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
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 cryo...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/12/e071756.full |
| _version_ | 1797369940376813568 |
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| author | Claire Duflos Catherine Ferrer Martha Duraes Marion Garbay Gauthier Rathat |
| author_facet | Claire Duflos Catherine Ferrer Martha Duraes Marion Garbay Gauthier Rathat |
| author_sort | Claire Duflos |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-08T17:54:13Z |
| format | Article |
| id | doaj.art-61b114116d904e69ac85132c400d4bbe |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-08T17:54:13Z |
| publishDate | 2023-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-61b114116d904e69ac85132c400d4bbe2024-01-02T05:55:08ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2023-071756Effect of whole-body cryotherapy versus placebo cryotherapy on joint pain induced by aromatase inhibitors in women with early stage breast cancer: a randomised clinical trialClaire Duflos0Catherine Ferrer1Martha Duraes2Marion Garbay3Gauthier Rathat4Clinical Research and Epidemiology unit, CHU Montpellier, Montpellier, FranceDepartment of Obstetrics and Gynecology, CHU Nimes, Nimes, FranceDepartment of Obstetrics and Gynecology, CHU Montpellier, Montpellier, FranceDepartment of Obstetrics and Gynecology, CHU Montpellier, Montpellier, FranceDepartment of Obstetrics and Gynecology, CHU Montpellier, Montpellier, FranceIntroduction 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.https://bmjopen.bmj.com/content/13/12/e071756.full |
| spellingShingle | Claire Duflos Catherine Ferrer Martha Duraes Marion Garbay Gauthier Rathat 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/13/12/e071756.full |
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