The effect of aroma lymphatic tressage for lower extremity edema associated with the taxane chemotherapy in patients with breast cancer: A phase 2 clinical trial.

초록

Background: Taxane-associated lower extremity edema is a distinctive adverse effect of taxane, which severely compromise patients’ quality-of-life. Aroma lymphatic tressage (ALT) has been established as a complementary technique that uses a combination of aromatherapy and hand massage to relieve distress and modulate lymphatic drainage in cancer patients. This study aimed to evaluate the symptomrelieving efficacy of a short course ALT on taxane-induced lower extremity edema. Methods: Patients treated with taxane-based chemotherapy for early or advanced stage breast cancer were screened for the study. Patients were enrolled when they presented more than CTCAE G3 of lower-extremity edema. A total of 8 sessions of ALT were applied twice a week for 4 weeks after completing taxane. The primary endpoint was to determine the leg circumference change before and after receiving ALT. Patients’ subjective degree of edema, and quality-of-life were also assessed. Results: A total of 37 patients completed all sessions of planned treatment. All of the participants were female, with the median age of 55.4-years-old. 30.8% of them were premenopausal. The median height of the patients was 157.6cm, median weight was 60.9kg, and median BMI was 1.6kg/m2. Most of the patients received docetaxel (87.2%). The baseline thigh, calf, and ankle circumferences were 56.5cm, 37.4cm, and 22.6cm, each. After 8 sessions of ALT, the median circumferences decreased to 54.7cm, 36.2cm, and 21.9cm. 23 (62.2%) participants experienced a 3% or more reduction in circumference change with a month of ALT. Patients’ subjective degree of edema decreased 56.9% for 4 weeks compared to baseline, while mean body weight decreased from 62.6kg to 61.2kg. All the differences before and after the ALT were statistically significant (p-value < 0.0001) Most of the indicators assessing patients’ quality-of-life improved during the ALT periods, especially physical subscale (from 14.8 to 19.1, p-value < 0.0001). EORTC-QLQ-C30 score also improved from 70.8 to 57.1 (p-value < 0.0001). Conclusions: To our knowledge, this is the first clinical trial to evaluate clinical efficacy of ALT on taxane-associated lower extremity edema. Patients who received ALT after taxane-based chemotherapy presented significant decline of leg circumference and improvement of QoL.