Efficacy of thunder-fire moxibustion for cancer-related fatigue in breast cancer survivors: study protocol for a randomized controlled trial
BackgroundCancer-related fatigue (CRF) is one of the most prevalent and debilitating symptoms experienced by breast cancer survivors, often associated with dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis. In China, moxibustion is widely used as a therapeutic approach for managing fati...
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Frontiers Media S.A.
2025-03-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2025.1496741/full |
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| author | Huakang Li Huakang Li Zhonglin Zhang Qiang Li Yuyang Jin Yunjing Jia Pengxuan Gu Qi Xiao Lingna Jin Ziliang Wu Bing Lin Shanshan Wei Jinyi Lang |
| author_facet | Huakang Li Huakang Li Zhonglin Zhang Qiang Li Yuyang Jin Yunjing Jia Pengxuan Gu Qi Xiao Lingna Jin Ziliang Wu Bing Lin Shanshan Wei Jinyi Lang |
| author_sort | Huakang Li |
| collection | DOAJ |
| description | BackgroundCancer-related fatigue (CRF) is one of the most prevalent and debilitating symptoms experienced by breast cancer survivors, often associated with dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis. In China, moxibustion is widely used as a therapeutic approach for managing fatigue. Thunder-fire moxibustion (TFM), a novel technique with high thermal radiation and strong penetrative properties, may provide benefits for CRF. This study aims to assess the efficacy, safety, and underlying mechanisms of TFM in the treatment of CRF among breast cancer survivors.MethodsThis prospective, single-center, open-label, randomized controlled trial will recruit 70 breast cancer survivors diagnosed with CRF. Participants will be randomly assigned in a 1:1 ratio to either a waitlist control group or a TFM intervention group. All participants will receive standard care during the 30-day treatment period. Those in the TFM group will additionally undergo TFM treatment every other day, totaling 15 sessions. The primary outcome measure is the change in total fatigue score, assessed using the Piper Fatigue Scale, from baseline to the end of treatment. Additionally, this study will investigate the underlying mechanisms of TFM by evaluating changes in HPA axis-related hormone levels, inflammatory markers, gut microbiota composition, and conducting metabolomic analyses of fecal and blood samples.DiscussionThis study takes a multidisciplinary approach to comprehensively explore how TFM modulates biological systems involved in CRF, aiming to generate robust evidence. If successful, this study will provide high-quality, evidence-based reference points for the treatment of CRF in breast cancer survivors and inform future research in integrative medicine.Trial registrationThe study has been registered with the International Traditional Medicine Clinical Trial Registry (http://itmctr.ccebtcm.org.cn, ITMCTR2024000406). |
| format | Article |
| id | doaj-art-b7297d773edf48ccbb1af18a764be062 |
| institution | OA Journals |
| issn | 2234-943X |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj-art-b7297d773edf48ccbb1af18a764be0622025-08-20T01:58:04ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2025-03-011510.3389/fonc.2025.14967411496741Efficacy of thunder-fire moxibustion for cancer-related fatigue in breast cancer survivors: study protocol for a randomized controlled trialHuakang Li0Huakang Li1Zhonglin Zhang2Qiang Li3Yuyang Jin4Yunjing Jia5Pengxuan Gu6Qi Xiao7Lingna Jin8Ziliang Wu9Bing Lin10Shanshan Wei11Jinyi Lang12School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, ChinaDepartment of Oncology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, ChinaDepartment of Radiation Oncology, Radiation Oncology Key Laboratory of Sichuan Province, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, Chengdu, Sichuan, ChinaDepartment of Oncology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, ChinaInstitute of Sports Medicine and Health, Chengdu Sport University, Chengdu, Sichuan, ChinaSchool of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, ChinaSchool of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, ChinaHealth Management Center, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, ChinaHealth Management Center, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, ChinaHealth Management Center, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, ChinaHealth Management Center, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, ChinaDepartment of Radiation Oncology, Radiation Oncology Key Laboratory of Sichuan Province, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, Chengdu, Sichuan, ChinaDepartment of Radiation Oncology, Radiation Oncology Key Laboratory of Sichuan Province, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, Chengdu, Sichuan, ChinaBackgroundCancer-related fatigue (CRF) is one of the most prevalent and debilitating symptoms experienced by breast cancer survivors, often associated with dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis. In China, moxibustion is widely used as a therapeutic approach for managing fatigue. Thunder-fire moxibustion (TFM), a novel technique with high thermal radiation and strong penetrative properties, may provide benefits for CRF. This study aims to assess the efficacy, safety, and underlying mechanisms of TFM in the treatment of CRF among breast cancer survivors.MethodsThis prospective, single-center, open-label, randomized controlled trial will recruit 70 breast cancer survivors diagnosed with CRF. Participants will be randomly assigned in a 1:1 ratio to either a waitlist control group or a TFM intervention group. All participants will receive standard care during the 30-day treatment period. Those in the TFM group will additionally undergo TFM treatment every other day, totaling 15 sessions. The primary outcome measure is the change in total fatigue score, assessed using the Piper Fatigue Scale, from baseline to the end of treatment. Additionally, this study will investigate the underlying mechanisms of TFM by evaluating changes in HPA axis-related hormone levels, inflammatory markers, gut microbiota composition, and conducting metabolomic analyses of fecal and blood samples.DiscussionThis study takes a multidisciplinary approach to comprehensively explore how TFM modulates biological systems involved in CRF, aiming to generate robust evidence. If successful, this study will provide high-quality, evidence-based reference points for the treatment of CRF in breast cancer survivors and inform future research in integrative medicine.Trial registrationThe study has been registered with the International Traditional Medicine Clinical Trial Registry (http://itmctr.ccebtcm.org.cn, ITMCTR2024000406).https://www.frontiersin.org/articles/10.3389/fonc.2025.1496741/fullmoxibustioncancer-related fatiguebreast cancerrandomized controlled trialclinical trial protocol |
| spellingShingle | Huakang Li Huakang Li Zhonglin Zhang Qiang Li Yuyang Jin Yunjing Jia Pengxuan Gu Qi Xiao Lingna Jin Ziliang Wu Bing Lin Shanshan Wei Jinyi Lang Efficacy of thunder-fire moxibustion for cancer-related fatigue in breast cancer survivors: study protocol for a randomized controlled trial Frontiers in Oncology moxibustion cancer-related fatigue breast cancer randomized controlled trial clinical trial protocol |
| title | Efficacy of thunder-fire moxibustion for cancer-related fatigue in breast cancer survivors: study protocol for a randomized controlled trial |
| title_full | Efficacy of thunder-fire moxibustion for cancer-related fatigue in breast cancer survivors: study protocol for a randomized controlled trial |
| title_fullStr | Efficacy of thunder-fire moxibustion for cancer-related fatigue in breast cancer survivors: study protocol for a randomized controlled trial |
| title_full_unstemmed | Efficacy of thunder-fire moxibustion for cancer-related fatigue in breast cancer survivors: study protocol for a randomized controlled trial |
| title_short | Efficacy of thunder-fire moxibustion for cancer-related fatigue in breast cancer survivors: study protocol for a randomized controlled trial |
| title_sort | efficacy of thunder fire moxibustion for cancer related fatigue in breast cancer survivors study protocol for a randomized controlled trial |
| topic | moxibustion cancer-related fatigue breast cancer randomized controlled trial clinical trial protocol |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2025.1496741/full |
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