title: Open-label uncontrolled pilot study to evaluate complementary therapy with Ruta graveolens 9c in patients with advanced cancer.
abstract: BACKGROUND
  Patients with advanced metastatic disease are often treated aggressively with multiple lines of chemotherapy, even in the last month of life. The benefit of such an approach remains uncertain. The objective of the study was to investigate whether Ruta graveolens 9c homeopathic medicine can improve quality of life (QoL) and tumour progression in patients with advanced cancer.
  
  
  METHODS
  This was a single-centre, open-label, uncontrolled, pilot study. Patients (>18-years, life-expectancy ≥3 months, performance status ≤2) with locally-advanced solid tumours or metastases, previously treated with all available standard anti-cancer treatments were recruited. Oral treatment consisted of two 1-mL ampoules of Ruta graveolens (9c dilution) given daily for a minimum of 8 weeks, or until tumour and/or clinical progression. Primary outcome was QoL measured using the EORTC QLQ-C30 questionnaire. Secondary outcome measures were anxiety/depression measured using the Hospital Anxiety and Depression Scale (HADS), WHO performance status (PS), tumour progression assessed using RECIST criteria and tumour markers, survival and tolerance.
  
  
  RESULTS
  Thirty-one patients were included (mean age: 64.3 years). Mean duration of treatment was 3.3 months (median: 2.1). QoL global health status improved significantly between baseline and week 8 (P < 0.001) and week 16 (P = 0.035), but was at the limit of significance (P = 0.057) at the end of the study. There was no significant change in anxiety/depression or PS during treatment. Ruta graveolens 9c had no obvious effect on tumour progression. Median survival was 6.7 months [95%CI: 4.8-14.9]. Ruta graveolens 9c was well-tolerated.
  
  
  CONCLUSIONS
  Some patients treated with Ruta graveolens 9c had a transitory improvement in QoL, but the effectiveness of this treatment remains to be confirmed in further studies.
authors.affiliation: Université de Lyon, Hospices Civils de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, Pierre-Bénite, France. Electronic address: gilles.freyer@univ-lyon1.fr.
authors.forename: Gilles
authors.initials: G
authors.lastname: Freyer
authors.affiliation: Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH - phase 1 - INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France.
authors.forename: Benoit
authors.initials: B
authors.lastname: You
authors.affiliation: BOIRON, 2 avenue de l'ouest lyonnais, 69510 Messimy, France.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Villet
authors.affiliation: Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH - phase 1 - INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Tartas
authors.affiliation: Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH - phase 1 - INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Fournel-Federico
authors.affiliation: Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH - phase 1 - INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Trillet-Lenoir
authors.affiliation: Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH - phase 1 - INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France.
authors.forename: Salima
authors.initials: S
authors.lastname: Hamizi
authors.affiliation: Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH - phase 1 - INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Colomban
authors.affiliation: Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH - phase 1 - INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Chavernoz
authors.affiliation: Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH - phase 1 - INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Falandry
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D000529:Complementary Therapies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy*; D009369:Neoplasms / Q000188:drug therapy*; D008517:Phytotherapy; D010865:Pilot Projects; D028321:Plant Preparations / Q000008:administration & dosage*; D032105:Ruta / Q000737:chemistry*; D017211:Treatment Failure
chemical_list: D000970:Antineoplastic Agents; D028321:Plant Preparations
keywords: Advanced cancer; Best supportive care; Pilot study; Quality of life; Ruta graveolens 9c; Treatment failure