NCT04457895: SKYPE2

A Randomized, Open-labelled, Controlled Trial Evaluating the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.

Recruiting now NA Last updated 2 June 2026

What this trial tests

NA trial testing educational yoga program in Breast Cancer in 108 participants. Currently enrolling.

Timeline

11 February 2021

Primary endpoint
1 August 2028

1 August 2028

Quick facts

Lead sponsor	Institut du Cancer de Montpellier - Val d'Aurelle
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	108
Start date	11 February 2021
Primary completion	1 August 2028
Estimated completion	1 August 2028
Sites	7 locations across France

Drugs / interventions tested

• educational yoga program
• no intervention

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle — full company profile →

Who can join

Adults 18 to 99, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• the efficacy of a combined intervention of physical therapy and yoga, including patient education with a control group for confirmed osteoarticular and/or musculoskeletal pain (≥4) due to hormone therapy in patients treated for breast cancer.
  Time frame: 12 weeks
  Rate of patients with a 2-point reduction on the Numeric Pain Rating Scale (NPRS) of osteoarticular and/or musculoskeletal pain due to hormonal therapy treatment between T0 (inclusion) and T2 (end of treatment).

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Importance of Patient Education for At-home Yoga Practice in Women With Hormonal Therapy-induced Pain During Adjuvant Breast Cancer Treatment: A Feasibility Study.
   Faravel K, Huteau ME, Jarlier M, de Forges H, et al · · 2021 · cited 4× · PMID 34939444 · DOI 10.1177/15347354211063791
2. Yoga for fatigue in people with cancer.
   Messer S, Oeser A, Wagner C, Wender A, et al · · 2025 · cited 2× · PMID 40421669 · DOI 10.1002/14651858.cd015520
3. Efficacy of a physiotherapy, yoga and patient education programme for patients with breast cancer and hormone therapy-induced pain: a multicentre randomised study protocol (SKYPE 2).
   Faravel K, Jarlier M, Meignant L, Thomaso M, et al · · 2024 · PMID 38191246 · DOI 10.1136/bmjopen-2023-075378