跳至主要内容
临床试验/NCT06696378
NCT06696378招募中不适用

Impact of Melatonin Supplementation Plus Exercise Program in Women Who Have Suffered from Breast Cancer in the Province of Soria, Spain

University of Valladolid2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Irisin

研究概览

简要总结

Introduction: Breast cancer (BC) remains the leading cause of cancer in women with nearly 1.4 million new cases worldwide annually and 27.000 in Spain. Increasingly effective oncology therapies, however, have numerous adverse effects such as muscle degeneration, fatigue, decreased physical function and aerobic capacity, and deteriorating quality of life. In this sense, physical activity (PA) seems to be an interesting non-pharmacological strategy to alleviate these serious complications and with potential benefits for women with BC. Melatonin (N-acetyl-5 methoxytryptamine) is an indolic compound present with pleiotropic bioactions that regulates the circadian rhythm, antioxidant, anti-inflammatory, immunostimulant, cardioprotective, antidiabetic, antiobesity, neuroprotective, and antiaging actions. Furthermore, in recent years, many studies have described the key role of melatonin in preventing and developing cancer. The general anticarcinogenic mechanisms include epigenetic control, cell proliferation modulation, cell cycle regulation, apoptosis induction, and telomerase inhibition. Melatonin also exerts antiestrogenic activity, which is particularly significant in hormone-dependent tumors, regulating the expression and transactivation of the estrogen receptor, and modulating the enzymes involved in the local synthesis of estrogens. Despite all the mentioned properties, the use of melatonin in daily clinical practice is very limited, and additional studies are needed to better establish the role of this hormone in oncological clinical applications against different types of cancer.

Objective: To analyze the effect of supplementation with 4 g/day of melatonin for 10 weeks on muscle damage (CK and LDH), hormonal responses (estradiol, testosterone, cortisol and testosterone/cortisol ratio), antioxidant capacity (BAP and d-ROMs), Exerkins (Irisin and Sestrin 2), physical performance (handgrip strength, RPE and SPPB), anthropometry (body mass, BMI and fat mass) and WHOQOL-BREF (physical and psychological health, social relationships and environment) in women over 60 years of age who have suffered breast cancer and who follow a physical training program.

Methods: A total of 20 female volunteers between 60 and 73 years old (age: 65.5±4.52 years, BMI: 25.83±2.67 and body fat percentage: 33.73±5.54) who followed a physical activity adapted to their age and abilities are the members. of this study. The volunteers were divided into two groups: placebo (CG; n = 10) and supplemented with 5 g/day of melatonin (GI; n = 10). Differtent test were performed muscle damage (CK, and LDH), hormonal responses (estradiol, testosterone, cortisol, and testosterone/cortisol ratio), antioxidant capacity (BAP and d-ROMs), Exerkins (Irisin and Sestrin 2), physical performance (Hand-grip strength, RPE and SPPB), anthropometrics (Body mass, BMI and fat mass), and WHOQOL-BREF (physical and psychological health, social relationships and environment) were analyzed at the beginning (T1) and at the end of the 10 weeks of intervention (T2).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Double (Investigator, Participants)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Study participants were women with a history of ductal carcinoma in situ, lobular carcinoma in situ, or stage 1 to 3 breast cancer (5 years or more since diagnosis), not currently receiving chemotherapy or hormone therapy, postmenopausal, and Eastern Cooperative Oncology Group (ECOG) score ≤ 1

排除标准

  • women who had exercised regularly for at least 20 minutes once and at least twice a week in the 3 months before the study
  • Stage IV breast cancer or systemic recurrences
  • Known autoimmune diseases: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and multiple sclerosis.
  • Severe kidney disease
  • Use of adjuvant hormonal therapy, oral estrogen or progesterone replacement therapy, luteinizing hormone-releasing hormone agonists currently or within the past 60 days
  • 6-month ≥ post-chemotherapy
  • Concomitant use of sleeping pills every night at bedtime
  • Concomitant use of black cohosh, flaxseed, or soy in pill or supplement form
  • Functional limitation using the Barthel scale (less than 100 = maximum score) and the Lawton-Brody scale (less than 8 = maximum value).
  • Uncontrolled hypertension (>180/100 mm Hg).
  • Uncontrolled atrial or ventricular arrhythmias, dissecting aortic aneurysm, severe aortic stenosis, acute endocarditis/pericarditis
  • Acute thromboembolic disease.
  • Moderate/severe chronic obstructive pulmonary disease (COPD) with Bodex index C or D Recent bone fracture (last month).
  • Any other circumstance that your doctor considers prevents physical activity.
  • Neoadjuvant chemotherapy or radiotherapy
  • Concomitant use of beta-blockers
  • 6-month ≥ post-radiotherapy
  • Concomitant use of postmenopausal hormone replacement therapy
  • Use of any type of oral melatonin supplement in the past 30 days
  • Acute/chronic heart failure with NYHA (New York Heart Association) score >II
  • Uncontrolled orthostatic hypotension
  • Recent acute myocardial infarction (3 to 6 months) or unstable angina.
  • Acute/chronic respiratory failure.
  • Diabetes mellitus with acute decompensation or uncontrolled hypoglycemia
  • History of dementia (suspected by the GP environment and diagnosed).
  • Shift-work and night-work

结局指标

主要结局

Irisin

时间窗: first day of study and after 60 days of supplementation (end of study)

Exerkin secreted primarily by skeletal muscle in response to exercise

Sestrin-2

时间窗: first day of study and after 60 days of supplementation (end of study)

Exerkin a highly conserved stress-responsive protein, can be triggered by various noxious stimuli, such as hypoxia, DNA damage, oxidative stress, endoplasmic reticulum (ER) stress, and inflammation.

次要结局

  • BAP(first day of study and after 60 days of supplementation (end of study))
  • d-ROMs(first day of study and after 60 days of supplementation (end of study))
  • World Health Organization Quality of Life - BREF (WHOQOL-BREF)(first day of study and after 60 days of supplementation (end of study))
  • Creatine kinase (CK)(first day of study and after 60 days of supplementation (end of study))
  • Lactate dehydrogenase (LDH)(first day of study and after 60 days of supplementation (end of study))
  • Cortisol(first day of study and after 60 days of supplementation (end of study))
  • Testosterone(first day of study and after 60 days of supplementation (end of study))
  • Estradiol(first day of study and after 60 days of supplementation (end of study))
  • BMI(first day of study and after 60 days of supplementation (end of study))
  • Fat Mass(first day of study and after 60 days of supplementation (end of study))
  • Short Physical Performance Battery (SPPB)(first day of study and after 60 days of supplementation (end of study))
  • Hand-grip strength(first day of study and after 60 days of supplementation (end of study))
  • RPE-Borg 10(first day of study and after 60 days of supplementation (end of study))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diego Fernández Lázaro

Professor Doctor

University of Valladolid

研究点 (2)

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