NCT07199556Completed
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 · Last updated 3 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 22 Sept 2025
- Start date
- 14 Mar 2024
- Primary completion date
- 21 Jul 2025
- Lead sponsor
- Arafarma Group, S.A.
- Diseases
- Childhood cancers
- NCT number
- NCT07199556
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 14 Mar 2024 to the primary completion date, 21 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Known allergy or hypersensitivity to Tenflex®.
Other
- Pregnant or breastfeeding patients.
Who the study is looking for
- 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.
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.