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 food supplement may help improve pain in these patients with musculoskeletal symptoms associated with hormone therapy in ER- and/or PR-positive breast cancer.
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 patients with breast cancer. The administration of food supplement may result in an improvement of pain, as measured by the mBPI-sf questionnaire, in patients undergoing treatment with Aromatase Inhibitors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
Tenflex® is an authorized food supplement.
Hospital Clínic Barcelona
Barcelona, Spain
Change in average pain intensity modified Brief Pain Inventory - Short Form (mBPI-sf).
To evaluate the change in average pain intensity as measured by the modified Brief Pain Inventory-Short Form (mBPI-sf) from baseline to Weeks 4, 8, 12, and 24 of treatment with Tenflex. It contains 11 items and these score 0 to 10 being higher the worse pain.
Time frame: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
Change in quality of life Short Form 12-Item Health Survey (SF-12).
To evaluate the change of the quality of life questionnaire SF-12 from baseline to Weeks 4, 8, 12, and 24 of treatment with Tenflex. This survey measures eight health domains (Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE), Mental Health (MH)), which are summarized into two components summary scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). Higher scores are better health status.
Time frame: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
Change in quality of life 'BREAST-Q Reconstruction/Reduction/Augmentation Module'.
To evaluate the change of the quality of life questionnaire Breast-Q from baseline to Weeks 4, 8, 12, and 24 of treatment with Tenflex. It contains differents scales and their raw scores are converted into a scale from 0 (worst possible outcome) to 100 (best possible outcome).
Time frame: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
Percentage of patients with ≥30% reduction in average pain.
To calculate the percentage of patients with 30% reduction in average pain from baseline to Weeks 4, 8, 12, and 24 of treatment with Tenflex.
Time frame: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
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Changes in other mBPI-sf domains.
To evaluate changes in other mBPI-sf domains (general activity, mood, walking ability, normal work, relations with others, sleep, enjoyment of life) from baseline to Weeks 4, 8, 12, and 24.
Time frame: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.