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.

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).