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

March 20, 2024 updated by: National University Hospital, Singapore

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center phase Ib study to investigate the safety and tolerability of the combination of PEMF with anthracycline-based chemotherapy. Subjects will be enrolled on a 3+3 dose escalation design from dose level 1 with a target to reach dose level 4, where PEMF can be administered prior to each cycle of anthracycline-based chemotherapy. In the first 2 dose levels, PEMFs will first be administered to subjects who are planned for upfront surgical resection to ensure that PEMFs is safe and tolerable for up to 0.5-hour. Once the duration of each PEMF treatment is established, PEMFs will then be added to anthracycline-based chemotherapy to investigate the safety and tolerability of the combination treatment.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital
        • Contact:
        • Principal Investigator:
          • Joline Si Jing Lim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEMFs prior to surgery
During the study period, subjects will receive local magnetic therapy (PEMFs). The study aims to enrol subjects in 4 groups - in dose level 1 and 2 (subjects who do not need chemotherapy prior to surgery), PEMF will be administered prior to surgery;
Device: Pulsed electromagnetic fields (PEMFs)

Device: PEMFs

PEMFs treatment can be delivered up to 7 days prior to day of surgery (dose levels 1-2) or anthracycline-based chemotherapy (dose levels 3-4) to allow subject flexibility of timing and decrease the need for multiple visits. A research staff will be assigned to be with subject during the duration of PEMFs to monitor for any side effects during treatment.
Experimental: PEMFs prior to chemotherapy
In dose level 3 and 4 (subjects who require chemotherapy), PEMF will be administered prior to chemotherapy.
Device: Pulsed electromagnetic fields (PEMFs)

Device: PEMFs

PEMFs treatment can be delivered up to 7 days prior to day of surgery (dose levels 1-2) or anthracycline-based chemotherapy (dose levels 3-4) to allow subject flexibility of timing and decrease the need for multiple visits. A research staff will be assigned to be with subject during the duration of PEMFs to monitor for any side effects during treatment.

Drug: Anthracycline-based chemotherapy

Drug: Anthracycline-based chemotherapy (doxorubicin, cyclophosphamide)

At dose levels 3 and 4, two cohorts will be opened: the first cohort will undergo surgical resection immediately after completion of anthracycline-based chemotherapy, and the second cohort will undergo taxane-based chemotherapy following completion of anthracycline-based chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0
Time Frame: up to 6 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment response as assessed by clinical measurement of tumor size using calipers
Time Frame: up to 6 months
Subjects should have documented the size of the tumor through clinical measurement using calipers at each assessment visit. Wherever possible, documentation of radiological size based on mammogram, ultrasound or magnetic resonance imaging should also be recorded.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

National University of Singapore

Investigators

  • Principal Investigator: Si Jing, Joline Lim, National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 7, 2022

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/00406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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