Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Musculoskeletal Diseases

Symptoms and General Pathology

Nervous System Diseases

Breast Neoplasms

Arthralgia

Joint Diseases

Pain

Neurologic Manifestations

Micronutrients

All Drugs and Chemicals

Anti-Inflammatory Agents

Herbal and Botanical

Other Dietary Supplements

Thioctic Acid

Aromatase Inhibitors

Dimethyl sulfone

Indian Frankincense

Alpha-lipoic Acid

MSM (Methylsulfonylmethane)

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

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

Isacco Desideri, MD

Lorenzo Livi, MD

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.

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.

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)

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

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)

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 to AI therapy (percentage of patients that have not discontinued and/or changed originally prescribed anti-aromatase inhibitor)

Azienda Ospedaliero-Universitaria Careggi

Professor

Blood and Lymph Conditions

Lymphedema

Lymphatic Diseases

Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction

Robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction

Current breast cancer surgery is achieving minimally invasive approach to reduce incision while providing better surgical vision and freedom in mastectomy. Breast reconstruction with free deep inferior epigastric artery perforator (DIEP) flap was considered the gold standard, however, the donor site morbidity remains an endless concern. Here we applied robotic-assisted surgery in both mastectomy and free DIEP flap harvest, so-called Oncoplastic Entirely Robot-Assisted Approach (OPERA).

A retrospective chart review identified 14 patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction. The patient demographics and mastectomy and flap characteristics were reviewed.

OPERA - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

Oncoplastic Entirely Robot-Assisted Approach (OPERA) - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

The length of incision on anterior rectus sheath

The time it took to dissect pedicles with robotic arms

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Opera® for Aromatase Inhibitor-related Arthralgia Management (AIA)	NCT04161833	Breast Cancer Hormone Recepto... Arthralgia	OPERA	18 Years -	Azienda Ospedaliero-Universitaria Careggi
Opera® for Aromatase Inhibitor-related Arthralgia Management (AIA)	NCT04161833	Breast Cancer Hormone Recepto... Arthralgia	OPERA	18 Years -	Azienda Ospedaliero-Universitaria Careggi
OPERA - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction	NCT06415526	Breast Cancer Mastectomy; Lym...	OPERA	20 Years - 80 Years	Chang Gung Memorial Hospital

Spots Global Cancer Trial Database for opera

Every month we try and update this database with for opera cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for opera

Every month we try and update this database with for opera cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for opera cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.