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

Not Applicable

Completed

• Conditions: Breast Cancer; Hormone Receptor Positive Tumor; Arthralgia
• Interventions: Dietary Supplement: OPERA

• Registration Number: NCT04161833
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2019-03-01
• Status Verified: 2019-11
• Study Completion: 2019-11-01
• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-11
• Last Update Submitted: 2019-11-11
• Study First Posted: 2019-11-13
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Reduction of AI induced arthralgia at 6 months	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)

Secondary Outcome Measures

Name	Time	Method
QoL	6 months	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.')
Compliance	6 months	Compliance to AI therapy (percentage of patients that have not discontinued and/or changed originally prescribed anti-aromatase inhibitor)

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Careggi; 🇮🇹 Florence, Italy