Table 3.
Characteristics of clinical studies.
| Authors | Tumor Type(s) | Sample Size | Numbers and Characteristics of Groups | Stage | Plasma Device | Direct/Indirect Treatment | Primary OUTCOMES | Secondary Outcomes | Results | Follow-Up |
|---|---|---|---|---|---|---|---|---|---|---|
| Metelmann H.R. et al., 2015 [85] | Advanced HNC | 12 | -Female: 6 -Male: 6 -Caucasian -Age range: 50–77 years. -Karnofsky performance status: 60–80. |
T 4 N 0–3 M 0–1 |
Ar-CAP kINPen MED. | Direct: spot exposure of the ulceration to CAP. | -Change in contamination; -Patient-expressed need of pain medication; -Side effects. |
Anti-cancer effects (tumor growth). | -Relief and reduction of fetid odor and pain; -Bacteria decrease in cancer ulcerations; -not severe side effects; -Visible effects after 2 weeks of exposure on tumor surface. |
N/P |
| Schuster M. et al., 2016 [87] | Advanced HNC | 21 | -Female: 9 -Male: 12 -Caucasian -Age range: 40–77 years. -Karnofsky performance status: 60–80. Group I: (n = 12) palliative CAP treatment Group II: (n = 9) curative CAP + surgery treatment. |
N/P | Ar-CAP kINPen MED. | Direct: spot exposure of the ulceration to CAP. | Tumor surface responses. Type 1: flat area with vascular stimulation; Type 2: contraction of tumor ulceration rims with scabs surrounded by tumor tissue in visible progress. |
Evaluation of CAP-induced visible tumor surface in relation to CAP-induced apoptotic cell kill. | -No sign of enhanced or stimulated tumor growth in any patient; -More apoptotic cells in tissue areas treated with CAP than in untreated; -Visible tumor surface response in relation to apoptotic cell. |
Tumor surface response evaluated by photographic analysis after 2 weeks of treatments. |
| Metelmann H.R. et al., 2018 [15] | Advanced OPSCC | 6 | -Female: 3 -Male: 3 -Age range: 53–78 years |
Locally advanced cancer of the oropharynx (pT4) with contaminated tumor ulcerations. | Ar-CAP kINPen MED. | Direct: spot exposure of the ulceration to CAP. | -Survival time; -Course of disease; -Tumor remission; -Safety of treatment. |
Incisional biopsies were performed to verify changes at the cellular level. | -Tumor reduction; -Significant improvement in tumor decontamination (reduction of odor) and tumor mass; -Palliation in terms of quality of life. |
Related to the death of participant. |
| Schuster M. et al., 2018 [86] | Advanced HNC | 20 | -Female: 10 -Male: 10 -Caucasian -Age range: 49–84 years -Karnofsky performance status: 60–80. |
N/P | Ar-CAP kINPen MED. | Direct: spot exposure of the ulceration to CAP e. | -Evaluation general health condition and side effects; -History of cancer treatment; -State of disease; -Palliation procedure. |
N/P | Side effects were mild to moderate and never life threatening. | N/P |
| Dai X. et al., 2020 [84] | LC | 100 | -Female: 42 -Male: 28 -Age range: 60–85 years old Control: 50 treated with conventional surgery Test: 50 treated with CAP |
N/P | Unitec low-temperature plasma operation system. | Tumor was ablated with a low-temperature plasma cutter with the extent expanded to 3–5 mm away from the edge of the lesion. | -Postoperative efficacy; -Influence on the tumor markers, COX-2, and VEGF expressions. |
-Operation time -VAS pain; -Mucosal recovery scores. |
-Few postoperative complications; -Decreased expression levels of postoperative tumor markers (COX-2 and VEGF). |
N/P |
CAP: cold atmospheric plasma; COX-2: cyclooxygenase-2; HNC: squamous cell carcinoma of the head and neck; LC: laryngeal carcinoma; N/P: not provided; OPSCC: oropharyngeal squamous cell carcinoma; VAS: visual analog scale; VEGF: vascular endothelial growth factor.