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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06332508
• Other study ID #: 2022/00406
• Status: Recruiting
• Phase: Phase 1
• Start date: December 30, 2022
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: National University Hospital, Singapore
• Contact: Si Jing, Joline Lim
• Phone: 67737888
• Email: joline_sj_lim[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National University of Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Haidinger 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. — View Citation

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. Erratum In: Front Oncol. 2022 Apr 20;12:892408. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Treatment response as assessed by clinical measurement of tumor size using calipers	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