Influence of phase I early clinical trials on the quality of life of cancer patients. A pilot study.

A non-randomized, prospective, two-arm pilot study was conducted to assess the impact of clinical phase I trials with new cytotoxic drugs on the quality of life (QOL) of cancer patients, comparing a 10-item linear analog self-assessment (LASA) and Karnofsky performance scale (KPS) of 18 patients treated in phase I protocols versus 8 patients treated with standard/low efficacy cytotoxic or endocrine 1-2 drug regimens. There was no negative significant influence of treatment in phase I protocols either on LASA and KPS at the times before, during and after study or on changes (delta LASA, delta KPS) occurring with treatment. On the contrary, there was a slight positive influence of treatment within phase I protocols on self-assessed social activity (delta LASA) and on delta KPS when the groups were compared throughout the complete observation period. In addition, within the total study population there was significant positive influence of overall anticancer medication on psychological and social aspects of LASA, as indicated by feeling of well being, mood, level of activity and level of anxiety. Moreover, KPS and questions regarding appetite within LASA correlated with prognosis as measured by survival time, and intra-individual response comparison revealed the dominance of a differentiated reliable response type among our patients.