Stages III Skin MelanomaPhase 2NCT01988831
Efficacy of Propranolol Treatment to Prevent Melanoma Progression
A Phase 2 study testing Propranolol hydrochloride in people with Stages III Skin Melanoma and Stages II Skin Melanoma, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Melanoma's incidence is increasing worldwide. The efforts made in melanoma screening led to an earlier detection of the primary tumour and a better prognosis, but melanoma remains an aggressive cancer when it comes to its metastatic stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stages III Skin Melanoma, Stages II Skin Melanoma, Stage IB Skin Melanoma
- What is being tested?
- Propranolol hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2016to Mar 2022
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient over 18 y.o
- Breslow index > 1mm or any Breslow index with ulcerated primary lesion
- Melanoma stage AJCC Ib, IIa, IIb, IIc, IIIa, IIIb or IIIc
- Able to undergo outpatient treatment
Who cannot join
- No contra indication for betablockers as defined by the compendium
- No clinical evidence of coagulopathy
- No unstable angina pectoris
- No AV-block II or III without pacemaker
- No severe congestive heart failure
- No untreated phaeochromocytoma
Show all 21Show fewer
- No severe bradycardia
- No severe hypotension
- No severe impairment of peripheral arterial circulation
- No uncontrolled cardiac arrhythmia
- No severe asthma or COPD
- No uncontrolled diabetes mellitus
- No Angioneurotic edema
- No severe Aortic valve stenosis
- No severe hypertrophic cardiomyopathy
- No severe renal dysfunction
- No patients on beta blockers by inclusion
- No known adverse reaction to betablockers
- No pregnant or lactating patients can be included
- No melanoma stage AJCC IV by inclusion
- No patients requiring a specific oncological treatment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hôpital universitaire de Genève
Geneva, Canton of Geneva, 1211
About this study
Official title: Phase 2 Prospective Study of the Efficacy of Propranolol on Malignant Melanoma Progression. A Randomized Placebo-controlled,Single Blind Trial
Melanoma's incidence is increasing worldwide. The efforts made in melanoma screening led to an earlier detection of the primary tumour and a better prognosis, but melanoma remains an aggressive cancer when it comes to its metastatic stage. Three recent retrospective studies compared groups of patients diagnosed with primary melanoma and treated with betablockers for another indication to patients who never received betablockers. In these three studies, the outcome of the disease is significantly better for people under betablocker treatment with a decreased rate of recurrence and a better 5 years survival rate. Here we want to investigate the efficacy and the tolerability of an adjuvant treatment with propranolol for patients suffering from a primary melanoma with a high risk of recurrence.
- Being tested
- Propranolol hydrochloride, Placebo pill
- Keywords
- Malignant melanoma, betablocker, propranolol, interventional, prospective, adjuvant, recurrence
- Medical subject headings
- Melanoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol hydrochlorideDrug
Also called Inderal, Avlocardyl, Hemipralon LP, Propranolol EG
This intervention apply to Propranolol group
Placebo pillDrug
We use placebo pills alike propranolol commercial pills to ensure blindness of the subjects during the study.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 113 patients will be enrolled in the placebo group with respect to randomization.
Placebo group will be prescribed placebo pills in the same packaging as propranolol treated group.
The frequency and duration of the treatment is the same as propranolol arm. The placebo group will have the same cardiology consultation as propranolol treated group to ensure the respect of blindness. Receives: Drug: Placebo pill |
| Betablocker | Experimental | drug: 'Propranolol hydrochloride' 338 patients will be enrolled in the "Propranolol" Group and treated with propranolol.
The dosage will be determined by the cardiologist as the maximum tolerated dose to a maximum of 160mg/day.
One long acting pill a day until an evidence of disease progression or the end of the study. Receives: Drug: Propranolol hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence
The efficacy of propranolol treatment will be tested in one interim analysis when the last patient enrolled have reached one year of follow up and one final analysis when the last patient enrolled have reached three years of follow up. The primary endpoint of the study will be the progression of the disease.
We will measure the efficacy of a propranolol treatment on the risk of progression of the disease.
Measured: five years
Secondary outcomes (2)
Use of serum microRNA profile as a predictor for recurrence
We will investigate the microRNA profile in the serum of patients of both groups during the whole study to identify biomarkers specific for recurrence.
Measured: 5 years
Overall survival
We investigate the impact of propranolol treatment on the 5 years survival.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startJun 2016
- Primary completionJan 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: We must delay the study for some financial reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stages III Skin MelanomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Gal, University Hospital, Geneva
- Investigators
- Frédérique-Anne Le Gal, MD/PhD, Principal investigator, Hôpital cantonal universitaire de Genève
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988831
- Sponsor's protocol ID
- HUG-MEL-BB
- Status last verified
- May 2019
- First submitted
- 13 Nov 2013
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
De Giorgi V, Grazzini M, Gandini S, Benemei S, Lotti T, Marchionni N, Geppetti P. Treatment with beta-blockers and reduced disease progression in patients with thick melanoma. Arch Intern Med. 2011 Apr 25;171(8):779-81. doi: 10.1001/archinternmed.2011.131.
