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 citations
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- Nonprofit
- Association Montpellier reine a du coeur
- University or hospital
- Groupement de Coopération Sanitaire (GCS), Missions d’Enseignement, de recherche, de reference et d’Innovation of Montpellier and Nimes
Based on 2 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2023-12-01 · BMJ Open · vol. 13 · issue 12 · p. e071756
- Publisher
- BMJ
- Cited
- 3 citations · more than 60% of similar papers · 0.3× the field average
- References
- 42 works
- Access
- Open access (journal) · CC-BY-NC
- Research areas
- Exercise and Physiological Responses · Effects of Radiation Exposure · Management of metastatic bone disease
- Keywords
- 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 authors
From FR
- Martha Duraes · correspondingCentre Hospitalier Universitaire de Montpellier
- Marion GarbayCentre Hospitalier Universitaire de Montpellier
- Catherine FerrerCentre Hospitalier Universitaire de Nîmes
- Claire DuflosCentre Hospitalier Universitaire de Montpellier
- Gauthier RathatCentre Hospitalier Universitaire de Montpellier
Abstract
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.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC).
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