Breast Cancer FemalePhase 3NCT03997188
Zinc-L-Carnosine Prevents Dysphagia in Breast Cancer Patients Undergoing Adjuvant Radiotherapy
A Phase 3 study testing Hepilor in people with Breast Cancer Female and Dysphagia, run by Cynthia Aristei at 1 site in Italy.
Trial summary
Irradiation of level III and IV draining nodes in breast cancer patients is often associated with dysphagia, requiring treatment with FANS and/or steroids. The present randomized phase III trial determined whether Zinc-L-Carnosine ( Hepilor), prevents or delays the onset of dysphagia in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Dysphagia, Adjuvant Radiotherapy
- What is being tested?
- Hepilor
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 21 Dec 2015to 20 Dec 2017
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years
- breast cancer patients who were candidates for post-operative RT by means of HeT to the breast /chest wall and SC/IC nodes (III-IV levels).
Who cannot join
- pregnancy or lactation
- known or suspected hypersensitivity or allergy to ZLC or to any of the excipients in its oral solution.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study for the Evaluation of the Impact of HEPILOR on the Possible Delay in the Development of Dysphagia in Breast Cancer Patients Undergoing Adjuvant Radiotherapy on the Breast/Thoracic Wall and Lymph Node Drainage.
Irradiation of level III and IV draining nodes in breast cancer patients is often associated with dysphagia, requiring treatment with FANS and/or steroids. The present randomized phase III trial determined whether Zinc-L-Carnosine ( Hepilor), prevents or delays the onset of dysphagia in these patients.
Read the detailed description
. This is a randomized phase III prospective placebo-controlled trial with patients recruited from one single university teaching hospital. Inclusion criteria were: age ≥18 years, breast cancer patients who were candidates for post-operative RT by means of HeT to the breast /chest wall and SC/IC nodes (III-IV levels).Exclusion criteria were: pregnancy or lactation, known or suspected hypersensitivity or allergy to ZLC or to any of the excipients in its oral solution.
All patients were randomized by a pre-determined computer code to two groups.
- HEPILOR arm: patients received ZLC solution
- Placebo arm: patients received a placebo solution Toxicity was assessed weekly in all patients immediately before or after the RT session. Acute toxicity was defined as occurring during RT or in 30 days after it ended and assessed using the Common Terminology Criteria for Adverse Events (CTCAE 4.0 scale). Dysphagia was assessed weekly by means of EAT 10, a self-administered questionnaire
- Conditions
- Breast Cancer Female, Dysphagia, Adjuvant Radiotherapy
- Being tested
- Hepilor
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepilorDevice
Also called Placebo
ZLC oral suspension and placebo were both started on Day 1 of RT-HeT and ended when RT was completed or at the onset of dysphagia.
| Study group | Role | What they receive |
|---|---|---|
| Hepilor arm | Experimental | patients received ZLC solution. The prescribed dose was 10 ml, in the morning and evening, between meals. Receives: Device: Hepilor |
| Placebo arm | Placebo comparator | Patients received a placebo solution. The prescribed dose was 10 ml, in the morning and evening, between meals Receives: Device: Hepilor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zinc-L-Carnosine prevents dysphagia in breast cancer patients undergoing adjuvant radiotherapy: clinical outcome assessed by Eating Assessment Tool (EAT-10) questionaire
The Primary end-point was no dysphagia. The study aim is to assess whether the medical device is able to avoid or delay the onset of dysphagia. The patients were evaluated before the start of radiotherapy and weekly to identify the possible appearance of dysphagia. Dysphagia was assessed weekly by means of self-assessment EAT10 questionnaire that is a tool used to assess objectively the presence of dysphagia, in details (0 = No problem 4 = Severe problem): 1. My swallowing problem has caused me to lose weight; 2. My swallowing problem interferes with my ability to go out for meals; 3. Swallowing liquids takes extra effort; 4. Swallowing solids takes extra effort; 5. Swallowing pills takes extra effort; 6. Swallowing is painful; 7. The pleasure of eating is affected by my wallowing; 8. When I swallow food sticks in my throat; 9. I cough when I eat; 10. Swallowing is stressful.
Measured: once a week during the radiotherapy and once at first month of follow-up
Degree of dysphagia
The degree of dysphagia was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) 4.0 scale.
When the patient showed a score of the questionnaire greater than 3 the target was reached dysphagia was present and this was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Dysphagia =Grade 1: Symptomatic, able to eat regular diet. Grade 2: Symptomatic and altered eating/swallowing. Grade 3: Severely altered eating/swallowing; tube feeding or TPN or hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death.
Measured: only in the presence of dysphagia:once a week during the radiotherapy and once at first month of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start21 Dec 2015
- Primary completion14 Nov 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- note Study Phase\* A medical device is a substance; whose purpose is comparable to the drug ( therapy, prevention, diagnosis, restoration of functions), but it is different from the drug because the drug acts with pharmacological, metabolic and immunological means, while the medical device acts through a mechanical action. Hepilor is a medical device in the form of a syrup with specific properties to protect and repair the gastro-intestinal mucosa. The functional substances of the medical device (Zinc-L-Carnosine and Sodium Alginate) thanks to their mucoadhesive properties act as a physical barrier protecting the damaged areas. In consideration of this we have designed a randomized phase III to to determine whether ZLC prevented or delayed esophagitis in breast cancer patients undergoing HeT to SC/IC lymph nodes and residual breast or chest wall.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynthia Aristei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cynthia Aristei, University Of Perugia
- Investigators
- Cynthia Aristei, MD, Principal investigator, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997188
- Sponsor's protocol ID
- 003 (Hepilor)
- Status last verified
- Jun 2019
- First submitted
- 5 Jun 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Evaluation of the Impact of HEPILOR on the Possible Delay in the Development of Dysphagia in Breast Cancer Patients Undergoing Adjuvant Radiotherapy on the Breast/Thoracic Wall and Lymph Node Drainage.
