Treating insomnia in breast cancer patients
TILIA for inSomnia During HOrmonal Therapy in Breast Cancer Survivors
NA · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06061666
This study is testing if a plant-based treatment can help breast cancer patients sleep better compared to a placebo.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome) |
| Trial ID | NCT06061666 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to address insomnia, a common issue among breast cancer patients, by comparing the effects of Tilia tomentosa Concentrated - Glycerine macerate against a placebo. Insomnia can significantly impact the quality of life for these patients, often exacerbated by emotional distress and side effects from treatments. The study will involve patients who are undergoing surgery for breast tumors and hormone therapy, focusing on those with a score greater than 5 on the Pittsburgh Sleep Quality Index. Participants will receive the intervention for 15 days before bedtime to assess improvements in sleep quality.
Who should consider this trial
Good fit: Ideal candidates are breast cancer patients aged 18 to 65 who are undergoing surgery and hormone therapy and have reported poor sleep quality.
Not a fit: Patients over 65, those undergoing chemotherapy or radiotherapy, and individuals with serious concomitant diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and overall well-being for breast cancer patients suffering from insomnia.
How similar studies have performed: While insomnia is a common issue in cancer care, this specific approach using Tilia tomentosa is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rome
- Dipartimento di Scienze di Laboratorio e Infettivologiche — Rome, Italy (RECRUITING)
Study contacts
- Study coordinator: Di Vito
- Email: maura.divito@unicatt.it
- Phone: 3925476062
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.
Conditions: Breast Cancer, Insomnia