Annals of Oncology 2: 575-578, 1991. O 1991 Kluwer Academic Publishers. Primed in the Netherlands.
Original article Conservative treatment of postmastectomy lymphedema: A controlled, randomized trial G. Bertelli, M Venturini, G. Forno, F. Macchiavello & D. Dini National Institute for Cancer Research, Dept. of Rehabilitation, Genova, Italy
Summary. A controlled, randomized tried was carried out to evaluate the effectiveness of a new conservative treatment for postmastectomy lymphedema. Seventy-four patients were randomized to wear only an elastic sleeve for six months (group A) or to receive additionally an induction treatment with electrically stimulated lymphatic drainage (group B). The evaluation of results was focused not only on the mean variations in limb measurements in the two groups, but also on the frequency of clinically significant reductions of lymphedema (i.e., at least 25% compared to the initial values). A mean reduction of limb girth of about 17% was obtained in both groups, without significant differences between the two treatments. An 'objective response', however, was not achieved by the majority of patients. On the other hand, compliance to therapy was good and a significant result could be obtained simply and economically also in the group of patients treated only with the elastic sleeve. Key words: breast cancer, electrically stimulated drainage, elastic sleeve, postmastectomy lymphedema, randomized trials Introduction
undergo ESD sessions also wear an elastic sleeve during the day: hence, we decided to form a control group In spite of the fact that postmastectomy lymphedema of patients treated for the same period of time with the has been known for decades [1-3], affecting thousands elastic sleeve alone. Both groups of patients were folof women operated on for breast cancer who are often lowed for six months after the beginning of treatment otherwise free of neoplastic disease, the treatment of to assess maintenance of the response. this disorder has not yet been standardized. This is the result of a lack of both effective therapies and of wellconducted studies. Patients and methods Most patients are managed by conservative means, since no surgical procedure is entirely satisfactory Eligibility criteria [4-6]. There have been recent reports of the effectiveness of different conservative treatments, often based To be eligible, patients were required to have had a on sessions of pneumatic compression of the affected monolateral radical or modified mastectomy or quadlimb or of manual draining massage [7-10]. However, rantectomy with axillary node dissection; to have no even when some form of treatment is reported to have evidence of distant metastases or local relapse; to have produced a good average effect in a study group, it is a mild lymphedema of the homolateral upper limb (see difficult to judge the real benefits for the individual below for definition and measurement criteria), not to patient. Moreover, the concomitant use of elastic have been treated in the last six months, to have no sleeves or bandages, which per se may cause a reduc- signs of lymphangitis and to provide informed consent tion of lymphedema [11], may confuse the interpreta- to be entered in the trial. Patients were excluded if they tion of results. wore a cardiac stimulator or if radiotherapy or chemoThus, with the aim of evaluating the effectiveness of therapy were being administered. a new instrumental treatment of postmastectomy lymphedema and of assessing the possibility of apply- Definition and measurement of lymphedema ing the appropriate methodology of research and evaluation of results in this field, we have designed a con- Limb girth measurements of the affected and contratrolled, randomized trial. The new treatment is an elec- lateral side are recorded at seven matching points: trically stimulated lymphatic drainage (ESD) obtained hand, wrist, lower third of the forearm, upper third of through a sequence of impulses, which, in our experi- the forearm, elbow, lower third of the arm, upper third ence, has yielded encouraging results [12]. Patients who of the arm. The differences in circumference measure-
576 ment between the affected and the contralateral side at each point are added together; the result is termed delta. Only patients with a delta value above 10 centimeters are considered to have a clinically significant lymphedema and admitted into the trial. To restrict variability in the study population, patients with delta > 20 centimeters were excluded. Treatment All patients were instructed to wear a standard (not custom-made) hand-to-shoulder or wrist-to-shoulder elastic sleeve for six hours every day (SigVaris 503). Patients randomized to arm B (see below) also received an induction treatment with ESD (ICH8 Linfomed, Fisioline), applied in two cycles of two weeks each, divided by a 5-week interval. Each cycle consists of 10 30-minute sessions. The frequency of impulses is 4.5 KHz, the intensity being the maximum tolerable by the patient without discomfort. Eight electrodes are employed: the catode is placed on the elbow; the others are distributed from the supraclavicular region to the wrist over lymphatic stations or motor points. The first impulse of each cycle of stimulations drains the supraclavicular lymphatic area; the second sequence of impulses stimulates first the deltoid muscle and then the supraclavicular area again; the third sequence stimulates the triceps, the deltoid and the supraclavicular area and so on until the seventh electrode. This sequence is supposed to produce a deep lymphatic drainage, inducing a lymph flow from the lymphedematous areas of the limb to the lymphatic collectors of the supraclavicular and shoulder region, which are drained and emptied by the first impulses of the cycle. No other concomitant treatment for lymphedema was permitted during the trial. Instructions were given regarding skin care and prophylaxis of infections. Accrual and randomization Seventy-four patients were entered into the trial and randomized to treatment A (elastic sleeve only: 37 patients) or treatment B (elastic sleeve plus two induction cycles of ESD: 37 patients).