- ClinicalTrials.gov ID
- NCT03997188
- Acronym / sponsor ID
- 003 (Hepilor)
- Conditions
- Breast Cancer Female, Dysphagia, Adjuvant Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cynthia AristeiUniversity, hospital or other
- Study start
- 21 Dec 2015 (actual)
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 25 Jun 2019 (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.
Irradiation of level III and IV draining nodes in breast cancer patients is often associated with dysphagia, requiring treatment with FANS and/or steroids. The present randomized phase III trial determined whether Zinc-L-Carnosine ( Hepilor), prevents or delays the onset of dysphagia in these patients.
Detailed description
. This is a randomized phase III prospective placebo-controlled trial with patients recruited from one single university teaching hospital. Inclusion criteria were: age ≥18 years, breast cancer patients who were candidates for post-operative RT by means of HeT to the breast /chest wall and SC/IC nodes (III-IV levels).Exclusion criteria were: pregnancy or lactation, known or suspected hypersensitivity or allergy to ZLC or to any of the excipients in its oral solution.
All patients were randomized by a pre-determined computer code to two groups.
- HEPILOR arm: patients received ZLC solution
- Placebo arm: patients received a placebo solution Toxicity was assessed weekly in all patients immediately before or after the RT session. Acute toxicity was defined as occurring during RT or in 30 days after it ended and assessed using the Common Terminology Criteria for Adverse Events (CTCAE 4.0 scale). Dysphagia was assessed weekly by means of EAT 10, a self-administered questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- note Study Phase* A medical device is a substance; whose purpose is comparable to the drug ( therapy, prevention, diagnosis, restoration of functions), but it is different from the drug because the drug acts with pharmacological, metabolic and immunological means, while the medical device acts through a mechanical action. Hepilor is a medical device in the form of a syrup with specific properties to protect and repair the gastro-intestinal mucosa. The functional substances of the medical device (Zinc-L-Carnosine and Sodium Alginate) thanks to their mucoadhesive properties act as a physical barrier protecting the damaged areas. In consideration of this we have designed a randomized phase III to to determine whether ZLC prevented or delayed esophagitis in breast cancer patients undergoing HeT to SC/IC lymph nodes and residual breast or chest wall.
| Arm | Type | Receives |
|---|---|---|
| Hepilor arm | Experimental | Device: Hepilorpatients received ZLC solution. The prescribed dose was 10 ml, in the morning and evening, between meals. |
| Placebo arm | Placebo comparator | Device: HepilorPatients received a placebo solution. The prescribed dose was 10 ml, in the morning and evening, between meals |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥18 years
- breast cancer patients who were candidates for post-operative RT by means of HeT to the breast /chest wall and SC/IC nodes (III-IV levels).
Key exclusion criteria (2 listed)
- pregnancy or lactation
- known or suspected hypersensitivity or allergy to ZLC or to any of the excipients in its oral solution.
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 |
|---|---|---|
| HepilorAlso: PlaceboZLC oral suspension and placebo were both started on Day 1 of RT-HeT and ended when RT was completed or at the onset of dysphagia. | Device | Hepilor arm, Placebo arm |
Primary outcome
Zinc-L-Carnosine prevents dysphagia in breast cancer patients undergoing adjuvant radiotherapy: clinical outcome assessed by Eating Assessment Tool (EAT-10) questionaire
Time frame: once a week during the radiotherapy and once at first month of follow-up
The Primary end-point was no dysphagia. The study aim is to assess whether the medical device is able to avoid or delay the onset of dysphagia. The patients were evaluated before the start of radiotherapy and weekly to identify the possible appearance of dysphagia. Dysphagia was assessed weekly by means of self-assessment EAT10 questionnaire that is a tool used to assess objectively the presence of dysphagia, in details (0 = No problem 4 = Severe problem): 1. My swallowing problem has caused me to lose weight; 2. My swallowing problem interferes with my ability to go out for meals; 3. Swallowing liquids takes extra effort; 4. Swallowing solids takes extra effort; 5. Swallowing pills takes extra effort; 6. Swallowing is painful; 7. The pleasure of eating is affected by my wallowing; 8. When I swallow food sticks in my throat; 9. I cough when I eat; 10. Swallowing is stressful.
Degree of dysphagia
Time frame: only in the presence of dysphagia:once a week during the radiotherapy and once at first month of follow-up
The degree of dysphagia was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) 4.0 scale. When the patient showed a score of the questionnaire greater than 3 the target was reached dysphagia was present and this was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Dysphagia =Grade 1: Symptomatic, able to eat regular diet. Grade 2: Symptomatic and altered eating/swallowing. Grade 3: Severely altered eating/swallowing; tube feeding or TPN or hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Cynthia Aristei, MD principal investigator
University Of Perugia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hepilor in people with Breast Cancer Female and Dysphagia, run by Cynthia Aristei 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 25 Jun 2019. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zinc-L-Carnosine prevents dysphagia in breast cancer patients undergoing adjuvant radiotherapy: clinical outcome assessed by Eating Assessment Tool (EAT-10) questionaire (time frame: once a week during the radiotherapy and once at first month of follow-up). The study lists 2 primary outcomes in all. 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 25 Jun 2019.