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BALNEOTHERAPY FOR BREAST CANCER PATIENTS UNDERGOING ENDOCRINE THERAPY

ConditionBreast Cancer Early Stage Breast Cancer (Stage 1-3)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorParc de Salut Mar

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Balneotherapy

    Other intervention

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

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Balneotherapy groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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.

Time frame
7 months

Secondary outcomes

1

Changes in quality of life

To asses changes in quality-of-life scores through the SF-36 questionnaire in the third and second timepoints vs baseline in all participants and to compare these outcomes between participants in the BT and control groups.

Time frame
7 months
2

Changes in sleep quality

To asses the changes in sleep quality and sleep disturbances through the Pittsburgh Sleep Quality Index (PSQI) in the third and second timepoints vs baseline in all participants and to compare these outcomes between participants in the BT and control groups.

Time frame
7 months
3

Changes in anxiety and depression symptoms

To assess the changes in anxiety and depression symptoms through the Hospital Anxiety and Depression Scale (HADS) in the third and second timepoints vs baseline in all participants and to compare these outcomes between participants in the BT and control groups.

Time frame
7 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Parc de Salut Mar

Lead sponsor

Caldes de Montbui's City Council

Collaborator

European Regional Development Fund

Collaborator

Biomedical Research Networking Center on Frailty and Healthy Aging (CIBERFES)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: