An interventional study of Food supplement in Breast Cancer, sponsored by Arafarma Group, S.A.. Completed at 1 site in Spain. Open to female participants. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Arafarma Group, S.A. · Not applicable, Interventional, and Other
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Arafarma Group, S.A. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
There is only one arm in the study. All patients will be treated with the experimental food supplement.
Dietary Supplement: Food supplement
Tenflex® is an authorized food supplement.
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.
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.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Arafarma Group, S.A.