Randomised clinical trial of a manual therapy programme to reduce the evolution time of axillary web syndrome in women affected by breast cancer: study protocol

Jesús Baltasar González Rubino, Maria Jesus Vinolo-Gil, Cristina García Muñoz, Rocío Martín-Valero, Jesús Baltasar González Rubino, Maria Jesus Vinolo-Gil, Cristina García Muñoz, Rocío Martín-Valero

Abstract

Introduction: Breast cancer is the most common malignant tumour in women, with more than 2 million new cases annually worldwide. One of the most frequent and well-known surgical and post-actinic sequelae is post-mastectomy lymphoedema. The axillary web syndrome is another sequela that limits the functionality of the patient and delays the protocol time of administering cancer treatments; and in many cases, this sequela is misdiagnosed. This surgical sequela usually disappears spontaneously after the third month of appearance, but this implies a long period of discomfort and limitations for the patient, at the same time, it may delay the application of radiotherapy within the indicated protocol deadline (due to a need for body posture).

Methods and analysis: With the present quasi-experimental study, we intend to show the application of physiotherapy and stretching from the beginning of the appearance of the axillary cord, in a controlled and scheduled way by the physiotherapist. It is possible to reduce the time in which the lymphatic thrombus is present and, therefore, recover functionality and mobility, reduce pain and be able to apply treatments within the established deadline. We intend to apply this therapy into the intervention group and compare thrombus evolution time with the control group.

Ethics and dissemination: This trial has the approval of the Andalucía Ethics Committee (PEIBA code 1909-N1-21, reg. number 171.21).

Trial registration number: ClinicalTrials.gov Registry (NCT05115799).

Keywords: Breast tumours; EDUCATION & TRAINING (see Medical Education & Training); RADIOTHERAPY; REHABILITATION MEDICINE.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study design. AWS, axillary web syndrome; DASH, Disabilities of the Arm, Shoulder and Hand; IPAQ, International Physical Activity Questionnaire; ROM, range of motion; VAS, Visual Analogue Scale; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality Life Questionnarie Core 30

References

    1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin 2015;65:5–29. 10.3322/caac.21254
    1. . Available: [Accessed 23 Jun 2022].
    1. López-Sánchez I, Casado-Méndez PR, Santos-Fonseca RS. Prevalencia de factores de riesgo del cáncer de mama en población rural femenina. Rev Arch Médico Camagüey 2019;23:563–72.
    1. Sancho-Garnier H, Presse CM. Breast cancer epidemiology. Med 2019;48:1076–84. 10.1016/j.lpm.2019.09.022
    1. Waks AG, Winer EP. Breast cancer treatment: a review. JAMA 2019;321:288–300. 10.1001/jama.2018.19323
    1. Gillespie TC, Sayegh HE, Brunelle CL, et al. . Breast cancer-related lymphedema: risk factors, precautionary measures, and treatments. Gland Surg 2018;7:379–403. 10.21037/gs.2017.11.04
    1. Shao Y, Zhong D-S, Eur J. Manual lymphatic drainage for breast cancer-related lymphoedema. Eur J Cancer Care 2017;26:e12517. 10.1111/ecc.12517
    1. Soriano-Maldonado A, Carrera-Ruiz Álvaro, Díez-Fernández DM, et al. . Effects of a 12-week resistance and aerobic exercise program on muscular strength and quality of life in breast cancer survivors: study protocol for the EFICAN randomized controlled trial. Medicine 2019;98:e17625. 10.1097/MD.0000000000017625
    1. Tastaban E, Soyder A, Aydin E, et al. . Role of intermittent pneumatic compression in the treatment of breast cancer-related lymphoedema: a randomized controlled trial. Clin Rehabil 2020;34:220–8. 10.1177/0269215519888792
    1. Yeung WM, McPhail SM, Kuys SS. A systematic review of axillary web syndrome (AWS). J Cancer Surviv 2015;9:576–98. 10.1007/s11764-015-0435-1
    1. Furlan C, Matheus CN, Jales RM, et al. . Vascular alterations in axillary and brachial vessels in patients with axillary web syndrome after breast cancer surgery. Lymphat Res Biol 2018;16:287–93. 10.1089/lrb.2017.0037
    1. Leduc O, Fumière E, Banse S, et al. . Identification and description of the axillary web syndrome (AWS) by clinical signs, MRI and US imaging. Lymphology 2014;47:164–76.
    1. Jacob T, Bracha J. Identification of signs and symptoms of axillary web syndrome and breast seroma during a course of physical therapy 7 months after lumpectomy: a case report. Phys Ther 2019;99:229–39. 10.1093/ptj/pzy110
    1. Koehler LA, Hunter DW, Haddad TC, et al. . Characterizing axillary web syndrome: ultrasonographic efficacy. Lymphology 2014;47:156–63.
    1. Koehler LA, Blaes AH, Haddad TC, et al. . Movement, function, pain, and postoperative edema in axillary web syndrome. Phys Ther 2015;95:1345–53. 10.2522/ptj.20140377
    1. Yao Y, Chu Y, Xu B, et al. . Radiotherapy after surgery has significant survival benefits for patients with triple-negative breast cancer. Cancer Med 2019;8:554–63. 10.1002/cam4.1954
    1. Hickey BE, Francis DP, Lehman M. Sequencing of chemotherapy and radiotherapy for early breast cancer. Cochrane Database Syst Rev 2013;4:CD005212. 10.1002/14651858.CD005212.pub3
    1. Xu H-P, Bronsart E, Costa É, et al. . Patterns of locoregional failure in women with early-stage breast cancer treated by whole breast irradiation in the lateral isocentric decubitus position: large-scale single-centre experience. Cancer Radiother 2019;23:116–24. 10.1016/j.canrad.2018.08.002
    1. Baggi F, Nevola Teixeira LF, Gandini S, et al. . Axillary web syndrome assessment using a self-assessment questionnaire: a prospective cohort study. Support Care Cancer 2018;26:2801–7. 10.1007/s00520-018-4123-3
    1. Huang H-C, Liu H-H, Yin L-Y, et al. . High incidence of axillary web syndrome among breast cancer survivors after breast reconstruction. Breast Care 2020;15:366–71. 10.1159/000501928
    1. Ramírez-Parada K, Garay-Acevedo D, Mella-Abarca W, et al. . Axillary web syndrome among Chilean women with breast cancer: incidence and possible predisposing factors. Support Care Cancer 2020;28:2941–7. 10.1007/s00520-019-05190-5
    1. Foster RL. Reporting guidelines: consort, PRISMA, and Squire. J Spec Pediatr Nurs 2012;17:1–2. 10.1111/j.1744-6155.2011.00319.x
    1. Ostos-Díaz B, Casuso-Holgado MJ, Muñoz-Fernández MJ, et al. . Early physical rehabilitation after sentinel lymph node biopsy in breast cancer: is it feasible and safe? Int J Environ Res Public Health 2020;17. doi:10.3390/ijerph17228382. [Epub ahead of print: 12 11 2020].
    1. Muñoz Fernández MJ. Implementación de Una intervención de fisioterapia precoz para La recuperación de Cicatrices quirúrgicas Y del miembro superior tras biopsia selectiva de ganglio centinela: ensayo controlado multicéntrico aleatorizado. In: Tesis doctoral. Sevilla: Universidad de Sevilla, 2021.
    1. SECHC . Available: [Accessed 23 Jun 2022].
    1. Fisterra . Available: [Accessed 23 Jun 2022].
    1. Vrotsou K, Ávila M, Machón M, et al. . Constant-Murley score: systematic review and standardized evaluation in different shoulder pathologies. Qual Life Res 2018;27:2217–26. 10.1007/s11136-018-1875-7
    1. Budtz CR, Andersen JH, de Vos Andersen N-B, et al. . Responsiveness and minimal important change for the quick-DASH in patients with shoulder disorders. Health Qual Life Outcomes 2018;16:226. 10.1186/s12955-018-1052-2
    1. NIH . Available: [Accessed 23 Jun 2022].
    1. Lee PH, Macfarlane DJ, Lam TH, et al. . Validity of the International physical activity questionnaire short form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act 2011;8:115. 10.1186/1479-5868-8-115
    1. Arraras JI, Asin G, Illarramendi JJ, et al. . The EORTC QLQ-ELD14 questionnaire for elderly cancer patients. validation study for elderly Spanish breast cancer patients. Rev Esp Geriatr Gerontol 2019;54:321–8. 10.1016/j.regg.2019.05.001
    1. Ryans K, Davies CC, Gaw G, et al. . Incidence and predictors of axillary web syndrome and its association with lymphedema in women following breast cancer treatment: a retrospective study. Support Care Cancer 2020;28:5881–8. 10.1007/s00520-020-05424-x
    1. Cho Y, Do J, Jung S, et al. . Effects of a physical therapy program combined with manual lymphatic drainage on shoulder function, quality of life, lymphedema incidence, and pain in breast cancer patients with axillary web syndrome following axillary dissection. Support Care Cancer 2016;24:2047–57. 10.1007/s00520-015-3005-1
    1. Fourie WJ, Robb KA. Physiotherapy management of axillary web syndrome following breast cancer treatment: discussing the use of soft tissue techniques. Physiotherapy 2009;95:314–20. 10.1016/j.physio.2009.05.001
    1. Wariss BR, Costa RM, Pereira ACPR, et al. . Axillary web syndrome is not a risk factor for lymphoedema after 10 years of follow-up. Support Care Cancer 2017;25:465–70. 10.1007/s00520-016-3424-7
    1. Klein I, Kalichman L, Chen N, et al. . Effect of physical activity levels on oncological breast surgery recovery: a prospective cohort study. Sci Rep 2021;11:10432. 10.1038/s41598-021-89908-8
    1. Marcos AL, El Gaaied ABA, Ayed FB. Lymphedema of the arm after surgery for breast cancer: new physiotherapy. Clin Exp Obstet Gynecol 2012;39:483–8.

Source: PubMed

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