CompletedPhase 1

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

Singapore14 participantsStarted 2022-12-30

Plain-language 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.

Who can participate

Age range21 Years – 99 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0

Timeframe: up to 6 months

Trial details

NCT IDNCT06332508

SponsorNational University Hospital, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-08

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