Multi-center rater-blinded study of early intervention with the Hand Incubator for breast cancer-related lymphedema (the BEAT-EDEMA trial): Proposal of a research protocol

Postoperative lymphedema is considered irreversible once it has developed, and significantly lowers the patient’s quality of life. However, lymphatic function has recently been clarified, and it is possible that lymphedema can be cured if early treatment is started. This two-arm randomized clinical trial (UMIN000026124) will prospectively evaluate 24 patients with early-stage breast cancer-related lymphedema at the Nagoya University Hospital and Aichi Cancer Center Hospital. The eligibility criteria will be patients who are diagnosed with stage 0–1 breast cancer-related lymphedema, as defined by the International Society of Lymphology, within 12 weeks after breast cancer surgery. The diagnosis of lymphedema will be confirmed using a bioimpedance spectroscopy device (L-Dex®). Participants will be randomized 1:1 into the intervention and control groups. The physicians and patients will be aware of their group assignment, although treatment efficacy will be evaluated by raters who are blinded to the group assignments. The intervention group will complete grasping exercises in the Hand Incubator device for 4 weeks. The primary outcome will be the change in the affected upper limb’s volume after the intervention, as measured using the water displacement method. This study may help establish a standard treatment for postoperative lymphedema.