Oncologic patients MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: PHOSPHORUS
Product Code: NA
Pharmaceutical Form: Oral drops
INN or Proposed INN: PHOSPHORUS
CAS Number: 7723-14-0
Concentration unit: pg picogram(s)
Concentration type: equal
Concentrati
Sponsors
AZIENDA UNITA' SANITARIA LOCALE DI PARMA
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - Subjects with anemia (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: the main aim is to explore the activity of the homeopathic remedy on cancer related fatigue (CRF), the most common side effect of cancer treatment, not always well controlled by conventional therapies. The symptom is checked by the BFI questionnaire, internationally validated. The aim therefore is to reach an adequate proportion of success justifying a controlled phase III study on more specific cancer patients.;Secondary Objective: It is interesting to explore the variation of the quality of life in patients under chemotherapy. Also we describe the sample features and provide a monitoring of the clinical parameters together with homeopathic methodology, paying particular attention to remedies used for one type of tumour, homeopathic dilution and homeopathic reactions to the remedy.;Primary end point(s): We misure the scoring of the items 2, 3 and the mean of the scoring of 4a-4f items of BFI questionnaire, completed at the baseline, 1 week after the third chemotherapy cycle, and successively 1 week after every chemotherapy cycle preceding the 2°-3° and 3°-4° medical examinations, as well as following the 4°.;Timepoint(s) of evaluation of this end point: 18-19 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): BFI questionnaire: compare the mean scores at baseline ant at every next step, using repeated measures analysis of variance or non parametric test. EORTC questionaire: mean difference between the baseline-last measure scoring for each EORT-C30 and Supplementary module scale for each cancer.;Timepoint(s) of evaluation of this end point: 18-19 months | — |
Countries
Italy
Contacts
Public ContactSegreteria Scientifica
Comitato Etico Unico per la provincia di Parma
Outcome results
None listed