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Treatment of Insomnia in Patients With Breast Cancer

Primary Purpose

Breast Cancer, Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Tilia tomentosa Concentrated - Glycerine macerate (C-GM) vs Placebo (1 gtt/10 kg/day before bedtime for 15 days)
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

Treated group

Placebo Group

Arm Description

Group treated with MG-C of Tilia tomentosa

Group treated with placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2023
Last Updated
September 25, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT06061666
Brief Title
Treatment of Insomnia in Patients With Breast Cancer
Official Title
TILIA for inSomnia During HOrmonal Therapy in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
January 20, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treated group
Arm Type
Experimental
Arm Description
Group treated with MG-C of Tilia tomentosa
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Group treated with placebo
Intervention Type
Other
Intervention Name(s)
Tilia tomentosa Concentrated - Glycerine macerate (C-GM) vs Placebo (1 gtt/10 kg/day before bedtime for 15 days)
Intervention Description
Self-administration of the food supplement or placebo (1 gtt/10 kg/day before bedtime for 15 days)
Primary Outcome Measure Information:
Title
Tilia tomentosa glyceric macerate effectiveness against insomnia of brest cancer patients
Description
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.
Time Frame
T1: 15 days, and T2: 75 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Di Vito
Phone
3925476062
Email
maura.divito@unicatt.it
Facility Information:
Facility Name
Dipartimento di Scienze di Laboratorio e Infettivologiche
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanguinetti
Phone
+390630159448
Email
maurizio.sanguinetti@policlinicogemelli.it

12. IPD Sharing Statement

Learn more about this trial

Treatment of Insomnia in Patients With Breast Cancer

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