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

Abstract

Abstract. 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.

Impact of Ninjin'Yoeito on Fatigue in Patients Receiving Nab-Paclitaxel Plus Gemcitabine Therapy: A Prospective, Single-Arm, Phase II Open Label, Nonrandomized, Historically-Controlled Study

“…We previously demonstrated increase in the mean maximum degree of fatigue from mean baseline values by nab-paclitaxel plus gemcitabine therapy across all categories of the questionnaire. 16 In the present study, the threshold mean of FACIT-F score within 8 weeks of chemotherapy was significantly lower than that of the previous study.…”

“…Results of weekly assessment of fatigue by FACIT-F during the first 2 cycles of consecutive chemotherapy with NYT was compared with results from an identically designed study without NYT. 16 The primary end point of evaluation of fatigue according to FACIT-F was met in the present study. We previously demonstrated increase in the mean maximum degree of fatigue from mean baseline values by nab-paclitaxel plus gemcitabine therapy across all categories of the questionnaire.…”

“…We conducted an observational study to evaluate fatigue and malaise using FACIT-F in patients with URPC after nab-paclitaxel plus gemcitabine therapy. 16 Mean (SD) increase in FACIT-F at 8 weeks after chemotherapy was 5.3 (7.2). In the current trial, we expected the mean of this score to be less than half of that of the previous study.…”

“…1895). We designed 2 studies to evaluate the effect of NYT, an observational study without administration of NYT, 16 then the current interventional study, in which NYT was administered. No patients were enrolled in both studies.…”

“…Balancing subjective and objective assessment of these symptoms is difficult in clinical settings. We previously prospectively assessed the feasibility and validity of patient-based scales in patients with URPC who underwent nab-paclitaxel plus gemcitabine therapy 16 using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire, 17 and the Patient Neurotoxicity Questionnaire (PNQ). 18 The threshold mean of FACIT-F score during chemotherapy was 5.3.…”