Opera® for Aromatase Inhibitor-related Arthralgia Management (AIA)

Use of an Alfa-lipoic, Methylsulfonylmethane and Bromelain Dietary Supplement (Opera®) for Aromatase Inhibitor-related Arthralgia Management (AIA)

Sponsors

Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Source Azienda Ospedaliero-Universitaria Careggi
Brief 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 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.

Overall Status Completed
Start Date November 1, 2018
Completion Date November 1, 2019
Primary Completion Date March 1, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Reduction of AI induced arthralgia at 6 months 6 months
Reduction of AI induced arthralgia at 6 months 6 months
Secondary Outcome
Measure Time Frame
QoL 6 months
Compliance 6 months
Enrollment 53
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: OPERA

Description: 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.

Arm Group Label: OPERA

Eligibility

Criteria:

Inclusion Criteria:

- 18 years or older

- Karnofsky performance score≥70

- Indication for AI treatment in adjuvant setting for breast cancer

- Arthralgia with grade ≥0-1

Exclusion Criteria:

- 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.)

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: Azienda Ospedaliero Universitaria Careggi
Location Countries

Italy

Verification Date

November 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Azienda Ospedaliero-Universitaria Careggi

Investigator Full Name: Lorenzo Livi

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: OPERA

Type: Experimental

Description: Women receiving adjuvant aromates-inhibitor with arhtralgia grade ≥ 1 (CTACAE 4.03)

Acronym AIA
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov