Chinese Herbal Medicine for Concurrent Chemoradiation-Induced Adverse Events in Head and Neck Cancer Patients: A Prospective Feasibility Study
The objective of this study was to evaluate the efficacy of the traditional Chinese herbal medicine formula, San-Zhong-Kui-Jian-Tang (SZKJT), on patients with head and neck cancer who underwent concurrent chemoradiotherapy (CCRT). We performed a single-center, open-label, prospective feasibility stu...
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SAGE Publishing
2025-03-01
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| Series: | Integrative Cancer Therapies |
| Online Access: | https://doi.org/10.1177/15347354251326946 |
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| author | Hsuan-Ting Tang MD Shi-Chen Ou MD, PhD Chien-Lun Chu MSc Ai-Lin Lee MD Hung-Jen Lin MD, PhD Ying-Chun Lin MD Yao-Ching Wang MD Shih-Neng Yang MD, PhD Ming-Yu Lien MD, PhD |
| author_facet | Hsuan-Ting Tang MD Shi-Chen Ou MD, PhD Chien-Lun Chu MSc Ai-Lin Lee MD Hung-Jen Lin MD, PhD Ying-Chun Lin MD Yao-Ching Wang MD Shih-Neng Yang MD, PhD Ming-Yu Lien MD, PhD |
| author_sort | Hsuan-Ting Tang MD |
| collection | DOAJ |
| description | The objective of this study was to evaluate the efficacy of the traditional Chinese herbal medicine formula, San-Zhong-Kui-Jian-Tang (SZKJT), on patients with head and neck cancer who underwent concurrent chemoradiotherapy (CCRT). We performed a single-center, open-label, prospective feasibility study from 2018 to 2020. A total of 27 head and neck cancer patients who received CCRT were recruited for the study. SZKJT was given to patients simultaneously with CCRT for 9 weeks. The primary endpoint was the feasibility and completion rate of CCRT, while the secondary endpoint was occurrence of adverse effects. The quality of life (QoL) and traditional Chinese medicine body constitutions were measured by the QLQ-C30 and the Body Constitution Questionnaire (BCQ), respectively. There were 6 dropouts from the study due to complications, while 21 participants completed the trial. Among those 21 participants, 16 completed the CCRT treatment course, yielding a completion rate of 76.2%. The side effects observed during the CCRT and SZKJT trial included dermatitis in 4.8% (Grade 0), 57.1% (Grade 1), and 38.1% (Grade 2), and oral mucositis in 62.0% (Grade 1), 19.0% (Grade 2), and 19.0% (Grade 3) of participants. A comparison of the pre- and post-treatment QLQ-C30 scores revealed that QoL was unaffected ( P = .506). However, the BCQ results showed significant increases in the Yin-Xu, Yang-Xu, and stasis constitutions ( P < .001). No serious adverse events were observed due to SZKJT. Preliminary results indicated that additional SZKJT with CCRT was feasible, while noting a high completion CCRT rate (76.2%) among the SZKJT-treated patients. Our study reveals that SZKJT can effectively reduce the severity of dermatitis and oral mucositis associated with CCRT. Larger randomized controlled trials are required to further assess the efficacy and safety of SZKJT. The trial registration number is NCT05590650 on ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT05590650 |
| format | Article |
| id | doaj-art-b57c58bf291d4fb993cd7a3272d4787c |
| institution | DOAJ |
| issn | 1552-695X |
| language | English |
| publishDate | 2025-03-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Integrative Cancer Therapies |
