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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | There is only one arm in the study. All patients will be treated with the experimental food supplement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food supplement | Dietary Supplement | Tenflex® is an authorized food supplement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic Barcelona | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| 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). | 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. | 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. | Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit. |
| D017437 |
| Skin and Connective Tissue Diseases |