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Clinical Trials in Spain / NCT06806072
Starting soon Not applicable

BALNEOTHERAPY FOR BREAST CANCER PATIENTS UNDERGOING ENDOCRINE THERAPY

NCT06806072 · tracked via the Priya Life Science Spain tracker
Sponsor
Parc de Salut Mar
Phase
Not applicable
Started
2025-02-10
Last updated
2025-02-03

Condition(s) studied

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Investigational drug(s) / intervention(s)

Balneotherapy

Balneotherapy: The intervention consists in 3 weekly sessions of balneotherapy during 4 weeks.

Study summary

Endocrine therapy is the mainstay of adjuvant therapy in premenopausal women with hormone receptive-positive (HR+) breast cancer as it has been demonstrated that it reduces long-term recurrences and increases survivial. However, this therapy, which suppresses estrogen production and estrogen-induced effects, is associated with the development of joint pain which can significantly reduce quality of life and lead to treatment discontinuation.

The main question the study aims o answer is:

Can balneotherapy (BT) alleviate muscle-skeletal pain (primary objective) derived from endocrine therapy and improve quality of life (secondary objective) in young women with HR+ breast cancer?

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: Premenopausal women diagnosed with early-stage hormonal receptor (HR+) breast cancer (stages I-III) undergoing ovarian suppression and aromatase inhibitor therapy (i.e., endocrine therapy) for at least three months. \- Reported musculoskeletal pain (VAS score ≥2) associated with the initiation of the endocrine therapy. Exclusion Criteria * Chronic musculoskeletal conditions predating the initiation of endocrine therapy and/or unrelated to effects derived from the endocrine therapy (i.e. fibromyalgia) * Anxiety-depression syndrome predating the initiation of endocrine therapy that is treated with drugs. * Fear of water * Fecal and/or urinary incontinence * Severe venous insufficiency * Epilepsy and physical disabilities that may hinder the performance of Balneotherapy (BT)/aquatic exercises.

Primary outcome measure(s)

  • Changes in musculo-skeletal pain — 7 months
    The primary objective is to determine changes in pain levels through the visual analogic scale (VAS) in the third and second timepoints vs baseline in all participants and to compare these outcomes between participants in the BT and control groups.

Trial sites (1)

FacilityCityRegionStatus
Parc de Recerca Biomèdica de Barcelona Barcelona Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06806072 on ClinicalTrials.gov ↗ ← All trials in Spain