| spelling | doaj-art-b57c58bf291d4fb993cd7a3272d4787c2025-08-20T02:41:37ZengSAGE PublishingIntegrative Cancer Therapies1552-695X2025-03-012410.1177/15347354251326946Chinese Herbal Medicine for Concurrent Chemoradiation-Induced Adverse Events in Head and Neck Cancer Patients: A Prospective Feasibility StudyHsuan-Ting Tang MD0Shi-Chen Ou MD, PhD1Chien-Lun Chu MSc2Ai-Lin Lee MD3Hung-Jen Lin MD, PhD4Ying-Chun Lin MD5Yao-Ching Wang MD6Shih-Neng Yang MD, PhD7Ming-Yu Lien MD, PhD8China Medical University Hospital, Taichung, TaiwanChina Medical University, Taichung, TaiwanChina Medical University Hospital, Taichung, TaiwanChina Medical University Hospital, Taichung, TaiwanChina Medical University, Taichung, TaiwanChina Medical University Hospital, Taichung, TaiwanChina Medical University Hospital, Taichung, TaiwanChina Medical University, Taichung, TaiwanChina Medical University, Taichung, TaiwanThe objective of this study was to evaluate the efficacy of the traditional Chinese herbal medicine formula, San-Zhong-Kui-Jian-Tang (SZKJT), on patients with head and neck cancer who underwent concurrent chemoradiotherapy (CCRT). We performed a single-center, open-label, prospective feasibility study from 2018 to 2020. A total of 27 head and neck cancer patients who received CCRT were recruited for the study. SZKJT was given to patients simultaneously with CCRT for 9 weeks. The primary endpoint was the feasibility and completion rate of CCRT, while the secondary endpoint was occurrence of adverse effects. The quality of life (QoL) and traditional Chinese medicine body constitutions were measured by the QLQ-C30 and the Body Constitution Questionnaire (BCQ), respectively. There were 6 dropouts from the study due to complications, while 21 participants completed the trial. Among those 21 participants, 16 completed the CCRT treatment course, yielding a completion rate of 76.2%. The side effects observed during the CCRT and SZKJT trial included dermatitis in 4.8% (Grade 0), 57.1% (Grade 1), and 38.1% (Grade 2), and oral mucositis in 62.0% (Grade 1), 19.0% (Grade 2), and 19.0% (Grade 3) of participants. A comparison of the pre- and post-treatment QLQ-C30 scores revealed that QoL was unaffected ( P = .506). However, the BCQ results showed significant increases in the Yin-Xu, Yang-Xu, and stasis constitutions ( P < .001). No serious adverse events were observed due to SZKJT. Preliminary results indicated that additional SZKJT with CCRT was feasible, while noting a high completion CCRT rate (76.2%) among the SZKJT-treated patients. Our study reveals that SZKJT can effectively reduce the severity of dermatitis and oral mucositis associated with CCRT. Larger randomized controlled trials are required to further assess the efficacy and safety of SZKJT. The trial registration number is NCT05590650 on ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT05590650https://doi.org/10.1177/15347354251326946 |
| spellingShingle | Hsuan-Ting Tang MD Shi-Chen Ou MD, PhD Chien-Lun Chu MSc Ai-Lin Lee MD Hung-Jen Lin MD, PhD Ying-Chun Lin MD Yao-Ching Wang MD Shih-Neng Yang MD, PhD Ming-Yu Lien MD, PhD Chinese Herbal Medicine for Concurrent Chemoradiation-Induced Adverse Events in Head and Neck Cancer Patients: A Prospective Feasibility Study Integrative Cancer Therapies |
| title | Chinese Herbal Medicine for Concurrent Chemoradiation-Induced Adverse Events in Head and Neck Cancer Patients: A Prospective Feasibility Study |
| title_full | Chinese Herbal Medicine for Concurrent Chemoradiation-Induced Adverse Events in Head and Neck Cancer Patients: A Prospective Feasibility Study |
| title_fullStr | Chinese Herbal Medicine for Concurrent Chemoradiation-Induced Adverse Events in Head and Neck Cancer Patients: A Prospective Feasibility Study |
| title_full_unstemmed | Chinese Herbal Medicine for Concurrent Chemoradiation-Induced Adverse Events in Head and Neck Cancer Patients: A Prospective Feasibility Study |
| title_short | Chinese Herbal Medicine for Concurrent Chemoradiation-Induced Adverse Events in Head and Neck Cancer Patients: A Prospective Feasibility Study |
| title_sort | chinese herbal medicine for concurrent chemoradiation induced adverse events in head and neck cancer patients a prospective feasibility study |
| url | https://doi.org/10.1177/15347354251326946 |
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