Treatment of Insomnia in Patients With Breast Cancer
Breast Cancer, Insomnia
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: Patients capable of giving informed consent Patients undergoing surgery to remove breast tumors and undergoing hormone therapy (any stage) Patients who present a score > 5 on the "Pittsburgh Sleep Quality Index (PSQI)" questionnaire on sleep quality Patients aged between 18 and 65 years Exclusion Criteria: Children under 18 and people over 65 Pregnant or breastfeeding women Patients with breast cancer undergoing chemotherapy and/or radiotherapy Serious concomitant diseases (other neoplasms, liver failure, renal failure, and hyperthyroidism, ulcerative colitis, Crohn's disease) Patients being treated with antibiotics in the month preceding screening Patients being treated with drugs that alter the sleep-wake rhythm (anxiolytics, hypnotics, non-benzodiazepine hypnotics, major sedatives, antipsychotics, antiepileptics, opiates) Known hypersensitivity to Tilia tomentosa
Sites / Locations
- Dipartimento di Scienze di Laboratorio e InfettivologicheRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Treated group
Placebo Group
Group treated with MG-C of Tilia tomentosa
Group treated with placebo