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NCT Number: NCT06696378

Melatonin Supplementation and Exercise Program in Breast Cancer Women

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).

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Key information

Conditions

Female Breast Cancer Exercise Trainning Progrmam Older Adults

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences, University of Valladolid Soria Campus

Soria, 42004, Spain

Location status: Recruiting

Location contact

Diego Fernández Lázaro, Vice Dean

CONTACT

[email protected]

658073375

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin 6 mg

Dietary Supplement

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).

Placebo

Other

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.

Primary outcomes

  1. Irisin

    Time frame: first day of study and after 60 days of supplementation (end of study)

    Exerkin secreted primarily by skeletal muscle in response to exercise

  2. Sestrin-2

    Time frame: 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.

Secondary outcomes

  1. BAP

    Time frame: first 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

  2. d-ROMs

    Time frame: first 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

  3. World Health Organization Quality of Life - BREF (WHOQOL-BREF)

    Time frame: 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

  4. Creatine kinase (CK)

    Time frame: 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

  5. Lactate dehydrogenase (LDH)

    Time frame: 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

  6. Cortisol

    Time frame: first day of study and after 60 days of supplementation (end of study)

    catabolic hormone released in response to stress

  7. Testosterone

    Time frame: first day of study and after 60 days of supplementation (end of study)

    anabolic hormone

  8. Estradiol

    Time frame: first day of study and after 60 days of supplementation (end of study)

    female sex hormone of the estrogen group.

  9. BMI

    Time frame: first 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

  10. Fat Mass

    Time frame: first 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

  11. Short Physical Performance Battery (SPPB)

    Time frame: 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

  12. Hand-grip strength

    Time frame: first 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

  13. RPE-Borg 10

    Time frame: first day of study and after 60 days of supplementation (end of study)

    RPE stands for Rating of Perceived Exertion.

Study contacts

Contact information is provided by the study sponsor or research team.

Cesar Ignacio Fernández Lázaro, Professor; PhD

CONTACT

[email protected]

+34 975129185

Diego Fernández Lázaro, Professor; PhD

CONTACT

[email protected]

+34 658073375

Sponsors and collaborators

Lead sponsor

University of Valladolid

Other

Collaborators

  • Fundación General Universidad de Valladolid
  • Ministerio de Ciencia e Innovación, Spain
  • Sanidad de Castilla y León

Registry information

Official study title

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

Acronym: MEXBSO

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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