Status:
UNKNOWN
Treatment of Insomnia in Patients With Breast Cancer
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Breast Cancer
Insomnia
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
Insomnia, defined as difficulty falling asleep, staying asleep, or waking up too early at least three times a week for at least 3 months, (American Psychiatric Association 2013) is a common disorder b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06061666
Start Date
June 1 2023
End Date
June 30 2024
Last Update
September 29 2023
Active Locations (1)
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1
Dipartimento di Scienze di Laboratorio e Infettivologiche
Rome, Italy, 00168