A PILOT, PHASE II, MONOCENTRIC STUDY WITHOUT A CONTROL GROUP, ON ACTIVITY AND SAFETY OF HOMEOPATIC MEDICINE ON CANCER RELATED FATIGUE (CRF) AND QUALITY OF LIFE IN PATIENTS UNDER CHEMOTHERAPY

• Conditions: Oncologic patients; MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002337-19-IT
• Lead Sponsor: AZIENDA UNITA' SANITARIA LOCALE DI PARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-07
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified