Granulocyte Colony-Stimulating Factor (G-CSF) Levels in a Randomized, Controlled Acupuncture Trial for Chemotherapy-Induced Neutropenia.

Purpose Ovarian cancer is the most lethal gynecologic cancer. Chemotherapy, the standard of care, has hematologic toxicity, primarily neutropenia. G-CSF is currently used to support white blood cell (WBC) and absolute neutrophil counts (ANC). Prior clinical trials from China suggest that acupuncture could ameliorate chemotherapy-induced leukopenia; the proposed mechanism is an increase in G-CSF levels. In the current study, we investigated the effect of acupuncture, administered during myelosuppressive therapy, on WBC and ANC counts in ovarian cancer patients. Patients and methods Twenty-one newly diagnosed or recurrent ovarian cancer patients were randomized to receive active versus sham acupuncture while undergoing standard IV platinum and taxane-containing chemotherapy. A standardized protocol with 9 acupuncture points was employed with manual and electroacupuncture stimulation. The frequency of acupuncture treatment was 2–3 times per week for a total of 10 sessions, starting 1 week before the 2nd cycle of chemotherapy. WBC and ANC counts were checked weekly at five time points. Serum G-CSF was collected four times during the study. Results Of 587 patients screened, 21 patients were enrolled and received either acupuncture or sham treatment. Patients in both the active and control arms had similar patient characteristics and treatment. Both median WBC and ANC values at nadir in the acupuncture arm were higher than in the control arm, but the differences were not statistically significant, after adjusting for the baseline difference. However, the median WBC in the acupuncture arm at recovery was statistically significantly higher than the control arm, after adjustment (8,600 cell/μL, range: 4,800–12,000 vs. 4,400 cell/μL range: 2,300–10,000) (p=0.045). The recovering median ANC in the patients receiving acupuncture also was higher, but this difference was not statistically significant (p=0.094). The median serum G-CSF at baseline for patients in the active vs. control arm was similar (37.3 pg/mL, range 28.6–393.3 vs. 32.0, range 11.8–211.3, respectively) (p=0.291). At the second time point, the 1st day of the 2nd cycle, the acupuncture group had a higher G-CSF value than the control group (p=0.121). At nadir, the acupuncture group still had a slightly higher G-CSF value than in the control group (p=0.796). However, at the recovery day, the 1st day of 3rd cycle, the G-CSF value in the acupuncture group was lower than in the control arm (p=0.729). No statistical significance in G-CSF value was found at each time point between the two groups. Conclusion The acupuncture protocol used in this study was feasible and safe. We report trends of higher WBC and ANC values during one cycle of myelosuppressive chemotherapy in ovarian cancer patients, suggesting a potential myeloprotective effect of acupuncture. However, current data do not support an acupuncture effect on G-CSF production. These findings warrant a larger study to explore the observed clinical trends and other potential underlying mechanisms.