Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL)
1 other identifier
interventional
14
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 breast-cancer
Started Dec 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2022
CompletedStudy Start
First participant enrolled
December 30, 2022
CompletedFirst Posted
Study publicly available on registry
March 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2025
CompletedMarch 13, 2026
August 1, 2025
2.6 years
October 7, 2022
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0
Toxicity to treatment as assessed by Common Terminology Criteria for Adverse Events 5.0. Grade 1-5 refer to the severity of the adverse event with higher grade indicating greater severity. Grade 3 and above will be considered severe. A dose limiting toxicity will be defined as Grade 3 or above toxicity of the following: a) pain in breast where PEMF was applied * Increased intra-operatively bleeding whereby surgical bed require a longer period of hemostases * Post-surgical complications including delay wound healing (open wound of more than 5 days post-surgery), wound infection and wound dehiscence, hematoma formation
up to 6 months
Secondary Outcomes (1)
Treatment response as assessed by clinical measurement of tumor size using calipers
up to 6 months
Study Arms (3)
Dose Level 1 (Metastatic Disease)
EXPERIMENTALPatients with metastatic disease (Grade 3, Stage III/IV, ER-/HER2+) receive a single PEMF session.
Dose Level 2 (Pre-Surgical)
EXPERIMENTALPatients planned for upfront surgical resection receive a single PEMF session prior to surgery.
Dose Level 3 (Neoadjuvant Chemotherapy
EXPERIMENTALPatients undergoing neoadjuvant chemotherapy receive a single PEMF session prior to their final chemotherapy cycle. This cohort is subdivided into those receiving Anthracycline (DL3a) and those receiving Taxane (DL3b).
Interventions
A single 30-minute PEMF session to assess local toxicity.
A single 30-minute PEMF session administered 30 minutes prior to the final cycle (4th cycle) of either Anthracycline (DL3a) or Taxane (DL3b) therapy.
Eligibility Criteria
You may qualify if:
- Histologically confirmed breast carcinoma of any subtype (any estrogen receptor, progesterone receptor and HER2 receptor status)
- ECOG 0-1.
- Non-metastatic disease for which surgery of curative intent is planned upfront or after completion of neoadjuvant chemotherapy
- Adequate organ function including the following:
- Bone marrow:
- Absolute neutrophil (segmented and bands) count (ANC) \>= 1.5 x 10\^9/L
- Platelets \>= 100 x 10\^9/L
- Hemoglobin \>= 8 x 10\^9/L
- Hepatic:
- Bilirubin \<= 1.5 x upper limit of normal (ULN),
- ALT or AST \<= 2.5x ULN, (or \<=5 X with liver metastases)
- Renal:
- Creatinine \<= 1.5x ULN
- Signed informed consent from subject or legal representative.
- Able to comply with study-related procedures.
You may not qualify if:
- Pregnancy.
- Breast feeding.
- Presence of fungating breast tumor or open wound in breast planned for PEMF.
- Active bleeding disorder or bleeding site.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Major surgery within 28 days prior to study administration.
- Non-healing wound.
- Active infection that in the opinion of the investigator would compromise the subject's ability to tolerate therapy.
- History of significant neurological or mental disorder, including seizures or dementia.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National University Hospital
Singapore, Singapore, 119074, Singapore
Related Publications (2)
Tai 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: 35141145BACKGROUNDHaidinger 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: 31798383BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel Wong, Medical Degree
National University Hospital, Singapore
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2022
First Posted
March 27, 2024
Study Start
December 30, 2022
Primary Completion
August 8, 2025
Study Completion
August 8, 2025
Last Updated
March 13, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share