NCT06806072

Brief 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?

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Feb 2025May 2027

First Submitted

Initial submission to the registry

January 23, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

February 10, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

1.6 years

First QC Date

January 23, 2025

Last Update Submit

January 30, 2025

Conditions

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

Keywords

breast cancerbalneotherapyendocrine therapy

Outcome Measures

Primary Outcomes (1)

  • Changes in musculo-skeletal pain

    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.

    7 months

Secondary Outcomes (3)

  • Changes in quality of life

    7 months

  • Changes in sleep quality

    7 months

  • Changes in anxiety and depression symptoms

    7 months

Study Arms (2)

Balneotherapy group

EXPERIMENTAL

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.

Other: Balneotherapy

Control group

NO INTERVENTION

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.

Interventions

BalneotherapyOTHER

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

Balneotherapy group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is focused on endogen estrogenic suppression in premenopausal women so biological women are the only eligible candidates for this study.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parc de Recerca Biomèdica de Barcelona

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Balneology

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Natalia Garcia-Giralt, PhD

CONTACT

0034933160497ngarcia@researchmar.net

Diana Ovejero, MD, PhD

CONTACT

dovejero@researchmar.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2025

First Posted

February 3, 2025

Study Start

February 10, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)