Prospective validation of patient fatigue questionnaire (FACIT-F) for fatigue assessment in nab-paclitaxel plus gemcitabine therapy.

Following the recent introduction of a stronger regimen for pancreatic carcinoma, patients undergoing chemotherapy present high incidences of fatigue. The feasibility and validity of evaluating fatigue by questionnaire for patients with unresectable pancreatic cancer (URPC) receiving this recent regimen of chemotherapy remains unclear. Enrolled patients completed the Functional Assessment of Cancer Therapy-Fatigue questionnaire (FACIT-F, version 4), a questionnaire regarding additional concerns, a numerical rating scale test concerning loss of appetite, an evaluation of degree of pain and sensory disorder, and the Patient Neurotoxicity Questionnaire (PNQ) before undergoing nab-paclitaxel plus gemcitabine therapy. Questionnaires and tests were completed on registration day, and then weekly during therapy over an 8-week period as the initial two cycles of continuous regimen. This trial is registered on the UMIN Clinical Trials Registry (UMIN000021758). Between April 2016 and September 2016, 10 consecutive patients with URPC, including metastatic (n=4) and locally advanced pancreatic (n=6) cancer, were registered, and scheduled for nab-paclitaxel plus gemcitabine therapy. The mean maximum values of fatigue degree increased from mean baseline values in all categories of the questionnaire (6-500%). The degree of fatigue presented a spike pattern over a 4-week scheduled period as one cycle of regimen in time-sequence diagram regarding 10/13 (77%) questionnaires. The PNQ concerning sensory/motor disorder also demonstrated a spike pattern and an increase from the baseline as the number of administrations. It is valid and feasible to assess fatigue by FACIT-F questionnaire for patients with URPC undergoing nab-paclitaxel plus gemcitabine therapy, and to detect detailed changes in accordance with scheduled cycles of chemotherapy regimen.