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Evaluation of the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.

Study acronym: SKYPE2
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv19
  2. Minor Publications: details revised at 1 of 20 entriesv18
  3. Minor Site details revised at 1 of 7 sitesv17
  4. Minor Re-verified, no change to tracked fieldsv16
  5. Minor Study sites: 6 to 7v15
Show 13 earlier versionsHide 13 earlier versions
  1. Notable Primary and study completion dates: Aug 2025 to Aug 2028v14
  2. Minor Re-verified, no change to tracked fieldsv13
  3. Minor Secondary endpoints revised (14)
    • Site details revised at 1 of 6 sites
    v12
  4. Minor Site details revised at 1 of 6 sitesv11
  5. Notable Primary and study completion dates: Oct 2022 to Aug 2025
    • Study sites: 7 to 6
    v10
  6. Minor Study sites: 6 to 7v9
  7. Minor Publications: 12 to 20v8
  8. Minor Publications: details revised at 10 of 12 entriesv7
  9. Minor Primary and study completion dates: Jun 2022 to Oct 2022v6
  10. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2021 to Feb 11, 2021
    • Site details revised at 6 of 6 sites
    v5
  11. Notable Start date: Nov 2020 to Feb 2021v4
  12. Minor Start date: Oct 2020 to Nov 2020v3
  13. Minor Start date: Sep 2020 to Oct 2020v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
As much as 50% of patients treated with hormonotherapy (HT) for breast cancer (BC) suffer from osteoarticular pain during treatment. Secondary effects have become a real issue because of their consequences on the patients' quality of life, but also on treatment efficacy and survival when they induce dose reduction or premature withdrawal of treatment. Additional medicines (acupuncture, hypnosis, yoga) have become more and more popular these last years. 48 to 80% of patients with BC eventually choose them. A review comparing efficacy of various therapies to decrease osteoarticular pain concludes to a highest efficacy of anti-inflammatory treatments, paracetamol and yoga. It thus appears innovative to complete this care with a patient educational project (PEP) in postural yoga instructed by a trained physical therapist, which will enable patients to practice yoga postures at home by themselves. The investigators conducted a pilot study "SKYPE" with 24 algic patients treated with HT after BC, whose results are very promising. The investigators now propose in the continuity of the pilot study a multicenter randomized controlled study comparing the efficacy of SKYPE care on pain reduction, an educative care combining physical therapy and yoga, to a control group in patients treated with HT for a BC with osteoarticular and/or musculoskeletal pain. Furthermore, in order to examine whether yoga interventions may influence inflammation through their effects on the level of a wide range of pro- and anti-inflammatory cytokines (30), the investigators will Change in circulating cytokines' level between baseline level (T0) and post-treatment level (T2) in both groups will be analyzed and if so correlation will be established.
Trial Details
NCT Number NCT04457895
Lead Sponsor Institut du Cancer de Montpellier - Val d'Aurelle
Conditions
(from sponsor)
Breast Cancer
Related terms Breast Neoplasms
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov