AN EXPLORATORY-STUDY OF FREQUENT PAIN MEASUREMENT IN A CANCER CLINICAL-TRIAL

The ideal methodology for quality of life (QOL) measurement in cancer clinical trials matches the evaluation to the anticipated outcomes, th ereby increasing the likelihood that clinically relevant changes are c aptured. The present study explored the importance of such methodologi cal 'tailoring' in a phase II trial of paclitaxel and recombinant huma n granulocyte-colony stimulating factor (rhG-CSF) for metastatic breas t cancer. Prior to the trial, clinical observation suggested that freq uent short-lived episodes of pain might occur during this treatment re gimen, Twenty-one patients provided longitudinal data for at least thr ee cycles of chemotherapy. To assess transient pain, a routine QOL ass essment at baseline and every third cycle was supplemented with pain m easurements twice weekly. The interval assessment included a multi-dim ensional QOL instrument (Functional Living Index-Cancer) and measures of psychological state (Rand Mental Health Inventory), symptom distres s (Memorial Symptom Assessment Scale), and performance status (Karnofs ky Performance Status Score). The frequent pain measurements were acqu ired using visual analogue and categorical scales for pain intensity ( Memorial Pain Assessment Card). From baseline to the end of cycle thre e, global pain scores declined and the results on other QOL measures w ere variable, The data obtained using these measures did not reveal th e existence of episodic pains. in contrast, the twice weekly pain meas urements clearly demonstrated transient severe pains in approximately half the patients. These data highlight the importance of specific mea surement of troubling symptoms or other relevant QOL concerns at clini cally appropriate intervals during the routine QOL assessment of clini cal trials, The additional burden involved in these assessments is war ranted if the information derived is highly relevant, would not be ade quately captured otherwise and could improve therapy.