responders to treatment, patients who show variations (either a reduction or an increase)
Original article Conservative treatment of postmastectomy lymphedema: A controlled, randomized trial G. Bertelli, M Venturini, G. Forno, F. Macchiavello & D. Dini National Institute for Cancer Research, Dept. of Rehabilitation, Genova, Italy
Summary. A controlled, randomized tried was carried out to evaluate the effectiveness of a new conservative treatment for postmastectomy lymphedema. Seventy-four patients were randomized to wear only an elastic sleeve for six months (group A) or to receive additionally an induction treatment with electrically stimulated lymphatic drainage (group B). The evaluation of results was focused not only on the mean variations in limb measurements in the two groups, but also on the frequency of clinically significant reductions of lymphedema (i.e., at least 25% compared to the initial values). A mean reduction of limb girth of about 17% was obtained in both groups, without significant differences between the two treatments. An 'objective response', however, was not achieved by the majority of patients. On the other hand, compliance to therapy was good and a significant result could be obtained simply and economically also in the group of patients treated only with the elastic sleeve. Key words: breast cancer, electrically stimulated drainage, elastic sleeve, postmastectomy lymphedema, randomized trials Introduction
undergo ESD sessions also wear an elastic sleeve during the day: hence, we decided to form a control group In spite of the fact that postmastectomy lymphedema of patients treated for the same period of time with the has been known for decades [1-3], affecting thousands elastic sleeve alone. Both groups of patients were folof women operated on for breast cancer who are often lowed for six months after the beginning of treatment otherwise free of neoplastic disease, the treatment of to assess maintenance of the response. this disorder has not yet been standardized. This is the result of a lack of both effective therapies and of wellconducted studies. Patients and methods Most patients are managed by conservative means, since no surgical procedure is entirely satisfactory Eligibility criteria [4-6]. There have been recent reports of the effectiveness of different conservative treatments, often based To be eligible, patients were required to have had a on sessions of pneumatic compression of the affected monolateral radical or modified mastectomy or quadlimb or of manual draining massage [7-10]. However, rantectomy with axillary node dissection; to have no even when some form of treatment is reported to have evidence of distant metastases or local relapse; to have produced a good average effect in a study group, it is a mild lymphedema of the homolateral upper limb (see difficult to judge the real benefits for the individual below for definition and measurement criteria), not to patient. Moreover, the concomitant use of elastic have been treated in the last six months, to have no sleeves or bandages, which per se may cause a reduc- signs of lymphangitis and to provide informed consent tion of lymphedema [11], may confuse the interpreta- to be entered in the trial. Patients were excluded if they tion of results. wore a cardiac stimulator or if radiotherapy or chemoThus, with the aim of evaluating the effectiveness of therapy were being administered. a new instrumental treatment of postmastectomy lymphedema and of assessing the possibility of apply- Definition and measurement of lymphedema ing the appropriate methodology of research and evaluation of results in this field, we have designed a con- Limb girth measurements of the affected and contratrolled, randomized trial. The new treatment is an elec- lateral side are recorded at seven matching points: trically stimulated lymphatic drainage (ESD) obtained hand, wrist, lower third of the forearm, upper third of through a sequence of impulses, which, in our experi- the forearm, elbow, lower third of the arm, upper third ence, has yielded encouraging results [12]. Patients who of the arm. The differences in circumference measure-
576 ment between the affected and the contralateral side at each point are added together; the result is termed delta. Only patients with a delta value above 10 centimeters are considered to have a clinically significant lymphedema and admitted into the trial. To restrict variability in the study population, patients with delta > 20 centimeters were excluded. Treatment All patients were instructed to wear a standard (not custom-made) hand-to-shoulder or wrist-to-shoulder elastic sleeve for six hours every day (SigVaris 503). Patients randomized to arm B (see below) also received an induction treatment with ESD (ICH8 Linfomed, Fisioline), applied in two cycles of two weeks each, divided by a 5-week interval. Each cycle consists of 10 30-minute sessions. The frequency of impulses is 4.5 KHz, the intensity being the maximum tolerable by the patient without discomfort. Eight electrodes are employed: the catode is placed on the elbow; the others are distributed from the supraclavicular region to the wrist over lymphatic stations or motor points. The first impulse of each cycle of stimulations drains the supraclavicular lymphatic area; the second sequence of impulses stimulates first the deltoid muscle and then the supraclavicular area again; the third sequence stimulates the triceps, the deltoid and the supraclavicular area and so on until the seventh electrode. This sequence is supposed to produce a deep lymphatic drainage, inducing a lymph flow from the lymphedematous areas of the limb to the lymphatic collectors of the supraclavicular and shoulder region, which are drained and emptied by the first impulses of the cycle. No other concomitant treatment for lymphedema was permitted during the trial. Instructions were given regarding skin care and prophylaxis of infections. Accrual and randomization Seventy-four patients were entered into the trial and randomized to treatment A (elastic sleeve only: 37 patients) or treatment B (elastic sleeve plus two induction cycles of ESD: 37 patients).
responders to treatment, patients who show variations (either a reduction or an increase)
