Breast CancerAIANCT04161833
Opera® for Aromatase Inhibitor-related Arthralgia Management (AIA)
A study testing OPERA in people with Breast Cancer and Hormone Receptor Positive Tumor, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
In this phase II, multicenter, self-controlled clinical trial, we will evaluate the safety and efficacy of OPERA® for treating anti-aromate inhibitors (AIs) induced arthralgia. The diagnosis of arthralgia will be based on the NCI-CTCAE v4.0 grade of ≥ 1 , A disorder characterized by a sensation of marked discomfort in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Hormone Receptor Positive Tumor, Arthralgia
- What is being tested?
- OPERA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2018to 1 Nov 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Karnofsky performance score≥70
- Indication for AI treatment in adjuvant setting for breast cancer
- Arthralgia with grade ≥0-1
Who cannot join
- Concomitant diseases, e.g. diabetes, renal insufficiency, alcohol abuse
- Concomitant rheumatological disease (Rheumatoid arthritis, Spondyloarthropathies, Psoriatic arthritis, etc.)
- Concomitant endocrinological disease (Acromegaly , Emocromatosis, etc)
- Any conditions that would complicate arthralgia assessment (e.g. Trauma, Glucocorticoid withdrawal, Hypertrophic osteoarthropathy, Osteoarthritis, Avascular necrosis, Gout, Systemic lupus erythematosus, Septic arthritis, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of an Alfa-lipoic, Methylsulfonylmethane and Bromelain Dietary Supplement (Opera®) for Aromatase Inhibitor-related Arthralgia Management (AIA)
In this phase II, multicenter, self-controlled clinical trial, we will evaluate the safety and efficacy of OPERA® for treating anti-aromate inhibitors (AIs) induced arthralgia. The diagnosis of arthralgia will be based on the NCI-CTCAE v4.0 grade of ≥ 1 , A disorder characterized by a sensation of marked discomfort in a joint, mild pain (grade 1). Arthralgia will be assessed at the enrollment and every two months until the sixth month.
Read the detailed description
Aromatase Inhibitors (AIs) are recommended for the adjuvant treatment of hormone receptor positive breast cancers in the post-menopausal population. Compared with Tamoxifen, third generation aromatase inhibitors have been shown to significantly improve disease free survival (DFS), and include the steroidal inhibitor exemestane, and the nonsteroidal inhibitors, anastrozole and letrozole. Although the AIs are associated with fewer thromboembolic events and endometrial abnormalities than is tamoxifen, approximately 25% of postmenopausal women on AI report arthralgia, skeletal, and muscle pain. The multicentre double-blind placebo-controlled ma.17 trial by the National Cancer Institute of Canada Clinical Trials Group revealed marked increases in arthralgia (25% vs. 21%) and myalgia (15% vs. 12%) in patients on letrozole as compared with those on placebo. The Intergroup Exemestane Study shown a link between arthralgia and the ai exemestane (5.4% exemestane vs. 3.6% tamoxifen).The Arimidex, Tamoxifen Alone or in Combination (atac) trial, after 68 months' median follow-up, showed that the incidence of arthralgia was significantly higher in the anastrozole group than in the tamoxifen group [1100 of 3092 (35.6%) vs. 911 of 3094 (29.4%) patients]. Currently, evidences of drugs efficacy to reduce these side effects are sparse.OPERA® (GAMFARMA srl, Milan, Italy) is a new dietary supplement where α-Lipoic acid (240mg), BS (40mg), MSM (200mg) and Bromelain (20mg) are combined together in a single hard-gelatin capsule. The aim of this prospective study is to determine the efficacy and safety of OPERA® supplementation in a series of patients affected by arthralgia during AI treatment.
- Conditions
- Breast Cancer, Hormone Receptor Positive Tumor, Arthralgia
- Being tested
- OPERA
- Keywords
- breast cancer, luminal tumor, anti-aromatase inhibitors, arthralgia, dietary supplement
- Medical subject headings
- Breast Neoplasms, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPERADietary supplement
All patients were required to take an OPERA® capsule (dietary supplement where α-lipoic acid, Boswellia Serrata, methylsulfonylmethane and bromelain are combined in a single capsule) once daily,from enrollment up to sixth months.
| Study group | Role | What they receive |
|---|---|---|
| OPERA | Experimental | Women receiving adjuvant aromates-inhibitor with arhtralgia grade ≥ 1 (CTACAE 4.03) Receives: Dietary Supplement: OPERA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of AI induced arthralgia at 6 months
Reduction of AI-induced arthralgia assessed with VAS scale (0, no pain, to 5, worst pain)
Measured: 6 months
Reduction of AI induced arthralgia at 6 months
Reduction of AI-induced arthralgia assessed with PRAI questionnaire (16 items that query pain severity over the last 7 days in eight joints using a rating scale of 0-10, with 10 being greatest severity)
Measured: 6 months
Secondary outcomes (2)
QoL
Quality of life assessed with FACT-ES questionnaire (19 items which assess endocrine complaints and adverse effects with response scores ranging from 0 to 4 ('not at all', 'a little bit', 'somewhat', 'quite a bit', and 'very much.')
