{"title":"一项随机、对照、平行组试验，研究褪黑素对乳腺癌相关疲劳的长期影响及其辅助治疗。","authors":"Abdolazim Sedighi Pashaki, Fateme Sheida, Leila Moaddab Shoar, Tahereh Hashem, Danial Fazilat-Panah, Alireza Nemati Motehaver, Ali Ghanbari Motlagh, Safoora Nikzad, Mojtaba Bakhtiari, Leili Tapak, Zahir Keshtpour Amlashi, Seyed Alireza Javadinia, Zahra Keshtpour Amlashi","doi":"10.1177/15347354231168624","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Cancer related fatigue is a distressing condition and correlated with decrease in quality of life of patients with malignant conditions. In continuation of our previous research, we assessed long term anti-fatigue effects of melatonin in patients with the breast cancer.</p><p><strong>Material and methods: </strong>In this clinical trial, 92 breast cancer patients were randomly assigned to receive either melatonin (18 mg/day) or placebo from 1 week before the adjuvant treatments until 2 years after their completion. The levels of fatigue were assessed before and after intervention using Brief Fatigue Inventory (BFI) and were compared at a significance level of <i>P</i> ≤ .05.</p><p><strong>Results: </strong>The BFI scores were similar between the 2 groups at the baseline (placebo group: 5.56 ± 1.59 and melatonin group: 5.72 ± 1.68, <i>P</i> = .67). After the intervention, not only the mean fatigue score was significantly lower in melatonin group (2.93 ± 1.04 vs 1.99 ± 1.02, <i>P</i> < .001, <i>P</i> ≤ .05), but also a greater reduction in fatigue score in intervention group was evident over time (<i>P</i> ≤ .001).</p><p><strong>Conclusion: </strong>Long-term usage of melatonin even after completion of adjuvant therapies in women with breast cancer decreased the levels of fatigue associated with the malignant condition and its treatments.</p><p><strong>The trial registry name and url, and registration number: </strong>Iranian Registry of Clinical Trials, https://en.irct.ir/trial/62267, IRCT20180426039421N3.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":null,"pages":null},"PeriodicalIF":2.9000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c8/1a/10.1177_15347354231168624.PMC10161337.pdf","citationCount":"1","resultStr":"{\"title\":\"A Randomized, Controlled, Parallel-Group, Trial on the Long-term Effects of Melatonin on Fatigue Associated With Breast Cancer and Its Adjuvant Treatments.\",\"authors\":\"Abdolazim Sedighi Pashaki, Fateme Sheida, Leila Moaddab Shoar, Tahereh Hashem, Danial Fazilat-Panah, Alireza Nemati Motehaver, Ali Ghanbari Motlagh, Safoora Nikzad, Mojtaba Bakhtiari, Leili Tapak, Zahir Keshtpour Amlashi, Seyed Alireza Javadinia, Zahra Keshtpour Amlashi\",\"doi\":\"10.1177/15347354231168624\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>Cancer related fatigue is a distressing condition and correlated with decrease in quality of life of patients with malignant conditions. In continuation of our previous research, we assessed long term anti-fatigue effects of melatonin in patients with the breast cancer.</p><p><strong>Material and methods: </strong>In this clinical trial, 92 breast cancer patients were randomly assigned to receive either melatonin (18 mg/day) or placebo from 1 week before the adjuvant treatments until 2 years after their completion. The levels of fatigue were assessed before and after intervention using Brief Fatigue Inventory (BFI) and were compared at a significance level of <i>P</i> ≤ .05.</p><p><strong>Results: </strong>The BFI scores were similar between the 2 groups at the baseline (placebo group: 5.56 ± 1.59 and melatonin group: 5.72 ± 1.68, <i>P</i> = .67). After the intervention, not only the mean fatigue score was significantly lower in melatonin group (2.93 ± 1.04 vs 1.99 ± 1.02, <i>P</i> < .001, <i>P</i> ≤ .05), but also a greater reduction in fatigue score in intervention group was evident over time (<i>P</i> ≤ .001).</p><p><strong>Conclusion: </strong>Long-term usage of melatonin even after completion of adjuvant therapies in women with breast cancer decreased the levels of fatigue associated with the malignant condition and its treatments.</p><p><strong>The trial registry name and url, and registration number: </strong>Iranian Registry of Clinical Trials, https://en.irct.ir/trial/62267, IRCT20180426039421N3.</p>\",\"PeriodicalId\":13734,\"journal\":{\"name\":\"Integrative Cancer Therapies\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c8/1a/10.1177_15347354231168624.PMC10161337.pdf\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Integrative Cancer Therapies\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/15347354231168624\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"INTEGRATIVE & COMPLEMENTARY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Integrative Cancer Therapies","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/15347354231168624","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
A Randomized, Controlled, Parallel-Group, Trial on the Long-term Effects of Melatonin on Fatigue Associated With Breast Cancer and Its Adjuvant Treatments.
Objective: Cancer related fatigue is a distressing condition and correlated with decrease in quality of life of patients with malignant conditions. In continuation of our previous research, we assessed long term anti-fatigue effects of melatonin in patients with the breast cancer.
Material and methods: In this clinical trial, 92 breast cancer patients were randomly assigned to receive either melatonin (18 mg/day) or placebo from 1 week before the adjuvant treatments until 2 years after their completion. The levels of fatigue were assessed before and after intervention using Brief Fatigue Inventory (BFI) and were compared at a significance level of P ≤ .05.
Results: The BFI scores were similar between the 2 groups at the baseline (placebo group: 5.56 ± 1.59 and melatonin group: 5.72 ± 1.68, P = .67). After the intervention, not only the mean fatigue score was significantly lower in melatonin group (2.93 ± 1.04 vs 1.99 ± 1.02, P < .001, P ≤ .05), but also a greater reduction in fatigue score in intervention group was evident over time (P ≤ .001).
Conclusion: Long-term usage of melatonin even after completion of adjuvant therapies in women with breast cancer decreased the levels of fatigue associated with the malignant condition and its treatments.
The trial registry name and url, and registration number: Iranian Registry of Clinical Trials, https://en.irct.ir/trial/62267, IRCT20180426039421N3.
期刊介绍：
ICT is the first journal to spearhead and focus on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative medicine and traditional medicine therapies, and their responsible integration with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments. Contributors are leading oncologists, researchers, nurses, and health-care professionals.
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