Melatonin and exercise program for women with breast cancer
Impact of Melatonin Supplementation Plus Exercise Program in Women Who Have Suffered from Breast Cancer in the Province of Soria, Spain
This study is testing if taking melatonin along with an exercise program can help improve the quality of life for postmenopausal women who have had breast cancer by reducing fatigue and boosting physical function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | Female |
| Sponsor | University of Valladolid Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Soria, Soria) |
| Trial ID | NCT06696378 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of melatonin supplementation combined with an exercise program on women who have a history of breast cancer. The aim is to alleviate adverse effects from cancer treatments, such as fatigue and decreased physical function, by enhancing quality of life through non-pharmacological strategies. Participants will receive either melatonin or a placebo while engaging in a structured exercise regimen. The study focuses on postmenopausal women who are not currently undergoing chemotherapy or hormone therapy.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women with a history of early-stage breast cancer who are not currently receiving chemotherapy or hormone therapy.
Not a fit: Patients with advanced-stage breast cancer or those currently undergoing chemotherapy or hormone therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the quality of life and physical performance in women recovering from breast cancer.
How similar studies have performed: Previous studies have shown promising results with similar interventions combining exercise and melatonin in improving outcomes for cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Soria, Soria
- Faculty of Health Sciences, University of Valladolid Soria Campus — Soria, Soria, Spain (Recruiting)
Study contacts
- Study coordinator: Diego Fernández Lázaro, Professor; PhD
- Email: diego.fernandez.lazaro@uva.es
- Phone: +34 658073375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.