Acupuncture in the treatment of acute toxicity during and after head and neck cancer radiotherapy: Interim analysis of randomized prospective open-label trial
Aims: The aim of this investigator-initiated prospective randomized open-label single institutional trial is to evaluate the role of acupuncture in the treatment of acute skin and mucosal toxicity, xerostomia, and perception of taste, pain, and nausea related to curative and adjuvant (chemo)radiothe...
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| Format: | Article |
| Language: | English |
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Palacký University Olomouc, Faculty of Medicine and Dentistry
2020-12-01
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| Series: | Biomedical Papers |
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| Online Access: | https://biomed.papers.upol.cz/artkey/bio-202004-0014_acupuncture-in-the-treatment-of-acute-toxicity-during-and-after-head-and-neck-cancer-radiotherapy-interim-anal.php |
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| author | Radana Dymackova Tomas Kazda Marek Slavik Iveta Selingerova Pavel Slampa Ondrej Slama |
| author_facet | Radana Dymackova Tomas Kazda Marek Slavik Iveta Selingerova Pavel Slampa Ondrej Slama |
| author_sort | Radana Dymackova |
| collection | DOAJ |
| description | Aims: The aim of this investigator-initiated prospective randomized open-label single institutional trial is to evaluate the role of acupuncture in the treatment of acute skin and mucosal toxicity, xerostomia, and perception of taste, pain, and nausea related to curative and adjuvant (chemo)radiotherapy of head and neck cancer. This paper reports pilot data of the first 30 enrolled patients. Methods: Patients were randomized to undergo standard of care radiotherapy ± chemotherapy and support care defined by our institutional standard operating procedures alone or in the combination with acupuncture which was initiated with the first signs of any toxicity. Results: Fifteen patients were enrolled in both arms and all finished the treatment as planned.The median pain was significantly lower in the acupuncture arm (median 1.6 points vs. 2.5 points on a 10-item Likert scale; P=0.035) as well as duration of acute pain (median 31 days vs. 54 days; P=0.031). Patients with acupuncture had significantly shorter duration of acute skin (median 44 days vs. 109 days; P<0.001) and mucosal toxicity (median 34 days vs. 109 days; P<0.001) with no difference in grading of toxicity (median grade 1.6 vs. 1.5; P=0.701 and median grade 1.4 vs. 1.6; P=0.204 for skin and mucosa, respectively). No significant difference was found for other toxicity domains, with the exception of salivation toxicity which was significantly lower in acupuncture arm (median grade 1.3 vs. 1.7; P=0.048). Conclusion: In this interim analysis, acupuncture leads to lower pain andfaster disappearance of skin and mucosal toxicity after (chemo)radiotherapy of head and neck cancer. Description and validation of acupuncture using scientific approaches will further enhance acceptance of this method by both patients and health care providers. Trial Registration: Clinicaltrials.gov - NCT03751566 |
| first_indexed | 2024-12-17T04:52:00Z |
| format | Article |
| id | doaj.art-6cbc257f578d426880c857ccaa00ddc7 |
| institution | Directory Open Access Journal |
| issn | 1213-8118 1804-7521 |
| language | English |
| last_indexed | 2024-12-17T04:52:00Z |
| publishDate | 2020-12-01 |
| publisher | Palacký University Olomouc, Faculty of Medicine and Dentistry |
| record_format | Article |
| series | Biomedical Papers |