PubMed 21518948Lemeshow S, Sorensen HT, Phillips G, Yang EV, Antonsen S, Riis AH, Lesinski GB, Jackson R, Glaser R. beta-Blockers and survival among Danish patients with malignant melanoma: a population-based cohort study. Cancer Epidemiol Biomarkers Prev. 2011 Oct;20(10):2273-9. doi: 10.1158/1055-9965.EPI-11-0249. Epub 2011 Sep 20.
PubMed 21933972De Giorgi V, Gandini S, Grazzini M, Benemei S, Marchionni N, Geppetti P. Effect of beta-blockers and other antihypertensive drugs on the risk of melanoma recurrence and death. Mayo Clin Proc. 2013 Nov;88(11):1196-203. doi: 10.1016/j.mayocp.2013.09.001.
PubMed 24182700
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Prospective Study of the Efficacy of Propranolol on Malignant Melanoma Progression. A Randomized Placebo-controlled,Single Blind Trial
- ClinicalTrials.gov ID
- NCT01988831
- Acronym / sponsor ID
- HUG-MEL-BB
- Keywords
- Malignant melanoma, betablocker, propranolol, interventional, prospective, adjuvant, recurrence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: We must delay the study for some financial reasons
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 20 Nov 2013 (estimated)
- 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.
Melanoma's incidence is increasing worldwide. The efforts made in melanoma screening led to an earlier detection of the primary tumour and a better prognosis, but melanoma remains an aggressive cancer when it comes to its metastatic stage. Three recent retrospective studies compared groups of patients diagnosed with primary melanoma and treated with betablockers for another indication to patients who never received betablockers. In these three studies, the outcome of the disease is significantly better for people under betablocker treatment with a decreased rate of recurrence and a better 5 years survival rate. Here we want to investigate the efficacy and the tolerability of an adjuvant treatment with propranolol for patients suffering from a primary melanoma with a high risk of recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo pill113 patients will be enrolled in the placebo group with respect to randomization. Placebo group will be prescribed placebo pills in the same packaging as propranolol treated group. The frequency and duration of the treatment is the same as propranolol arm. The placebo group will have the same cardiology consultation as propranolol treated group to ensure the respect of blindness. |
| Betablocker | Experimental | Drug: Propranolol hydrochloridedrug: 'Propranolol hydrochloride' 338 patients will be enrolled in the "Propranolol" Group and treated with propranolol. The dosage will be determined by the cardiologist as the maximum tolerated dose to a maximum of 160mg/day. One long acting pill a day until an evidence of disease progression or the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient over 18 y.o
- Breslow index > 1mm or any Breslow index with ulcerated primary lesion
- Melanoma stage AJCC Ib, IIa, IIb, IIc, IIIa, IIIb or IIIc
- Able to undergo outpatient treatment
Key exclusion criteria (21 listed)
- No contra indication for betablockers as defined by the compendium
- No clinical evidence of coagulopathy
- No unstable angina pectoris
- No AV-block II or III without pacemaker
- No severe congestive heart failure
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 |
|---|---|---|
| Propranolol hydrochlorideAlso: Inderal, Avlocardyl, Hemipralon LP, Propranolol EGThis intervention apply to Propranolol group | Drug | Betablocker |
| Placebo pillWe use placebo pills alike propranolol commercial pills to ensure blindness of the subjects during the study. | Drug | Placebo |
Primary outcome
Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence
Time frame: five years
The efficacy of propranolol treatment will be tested in one interim analysis when the last patient enrolled have reached one year of follow up and one final analysis when the last patient enrolled have reached three years of follow up. The primary endpoint of the study will be the progression of the disease. We will measure the efficacy of a propranolol treatment on the risk of progression of the disease.
2 secondary outcomes
Use of serum microRNA profile as a predictor for recurrence
Time frame: 5 years
Overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Background: PubMed 21518948De Giorgi V, Grazzini M, Gandini S, Benemei S, Lotti T, Marchionni N, Geppetti P. Treatment with beta-blockers and reduced disease progression in patients with thick melanoma. Arch Intern Med. 2011 Apr 25;171(8):779-81. doi: 10.1001/archinternmed.2011.131.
- Background: PubMed 21933972Lemeshow S, Sorensen HT, Phillips G, Yang EV, Antonsen S, Riis AH, Lesinski GB, Jackson R, Glaser R. beta-Blockers and survival among Danish patients with malignant melanoma: a population-based cohort study. Cancer Epidemiol Biomarkers Prev. 2011 Oct;20(10):2273-9. doi: 10.1158/1055-9965.EPI-11-0249. Epub 2011 Sep 20.
- Background: PubMed 24182700De Giorgi V, Gandini S, Grazzini M, Benemei S, Marchionni N, Geppetti P. Effect of beta-blockers and other antihypertensive drugs on the risk of melanoma recurrence and death. Mayo Clin Proc. 2013 Nov;88(11):1196-203. doi: 10.1016/j.mayocp.2013.09.001.
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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.
Frédérique-Anne Le Gal, MD/PhD principal investigator
Hôpital cantonal universitaire de Genève
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol hydrochloride in people with Stages III Skin Melanoma and Stages II Skin Melanoma, run by University Hospital, Geneva at 1 site in Switzerland.
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 21 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: paused, as of the sponsor's last update on 10 May 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 Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01988831, which also lists 3 linked publications.
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 10 May 2019.