Treatment of Insomnia in Patients With Breast Cancer

NCT06061666 | Unknown

• 1 other identifier: 5175
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 both in the general population and in cancer patients, but it is particularly common in breast cancer patients. (Davidson JR, 2002) (Savard J, 2001). Unfortunately, this issue is often not recognized and is not adequately addressed in common clinical practice (Zhou ES, 2017). Emotional distress, stress after surgery, and side effects of cancer treatments, particularly those related to hormone therapy, all contribute to the onset of insomnia, which, in turn, can contribute to a poor quality of life, to greater fatigue in carrying out daily life activities, to worsening physical and emotional discomfort (Kyle SD, 2010) (Bolge SC, 2009) (Sarsour K, 2011). To date, insomnia in common clinical practice is an often overlooked problem. Patients report that healthcare providers rarely pay attention to sleep disorders and even if they are evaluated, treatment recommendations tend to focus primarily on prescribing medications (Siefert ML, 2014). Gemmotherapy is a young branch of phytotherapy developed in the second half of the last century. This branch bases its principles on the therapeutic potential of the meristematic tissues of plants and uses products called glycerine macerates (GM) obtained according to the method of cold maceration of meristematic tissues in water, alcohol and glycerol created by Dr. Pol Henry in the last century or according to the Pharmacopoeias. The use of concentrated GM (C-GM) has spread (Andrianne, 2008 and 2012). These C-MGs are approximately 10 times more concentrated than traditional GMs, and are therefore traditionally used at lower doses (adults: approximately 5-15 gtt/day) than those used for diluted extracts (adults: up to 1 gtt/kg/day ). Tilia tomentosa, whose fresh buds are used, is traditionally indicated in all cases of insomnia in adults and children. Its action is carried out by inducing sleep and increasing its duration. In phytotherapy it is recommended in neuroses but also as an antispasmodic, in heart palpitations and in spasmophilia. No type of acute or chronic toxicity is known for this C-GM. In the proposed study we want to evaluate the action of C-GM from Tilia tomentosa, extracted according to the Pharmacopoeias, for the treatment of insomnia in patients with breast cancer on hormone therapy.

Conditions

Breast Cancer; Insomnia

Outcome Measures

Primary Outcomes (1)

• Tilia tomentosa glyceric macerate effectiveness against insomnia of brest cancer patients

  evaluate the effect of the Tilia tomentosa C-GM food supplement in contributing to the physiological restoration of the quality and duration of sleep in patients undergoing breast cancer surgery and hormone therapy.

  T1: 15 days, and T2: 75 days

Study Arms (2)

Treated group

EXPERIMENTAL

Group treated with MG-C of Tilia tomentosa

Other: Tilia tomentosa Concentrated - Glycerine macerate (C-GM) vs Placebo (1 gtt/10 kg/day before bedtime for 15 days)

Placebo Group

PLACEBO COMPARATOR

Group treated with placebo

Other: Tilia tomentosa Concentrated - Glycerine macerate (C-GM) vs Placebo (1 gtt/10 kg/day before bedtime for 15 days)

Interventions

Tilia tomentosa Concentrated - Glycerine macerate (C-GM) vs Placebo (1 gtt/10 kg/day before bedtime for 15 days) OTHER

Self-administration of the food supplement or placebo (1 gtt/10 kg/day before bedtime for 15 days)

Placebo Group; Treated group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Dipartimento di Scienze di Laboratorio e Infettivologiche

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Di Vito

CONTACT

3925476062; maura.divito@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: September 29, 2023
• Study Start: June 1, 2023
• Primary Completion: January 20, 2024
• Study Completion: June 30, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

IT (1)