Status:
COMPLETED
Impact of a Food Supplement on Musculoskeletal Pain in Women With Breast Cancer Treated With Aromatase Inhibitors.
Lead Sponsor:
Arafarma Group, S.A.
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
NA
Brief Summary
The aim of this pilot study is to assess the change in pain, measured with the Modified Brief Pain Inventory - Short Form (mBPI-sf), at 4, 8, and 12 weeks. The collagen- and chondroitin sulfate-based ...
Detailed Description
ER- and/or PR-positive breast cancer is treated with hormone therapy. There is a relationship between the administration of hormone therapy and the presence and/or exacerbation of joint pain in patien...
Eligibility Criteria
Inclusion
- Women with histologically confirmed hormone receptor-positive breast carcinoma, without evidence of metastatic disease (M0).
- Surgical treatment completed and any surgery-related complications resolved.
- Currently receiving hormonal therapy with aromatase inhibitors (AIs) for at least 21 days, with pain symptoms lasting less than 6 months attributable to AIs, and with a treatment plan to continue for at least an additional 180 days (6 months).
- Musculoskeletal symptoms associated with hormonal therapy that began or worsened after initiation of such therapy. New musculoskeletal pain must not be specifically due to fractures or traumatic injuries.
- "Average pain" score of at least 4, as assessed by the mBPI-sf questionnaire within 7 days prior to enrollment or baseline visit.
- ECOG performance status of 0-2.
- Patients able to provide informed consent.
Exclusion
- Concurrent medical or arthritic conditions that may confound or interfere with the assessment of pain or efficacy, such as rheumatologic/inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica) or cancer that may affect bone.
- Chemotherapy and/or radiotherapy completed within 28 days prior to enrollment or baseline visit, and/or unresolved Grade ≥2 side effects related to chemotherapy and/or radiotherapy, except for alopecia and peripheral neuropathy.
- Known allergy or hypersensitivity to Tenflex®.
- Pregnant or breastfeeding patients.
Key Trial Info
Start Date :
March 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07199556
Start Date
March 14 2024
End Date
September 10 2025
Last Update
October 3 2025
Active Locations (1)
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1
Hospital Clínic Barcelona
Barcelona, Spain, 08036