| spelling | doaj.art-6cbc257f578d426880c857ccaa00ddc72022-12-21T22:02:52ZengPalacký University Olomouc, Faculty of Medicine and DentistryBiomedical Papers1213-81181804-75212020-12-01164445446010.5507/bp.2020.021bio-202004-0014Acupuncture in the treatment of acute toxicity during and after head and neck cancer radiotherapy: Interim analysis of randomized prospective open-label trialRadana Dymackova0Tomas Kazda1Marek Slavik2Iveta Selingerova3Pavel Slampa4Ondrej Slama5Department of Radiation Oncology, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech RepublicDepartment of Radiation Oncology, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech RepublicDepartment of Radiation Oncology, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech RepublicRegional Center for Applied Molecular Oncology (RECAMO), Masaryk Memorial Cancer Institute, Zluty kopec 7, 656 53 Brno, Czech RepublicDepartment of Radiation Oncology, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech RepublicDepartment of Comprehensive Cancer Care, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech RepublicAims: The aim of this investigator-initiated prospective randomized open-label single institutional trial is to evaluate the role of acupuncture in the treatment of acute skin and mucosal toxicity, xerostomia, and perception of taste, pain, and nausea related to curative and adjuvant (chemo)radiotherapy of head and neck cancer. This paper reports pilot data of the first 30 enrolled patients. Methods: Patients were randomized to undergo standard of care radiotherapy ± chemotherapy and support care defined by our institutional standard operating procedures alone or in the combination with acupuncture which was initiated with the first signs of any toxicity. Results: Fifteen patients were enrolled in both arms and all finished the treatment as planned.The median pain was significantly lower in the acupuncture arm (median 1.6 points vs. 2.5 points on a 10-item Likert scale; P=0.035) as well as duration of acute pain (median 31 days vs. 54 days; P=0.031). Patients with acupuncture had significantly shorter duration of acute skin (median 44 days vs. 109 days; P<0.001) and mucosal toxicity (median 34 days vs. 109 days; P<0.001) with no difference in grading of toxicity (median grade 1.6 vs. 1.5; P=0.701 and median grade 1.4 vs. 1.6; P=0.204 for skin and mucosa, respectively). No significant difference was found for other toxicity domains, with the exception of salivation toxicity which was significantly lower in acupuncture arm (median grade 1.3 vs. 1.7; P=0.048). Conclusion: In this interim analysis, acupuncture leads to lower pain andfaster disappearance of skin and mucosal toxicity after (chemo)radiotherapy of head and neck cancer. Description and validation of acupuncture using scientific approaches will further enhance acceptance of this method by both patients and health care providers. Trial Registration: Clinicaltrials.gov - NCT03751566https://biomed.papers.upol.cz/artkey/bio-202004-0014_acupuncture-in-the-treatment-of-acute-toxicity-during-and-after-head-and-neck-cancer-radiotherapy-interim-anal.phpacupuncturehead and neckcancerradiotherapytoxicity |
| spellingShingle | Radana Dymackova Tomas Kazda Marek Slavik Iveta Selingerova Pavel Slampa Ondrej Slama Acupuncture in the treatment of acute toxicity during and after head and neck cancer radiotherapy: Interim analysis of randomized prospective open-label trial Biomedical Papers acupuncture head and neck cancer radiotherapy toxicity |
| title | Acupuncture in the treatment of acute toxicity during and after head and neck cancer radiotherapy: Interim analysis of randomized prospective open-label trial |
| title_full | Acupuncture in the treatment of acute toxicity during and after head and neck cancer radiotherapy: Interim analysis of randomized prospective open-label trial |
| title_fullStr | Acupuncture in the treatment of acute toxicity during and after head and neck cancer radiotherapy: Interim analysis of randomized prospective open-label trial |
| title_full_unstemmed | Acupuncture in the treatment of acute toxicity during and after head and neck cancer radiotherapy: Interim analysis of randomized prospective open-label trial |
| title_short | Acupuncture in the treatment of acute toxicity during and after head and neck cancer radiotherapy: Interim analysis of randomized prospective open-label trial |
| title_sort | acupuncture in the treatment of acute toxicity during and after head and neck cancer radiotherapy interim analysis of randomized prospective open label trial |
| topic | acupuncture head and neck cancer radiotherapy toxicity |
| url | https://biomed.papers.upol.cz/artkey/bio-202004-0014_acupuncture-in-the-treatment-of-acute-toxicity-during-and-after-head-and-neck-cancer-radiotherapy-interim-anal.php |
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