Clinical trial · Interventional
Impact of a Food Supplement on Musculoskeletal Pain in Women With Breast Cancer Treated With Aromatase Inhibitors.
Study of the Impact of a Nutraceutical on Pain in Women With Musculoskeletal Symptoms Associated With Hormonal Therapy With Aromatase Inhibitors, in ER and/or PgR Positive Breast Cancer, After Antitumor Therapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Food supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- There is only one arm in the study. All patients will be treated with the experimental food supplement.
- interventionNames
- Dietary Supplement: Food supplement
Primary outcomes (1)
- measure
- Change in average pain intensity modified Brief Pain Inventory - Short Form (mBPI-sf).
- timeFrame
- Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
- description
- 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.
Secondary outcomes (4)
- measure
- Change in quality of life Short Form 12-Item Health Survey (SF-12).
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
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