Impact of a Food Supplement on Musculoskeletal Pain in Women With Breast Cancer Treated With Aromatase Inhibitors.

NCT07199556 | Completed

• 1 other identifier: ARA-EXP/TEN-2023-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Change in quality of life Short Form 12-Item Health Survey (SF-12).

  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'.

  Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.

• Percentage of patients with ≥30% reduction in average pain.

  Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.

• Changes in other mBPI-sf domains.

  Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.

Study Arms (1)

Experimental

EXPERIMENTAL

There is only one arm in the study. All patients will be treated with the experimental food supplement.

Dietary Supplement: Food supplement

Interventions

Food supplement DIETARY_SUPPLEMENT

Tenflex® is an authorized food supplement.

Experimental

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arafarma Group, S.A.: lead

Study Sites (1)

Hospital Clínic Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: March 14, 2024
• Primary Completion: July 21, 2025
• Study Completion: September 10, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

ES (1)