Effect of whole-body cryotherapy versus placebo cryotherapy on joint pain induced by aromatase inhibitors in women with early stage breast cancer: a randomised clinical trial
Duraes M, Garbay M, Ferrer C, Duflos C, Rathat G
BMJ open · 2 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- Association Montpellier reine a du coeur
- Universidad u hospital
- Groupement de Coopération Sanitaire (GCS), Missions d’Enseignement, de recherche, de reference et d’Innovation of Montpellier and Nimes
Según 2 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2023-12-01 · BMJ Open · vol. 13 · número 12 · pág. e071756
- Editorial
- BMJ
- Citado
- 3 citas · más que el 60% de estudios similares · 0.3× el promedio de su campo
- Referencias
- 42 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY-NC
- Áreas de investigación
- Exercise and Physiological Responses · Effects of Radiation Exposure · Management of metastatic bone disease
- Palabras clave
- Medicine, Cryotherapy, Aromatase, Breast cancer, Placebo, Clinical trial, Stage (stratigraphy), Aromatase inhibitor, Physical therapy, Randomized controlled trial, Cancer, Internal medicine, Gynecology, Surgery, Alternative medicine, Pathology
- MeSH
- humans, breast neoplasms, arthralgia, pain, hormones, analgesics, aromatase inhibitors, cryotherapy, double-blind method, quality of life, female
5 autores
- Martha Duraes🇫🇷 · autor de correspondenciaCentre Hospitalier Universitaire de Montpellier
- Marion Garbay🇫🇷Centre Hospitalier Universitaire de Montpellier
- Catherine Ferrer🇫🇷Centre Hospitalier Universitaire de Nîmes
- Claire Duflos🇫🇷Centre Hospitalier Universitaire de Montpellier
- Gauthier Rathat🇫🇷Centre Hospitalier Universitaire de Montpellier
Resumen
El texto original del estudio, en el idioma en que se publicó.
Introduction
Hormone therapy (HT) is a major adjuvant treatment for breast cancer. Despite their effectiveness, aromatase inhibitors can cause several side effects, including arthralgia in 35%-50% of patients. These side effects frequently lead to the premature discontinuation of HT. Whole-body cryotherapy (WBC) can be used for managing arthritic pain. The primary objective of this study will be to evaluate the effect of WBC on aromatase-induced joint pain, compared with placebo cryotherapy, in patients with hormone-dependent breast cancer receiving adjuvant aromatase inhibitors. The secondary objectives will be to evaluate WBC safety and its effect on analgesic consumption, HT adherence and quality of life.
Methods and analysis
In this randomised, placebo-controlled, double-blinded clinical trial, 56 patients with aromatase inhibitor-induced joint pain and a Brief Pain Inventory-Short Form (BPI-SF) score ≥3 for the worst pain experienced in the previous week will be randomised into the WBC or placebo cryotherapy arm (10 sessions in each group). The primary outcome will be the BPI-SF score at week 6 post-treatment. The secondary outcomes will include the BPI-SF scores at months 3 and 6 post-treatment, the BPI-SF pain severity index and pain interference index, the Health Assessment Questionnaire score, the number of days of aromatase inhibitor treatment and analgesic consumption in the 15 days before the visits at week 6 and months 3 and 6 after cryotherapy. The incidence of adverse events will also be investigated.
Ethics and dissemination
Ethics approval was obtained from the Ethics Committee Est IV of Hospital Civil, Strasbourg, France. Protocol V.5 was approved in December 2022. The results will be disseminated in a peer-reviewed journal and presented at international congresses.
Trial registration number
NCT05315011.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC).
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