Breast CancerNCT06061666
Treatment of Insomnia in Patients With Breast Cancer
A study of Breast Cancer and Insomnia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Insomnia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Dipartimento di Scienze di Laboratorio e Infettivologiche
Rome, 00168
Sanguinetti, +390630159448, maurizio.sanguinetti@policlinicogemelli.it
About this study
Official title: TILIA for inSomnia During HOrmonal Therapy in Breast Cancer Survivors
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).
Read more
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
- Being tested
- Tilia tomentosa Concentrated - Glycerine macerate (C-GM) vs Placebo (1 gtt/10 kg/day before bedtime for 15 days)
- Medical subject headings
- Breast Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Treated group | Experimental | Group treated with MG-C of Tilia tomentosa Receives: 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 Receives: Other: Tilia tomentosa Concentrated - Glycerine macerate (C-GM) vs Placebo (1 gtt/10 kg/day before bedtime for 15 days) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T1: 15 days, and T2: 75 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Jun 2023
- Primary completion20 Jan 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061666
- Sponsor's protocol ID
- 5175
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TILIA for inSomnia During HOrmonal Therapy in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT06061666
- Acronym / sponsor ID
- 5175
- Conditions
- Breast Cancer, Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated group | Experimental | Other: Tilia tomentosa Concentrated - Glycerine macerate (C-GM) vs Placebo (1 gtt/10 kg/day before bedtime for 15 days)Group treated with MG-C of Tilia tomentosa |
| Placebo Group | Placebo comparator | Other: Tilia tomentosa Concentrated - Glycerine macerate (C-GM) vs Placebo (1 gtt/10 kg/day before bedtime for 15 days)Group treated with placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tilia tomentosa Concentrated - Glycerine macerate (C-GM) vs Placebo (1 gtt/10 kg/day before bedtime for 15 days)Self-administration of the food supplement or placebo (1 gtt/10 kg/day before bedtime for 15 days) | Other | Placebo Group, Treated group |
Primary outcome
Tilia tomentosa glyceric macerate effectiveness against insomnia of brest cancer patients
Time frame: T1: 15 days, and T2: 75 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Breast Cancer and Insomnia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Di Vito (3925476062, maura.divito@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tilia tomentosa glyceric macerate effectiveness against insomnia of brest cancer patients (time frame: T1: 15 days, and T2: 75 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.