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

Arafarma

Status

Completed

Conditions

Breast Cancer

Treatments

Dietary Supplement: Food supplement

Study type

Interventional

Funder types

Industry

Identifiers

NCT07199556

ARA-EXP/TEN-2023-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 patients

Sex

Female

Volunteers

No Healthy Volunteers

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.