEMFs)
- type
- EXPERIMENTAL
- label
- Dose Level 2 (Pre-Surgical)
- description
- Patients planned for upfront surgical resection receive a single PEMF session prior to surgery.
- interventionNames
- Device: Pulsed electromagnetic fields (PEMFs)
- type
- EXPERIMENTAL
- label
- Dose Level 3 (Neoadjuvant Chemotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.References
Publications (2)
- BACKGROUNDTai YK, Chan KKW, Fong CHH, Ramanan S, Yap JLY, Yin JN, Yip YS, Tan WR, Koh APF, Tan NS, Chan CW, Huang RYJ, Li JZ, Frohlich J, Franco-Obregon A. Modulated TRPC1 Expression Predicts Sensitivity of Breast Cancer to Doxorubicin and Magnetic Field Therapy: Segue Towards a Precision Medicine Approach. Front Oncol. 2022 Jan 24;11:783803. doi: 10.3389/fonc.2021.783803. eCollection 2021. PMID 35141145
- BACKGROUNDHaidinger R, Bauerfeind I. Long-Term Side Effects of Adjuvant Therapy in Primary Breast Cancer Patients: Results of a Web-Based Survey. Breast Care (Basel). 2019 Apr;14(2):111-116. doi: 10.1159/000497233. Epub 2019 Feb 15. PMID 31798383