A phase II randomized clinical trial to determine the effectiveness of goreisan and saireito for lower limb lymphedema in women treated for gynecologic cancer

JRCT ID: jRCT1041190019

Registered date:18/04/2019

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Lower Limb Lymphedema
• Date of first enrollment: 20/11/2019
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Administration of Goreisan or Saireito + complex therapy

Outcome(s)

• Primary Outcome: Comparison of calculated limb volume

Secondary Outcome

Comparison of limb water
Comparison of QOL indicator

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1) Patients who underwent uterine malignancy surgery including retroperitoneal lymph node dissection or surgical operation of the uterine appendix malignant tumor by preoperative diagnosis of gynecological malignancy
2) Patients diagnosed with secondary lymphedema in 1)
3) Patients with ECOG-PS 0 or 1
4) Patients whose main organ functions are adequately maintained
(A) White blood cell count 3,500 / mm 3 12 000 / mm 3
(B) Number of neutrophils 1,500 / mm 3
(C) Number of platelets 100,000 / mm 3
(D) Hb 9.0 g / dL
(E) AST,ALT 100 IU / L
(F) Creatinine 1.2 mg / dL
5) Patients whose age at registration is 20 years or older
6) Patients who have obtained document consent

Exclude criteria

1) Patients who are allergic to the ingredients of traditional Chinese medicine or goriso-san/saireito
2) Patients with severe complications (heart failure, renal failure, liver failure, hypoactive nutrition etc.) and severe mental illness
3) Patients whose oral ingestion is impossible
4) Patients diagnosed with primary lymphedema
5) Patients with lower extremity vein thrombosis
6) In addition, patients judged unsuitable for doctors to safely carry out this study

Related Information

• Primary Sponsor: Kajiyama Hiroaki