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Melatonin Supplementation and Exercise Program in Breast Cancer Women

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06696378
Acronym
MEXBSO
Enrollment
120
Registered
2024-11-20
Start date
2025-01-15
Completion date
2026-05-01
Last updated
2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Trainning Progrmam, Female Breast Cancer, Older Adults

Keywords

Brear Cancer, Melatonin, quality of life, physical performance, health biomarkers, antioxidant capacity, anthropometrics parameters, Exerkins

Brief summary

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).

Interventions

DIETARY_SUPPLEMENTMelatonin 6 mg

wo capsules per day; Each capsule includes 3mg Melatonin Nutrifoods® Laboratories, Barcelona, Spain) by the Magistral Formulation Laboratory of a Pharmacy (Soria, Spain), following the rules of the Royal Spanish Pharmacopoeia (Ministry of Health, Government of Spain). Melatonin has a technical data sheet that guarantees its composition and purity (Reference No.: DIE-134).

OTHERPlacebo

Two capsules per day; Each capsule includes 100-mg maltodextrin capsules were used as a placebo to match the color and texture of the Melatonin tablets to ensure blinding.

Sponsors

Sanidad de Castilla y León
CollaboratorOTHER
Ministerio de Ciencia e Innovación, Spain
CollaboratorOTHER_GOV
Fundación General Universidad de Valladolid
CollaboratorOTHER
University of Valladolid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Double (Investigator, Participants)

Intervention model description

Parallel group placebo-controlled randomized clinical trial

Eligibility

Sex/Gender
FEMALE
Age
60 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Irisinfirst day of study and after 60 days of supplementation (end of study)Exerkin secreted primarily by skeletal muscle in response to exercise
Sestrin-2first 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.

Secondary

MeasureTime frameDescription
World Health Organization Quality of Life - BREF (WHOQOL-BREF)first day of study and after 60 days of supplementation (end of study)a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment
Creatine kinase (CK)first day of study and after 60 days of supplementation (end of study)CK is an enzyme expressed by various tissues and cell types; markers of muscle damage
Lactate dehydrogenase (LDH)first day of study and after 60 days of supplementation (end of study)LDH is a catalytic enzyme found in many tissues of the body;markers of muscle damage
Cortisolfirst day of study and after 60 days of supplementation (end of study)catabolic hormone released in response to stress
Testosteronefirst day of study and after 60 days of supplementation (end of study)anabolic hormone
BAPfirst day of study and after 60 days of supplementation (end of study)biological antioxidant potential (BAP) test to estimate antioxidant capacity by measuring the blood concentration of antioxidants
BMIfirst day of study and after 60 days of supplementation (end of study)Body Mass Index (BMI) anthropometric parameter which is the relationship between a person's body mass and their height
Fat Massfirst day of study and after 60 days of supplementation (end of study)Anthropometric parameter fat mass allows the estimation of overweight or obesity in humans
Short Physical Performance Battery (SPPB)first day of study and after 60 days of supplementation (end of study)Test evaluates three aspects of mobility measures balance, the second gait speed, and the third leg strength
Hand-grip strengthfirst day of study and after 60 days of supplementation (end of study)Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles
RPE-Borg 10first day of study and after 60 days of supplementation (end of study)RPE stands for Rating of Perceived Exertion.
Estradiolfirst day of study and after 60 days of supplementation (end of study)female sex hormone of the estrogen group.
d-ROMsfirst day of study and after 60 days of supplementation (end of study)diacron reactive oxygen metabolites (d-ROMs) pro-oxidant state of a biological sample, measures hydroperoxides

Countries

Spain

Contacts

Primary ContactDiego Fernández Lázaro, Professor; PhD
diego.fernandez.lazaro@uva.es+34 658073375
Backup ContactCesar Ignacio Fernández Lázaro, Professor; PhD
fernandezlazaro@usal.es+34 975129185

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026