Clinical trial · Interventional
BALNEOTHERAPY FOR BREAST CANCER PATIENTS UNDERGOING ENDOCRINE THERAPY
EFFECTS OF BALNEOTHERAPY IN BREAST CANCER PATIENTS UNDERGOING ENDOCRINE 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)
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?
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 Early Stage Breast Cancer (Stage 1-3) | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Balneotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Balneotherapy group
- description
- These participants will be premenopausal women with estrogen receptor positive early breast cancer treated with adjuvant endocrine therapy allocated to receive 4 weeks of 3 weekly sessions of balneotherapy.
- interventionNames
- Other: Balneotherapy
- type
- NO_INTERVENTION
- label
- Control group
- description
- These participants will be premenopausal women with estrogen receptor positive early breast cancer treated with adjuvant endocrine therapy that will not receive balneotherapy but that will be asked to respond to the same scales and questionnaires as the balneotherapy group at the same timepoints.
Primary outcomes (1)
- measure
- Changes in musculo-skeletal pain
- timeFrame
- 7 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available