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Trial Title:
Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL)
NCT ID:
NCT06332508
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Pulsed Electromagnetic Fields (PEMFs)
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Pulsed electromagnetic fields (PEMFs)
Description:
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.
Arm group label:
PEMFs prior to chemotherapy
Arm group label:
PEMFs prior to surgery
Intervention type:
Drug
Intervention name:
Anthracycline-based chemotherapy
Description:
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.
Arm group label:
PEMFs prior to chemotherapy
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 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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
Breast cancer study - 99.9% breast cancer subjects are female. Male breast cancer is
extremely rare and thus males will not be recruited
Minimum age:
21 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National University Hospital
Address:
City:
Singapore
Zip:
119074
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Joline Si Jing Lim
Phone:
69082222
Email:
joline_sj_lim@nuhs.edu.sg
Investigator:
Last name:
Joline Si Jing Lim
Email:
Principal Investigator
Start date:
December 30, 2022
Completion date:
December 2025
Lead sponsor:
Agency:
National University Hospital, Singapore
Agency class:
Other
Collaborator:
Agency:
National University of Singapore
Agency class:
Other
Source:
National University Hospital, Singapore
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06332508
