A PHASE II EXPLORATIVE STUDY EVALUATING ACTIVITY AND SAFETY OF HOMEOPATHIC MEDICINE ON CANCER RELATED FATIGUE (CRF) AND QUALITY OF LIFE IN ONCOLOGIC PATIENTS UNDER CHEMOTHERAPY IN DAY HOSPITAL AT FIDENZA GENERAL HOSPITAL (PR)- STUDY DH -HOMEOPATHY - STUDY DH-HOMEOPATHY

AZIENDA UNITA' SANITARIA LOCALE DI PARMA0 个研究点目标入组 48 人开始时间: 2012年3月7日最近更新: 2014年5月12日

适应症

试验速览

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•Subjects of male and female gender, 18 years older, under chemotherapy: 1) adjuvant and with no relapse of illness 2) with metastatic progressive illness after a first line chemotherapy and have to begin or are under a second or third line chemotherapy Ø patients with CRF that have a score of almost 4 in item 2 of BFI questionnaire, measured at baseline. Ø Subjects treated for malignancy of tumours, both solid and haematological, with EORTC supplementary module available. Ø Subjects able to sign the informed consent and to complete the questionnaires independently.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 18
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- Subjects with anemia (Hb < 9 g/dl, HT < 30%), reduction of Hb =/> 2 g/dl in the preceding month - Subjects with co-morbidities, evaluated during the first oncologic visit , that could be associated to fatigue: 1) hypothyroidism not controlled by therapy 2) insomnia 3) diabetes with HBA1C values lower than 9% in the last control 4) anxiety under therapy by not more than two months or with continous adjusting dose 5) subject in anticipation of radiotherapy or surgery 6) hypertension not controlled with drugs 7) acute or chronic respiratory insufficiency 8) women in pregnancy or breast-feeding - subjects included in other studies of conventional or not conventional medicine -Variation in BFI score greater than 1 point, between the three measures or the first and the third one, performed before the baseline

发起方

AZIENDA UNITA' SANITARIA LOCALE DI PARMA