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Musculoskeletal Pain in Postmenopausal, Early Breast Cancer Patients Receiving Aromatase Inhibitor Therapy - A Pilot Study (AIMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00653718
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : August 24, 2020
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:

In 2005, the EBCIG demonstrated the efficacy of tamoxifen in improving overall survival in hormone receptor positive breast cancers. However, tamoxifen shows partial estrogen agonist activity, which is responsible for the drug's detrimental effects such as endometrial carcinoma, thromboembolism, and tamoxifen resistance. More recently, aromatase inhibitors have been shown to be superior to tamoxifen in the metastatic and adjuvant settings. The ATAC trial demonstrated improved disease-free survival (DFS) for 5 years of anastrozole compared to 5 years of tamoxifen 3. The BIG 1-98 trial results demonstrated that after a median follow-up of 25.8 months, letrozole improved DFS and distant DFS when compared to tamoxifen. Based on these results, adjuvant hormonal therapy with Aromatase Inhibitors (AI) has become the preferred therapy for post-menopausal woman.

However, AI therapy is also associated with toxicities that merit in-depth studies, one of them being an increase in musculoskeletal pain. In the ATAC trial, at a median follow-up of 5.7 years, arthralgia was significantly higher (35.6% vs. 29.4%) and fractures were also increased (11.0% vs. 7.7%) when anastrozole was administered for 5 years following surgery with or without chemotherapy 3. The incidence of arthralgia was also significantly higher in the MA-17 trial, with 25% of patients receiving letrozole developing arthralgia compared with 21% in the placebo group following 5 to 6 years of tamoxifen 5.

Traditionally in cancer clinical trials, the reporting of musculoskeletal pain has been based on the "Common Terminology Criteria for Adverse Events", which covers a wide range of symptoms and does not facilitate the documentation of a pain syndrome in a specific manner. Therefore, there is a need to design a study that will describe the nature of the pain associated with the administration of AI therapy using tools that have been validated for capturing a multidimensional phenomenon such as pain.

Condition or disease
Breast Cancer

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Musculoskeletal Pain in Postmenopausal, Early Breast Cancer Patients Receiving Aromatase Inhibitor Therapy - A Pilot Study
Study Start Date : May 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Musculoskeletal pain [ Time Frame: Every two weeks ]

Secondary Outcome Measures :
  1. Lymphocyte gene expression profiling [ Time Frame: Every two weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Early breast cancer patients

Inclusion Criteria:

  • Female
  • Invasive carcinoma of the breast confirmed by needle biopsy or final pathological evaluation of the surgical specimen
  • Breast cancer Stage I, II or IIIa
  • ER and/or PR+
  • No evidence of metastatic disease
  • Post-menopausal
  • May or may not have received adjuvant or neoadjuvant chemotherapy
  • Bilateral infiltrating carcinoma are eligible

Exclusion Criteria:

  • Men not eligible
  • Other malignancies
  • Patients who have received neoadjuvant or adjuvant endocrine therapy with tamoxifen or an aromatase inhibitor
  • Ongoing treatment with any sex hormonal therapy (these patients are eligible if this therapy is discontinued prior to entry)
  • Therapy with hormonal agent such as raloxifene for osteoporosis
  • Patients receiving glucocorticoids
  • Psychiatric or addictive disorders
  • Inability to read English or French

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00653718

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Canada, Quebec
Centre hospitalier de l'Université de Montréal
Montréal, Quebec, Canada, H2W 1T8
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
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Principal Investigator: André Robidoux, MD Centre hospitalier de l'Université de Montréal (CHUM)
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM) Identifier: NCT00653718    
Other Study ID Numbers: D5390L00068
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: September 2008
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Characterize musculoskeletal pain
Breast cancer patients treated with aromatase inhibitors
Additional relevant MeSH terms:
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Breast Neoplasms
Musculoskeletal Pain
Neoplasms by Site
Breast Diseases
Skin Diseases
Muscular Diseases
Musculoskeletal Diseases
Neurologic Manifestations