Quasi-Feasibility Clinical Trial: Deep Local Hyperthermia with HyDeep 600 WM mHT device & Standard Cancer Treatments
ESHO 2014 Congress Poster: Andromedic Oncological Hyperthermia Device Clinical Study
Quasi feasibility study (case-control) associating deep local hyperthermia HyDeep 600WM treatment with standard cancer treatments.
Introduction
This is the first clinical trial combining deep local hyperthermia with standard cancer treatments in Spain and Andalusia, utilizing modulated RF-hyperthermia (mHT) technology at 13.56 MHz.
Objectives
First: To analyze the clinical benefits, treatment response, treatment feasibility, and comfort with hyperthermia combined with standard cancer treatments within the public health system.
Secondary: To analyze survival, quality of life, and toxicity (general and specific cancer hyperthermia).
Study Design
Design: A prospective, quasi-experimental, case-control study. Hyperthermia treatments (6-10 sessions, 2-3 per week) were administered in conjunction with Radiotherapy (RT), Chemotherapy (CT), or both.
Phases: 1st learning phase (20 patients); 2nd active phase (97 patients) compared with 196 controls from 2012. Total: 293 cancer patients.
9 Targeted Tumor Sites:
- Cervix, prostate, bladder
- Pancreas, inoperable head and neck
- Brain tumors, preoperative rectum
- Neoadjuvant treatment for advanced breast cancer
- Non-small cell lung cancer (NSCLC)
- Palliative treatment at different sites
Results & Preliminary Data
Data Source: 22 preliminary cancer patients (9 at Juan Roman Jimenez Hospital and 13 at Carlos Haya Hospital).
Patient Profile: 13 men / 9 women. Average age: 55 years (34-76 years).
Tumor Locations: Glioblastoma (2c), head and neck (7c), preoperative rectum (3c), breast (3c1), lung (11c), prostate (4c), cervix (lc), sacroiliac bone metastasis.
Hyperthermia Treatment Protocol: HyDeep 600WM advanced oncologic hyperthermia device (Andromedic) administering 10 sessions (1 hour each), 2-3 times/week, using 150W to 400W.
Reasons for Treatment Discontinuation:
- Juan R Jiménez Hospital (Huelva): 3 cases (infection/cellulitis in rectal cancer, uterine bleeding, and voluntary discontinuation).
- Hospital C Haya (Malaga): 2 patients (discontinued at 6th session due to good tolerance and well-tolerated progress).
Patient Outcome & Survival:
19 cancer patients are alive (awaiting evaluation). 3 patients deceased due to disease progression (2 had tumor relapse in previously irradiated head/neck area; 1 had pharyngeal relapse under palliative RT/HT).
Tolerance: 81.2% of cancer patients were satisfied or very satisfied. 18.8% rated it “acceptable”.
Toxicity: Grade 1 burning-like toxicity in 36.3% of cases. 66.6% experienced NO toxicity.
CONCLUSIONS: Modulated RF-hyperthermia is feasible and comfortable for 81.2% of patients in the public health system. Appropriate cancer patient selection is crucial for maximizing outcomes.