A Randomized, Controlled, Parallel-Group, Trial on the Long-term Effects of Melatonin on Fatigue Associated With Breast Cancer and Its Adjuvant Treatments.

IF 2.9 3区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Integrative Cancer Therapies Pub Date : 2023-01-01 DOI:10.1177/15347354231168624

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

{"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":"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.","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}

引用次数: 1

Abstract

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.

Abstract Image

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

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。

目的:肿瘤相关性疲劳是一种令人痛苦的状态，与恶性肿瘤患者的生活质量下降有关。在之前研究的基础上，我们评估了褪黑素对乳腺癌患者的长期抗疲劳作用。材料和方法:在这项临床试验中，92名乳腺癌患者被随机分配接受褪黑激素(18mg /天)或安慰剂，从辅助治疗前1周开始，直到辅助治疗完成后2年。采用简短疲劳量表(Brief fatigue Inventory，简称BFI)评估干预前后患者的疲劳程度，比较P≤0.05的显著性水平。结果:两组患者在基线时BFI评分相近(安慰剂组:5.56±1.59，褪黑素组:5.72±1.68,P = 0.67)。干预后，褪黑素组的平均疲劳评分显著低于对照组(2.93±1.04 vs 1.99±1.02,P < 0.05)，且随时间推移，干预组的疲劳评分降低幅度更大(P < 0.001)。结论:即使在完成辅助治疗后，长期使用褪黑素也可以降低与恶性疾病及其治疗相关的疲劳水平。试验注册中心名称、url和注册号:伊朗临床试验注册中心，https://en.irct.ir/trial/62267, IRCT20180426039421N3。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Integrative Cancer Therapies 医学-全科医学与补充医学

CiteScore

4.80

自引率

3.40%

发文量

审稿时长

>12 weeks

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.