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

NCT04161833 | Completed

• 1 other identifier: OPERA2
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Hormone Receptor Positive Tumor; Arthralgia

Keywords

breast cancer; luminal tumor; anti-aromatase inhibitors; arthralgia; dietary supplement

Outcome Measures

Primary Outcomes (2)

• Reduction of AI induced arthralgia at 6 months

  Reduction of AI-induced arthralgia assessed with VAS scale (0, no pain, to 5, worst pain)

  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)

  6 months

Secondary Outcomes (2)

• QoL

  6 months

• Compliance

  6 months

Study Arms (1)

OPERA

EXPERIMENTAL

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

Dietary Supplement: OPERA

Interventions

OPERA DIETARY_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.

OPERA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Karnofsky performance score≥70
• Indication for AI treatment in adjuvant setting for breast cancer
• Arthralgia with grade ≥0-1

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Careggi

Florence, 50100, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Isacco Desideri, MD

  Radiation Oncology Unit, AOU Careggi

  PRINCIPAL INVESTIGATOR

• Lorenzo Livi, MD

  Radiation Oncology Unit, AOU Careggi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: November 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)