Measured: 6 months
Compliance
Compliance to AI therapy (percentage of patients that have not discontinued and/or changed originally prescribed anti-aromatase inhibitor)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Nov 2018
- Primary completion1 Mar 2019
- Study completion1 Nov 2019
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.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Isacco Desideri, MD, Principal investigator, Radiation Oncology Unit, AOU CareggiLorenzo Livi, MD, Study chair, Radiation Oncology Unit, AOU Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161833
- Sponsor's protocol ID
- OPERA2
- Acronym
- AIA
- Status last verified
- Nov 2019
- First submitted
- 8 Nov 2019
- Last updated
- 13 Nov 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 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Alfa-lipoic, Methylsulfonylmethane and Bromelain Dietary Supplement (Opera®) for Aromatase Inhibitor-related Arthralgia Management (AIA)
- ClinicalTrials.gov ID
- NCT04161833
- Acronym / sponsor ID
- AIA / OPERA2
- Conditions
- Breast Cancer, Hormone Receptor Positive Tumor, Arthralgia
- Keywords
- breast cancer, luminal tumor, anti-aromatase inhibitors, arthralgia, dietary supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 13 Nov 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.
In this phase II, multicenter, self-controlled clinical trial, we will evaluate the safety and efficacy of OPERA® for treating anti-aromate inhibitors (AIs) induced arthralgia. The diagnosis of arthralgia will be based on the NCI-CTCAE v4.0 grade of ≥ 1 , A disorder characterized by a sensation of marked discomfort in a joint, mild pain (grade 1). Arthralgia will be assessed at the enrollment and every two months until the sixth month.
Detailed description
Aromatase Inhibitors (AIs) are recommended for the adjuvant treatment of hormone receptor positive breast cancers in the post-menopausal population. Compared with Tamoxifen, third generation aromatase inhibitors have been shown to significantly improve disease free survival (DFS), and include the steroidal inhibitor exemestane, and the nonsteroidal inhibitors, anastrozole and letrozole. Although the AIs are associated with fewer thromboembolic events and endometrial abnormalities than is tamoxifen, approximately 25% of postmenopausal women on AI report arthralgia, skeletal, and muscle pain. The multicentre double-blind placebo-controlled ma.17 trial by the National Cancer Institute of Canada Clinical Trials Group revealed marked increases in arthralgia (25% vs. 21%) and myalgia (15% vs. 12%) in patients on letrozole as compared with those on placebo. The Intergroup Exemestane Study shown a link between arthralgia and the ai exemestane (5.4% exemestane vs. 3.6% tamoxifen).The Arimidex, Tamoxifen Alone or in Combination (atac) trial, after 68 months' median follow-up, showed that the incidence of arthralgia was significantly higher in the anastrozole group than in the tamoxifen group [1100 of 3092 (35.6%) vs. 911 of 3094 (29.4%) patients]. Currently, evidences of drugs efficacy to reduce these side effects are sparse.OPERA® (GAMFARMA srl, Milan, Italy) is a new dietary supplement where α-Lipoic acid (240mg), BS (40mg), MSM (200mg) and Bromelain (20mg) are combined together in a single hard-gelatin capsule. The aim of this prospective study is to determine the efficacy and safety of OPERA® supplementation in a series of patients affected by arthralgia during AI treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPERA | Experimental | Dietary Supplement: OPERAWomen receiving adjuvant aromates-inhibitor with arhtralgia grade ≥ 1 (CTACAE 4.03) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Karnofsky performance score≥70
- Indication for AI treatment in adjuvant setting for breast cancer
- Arthralgia with grade ≥0-1
Key exclusion criteria (4 listed)
- Concomitant diseases, e.g. diabetes, renal insufficiency, alcohol abuse
- Concomitant rheumatological disease (Rheumatoid arthritis, Spondyloarthropathies, Psoriatic arthritis, etc.)
- Concomitant endocrinological disease (Acromegaly , Emocromatosis, etc)
- Any conditions that would complicate arthralgia assessment (e.g. Trauma, Glucocorticoid withdrawal, Hypertrophic osteoarthropathy, Osteoarthritis, Avascular necrosis, Gout, Systemic lupus erythematosus, Septic arthritis, etc.)
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 |
|---|---|---|
| OPERAAll patients were required to take an OPERA® capsule (dietary supplement where α-lipoic acid, Boswellia Serrata, methylsulfonylmethane and bromelain are combined in a single capsule) once daily,from enrollment up to sixth months. | Dietary supplement | OPERA |
Primary outcome
Reduction of AI induced arthralgia at 6 months
Time frame: 6 months
Reduction of AI-induced arthralgia assessed with VAS scale (0, no pain, to 5, worst pain)
Reduction of AI induced arthralgia at 6 months
Time frame: 6 months
Reduction of AI-induced arthralgia assessed with PRAI questionnaire (16 items that query pain severity over the last 7 days in eight joints using a rating scale of 0-10, with 10 being greatest severity)
2 secondary outcomes
QoL
Time frame: 6 months
Compliance
Time frame: 6 months
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 13 Nov 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.
Isacco Desideri, MD principal investigator
Radiation Oncology Unit, AOU Careggi
Lorenzo Livi, MD study chair
Radiation Oncology Unit, AOU Careggi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPERA in people with Breast Cancer and Hormone Receptor Positive Tumor, run by Azienda Ospedaliero-Universitaria Careggi 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 4 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 13 Nov 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. 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?
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?
Reduction of AI induced arthralgia at 6 months (time frame: 6 months). 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 13 Nov 2019.