To observe the clinical effect of Jianpi Shengxue granule in the treatment of cancer-related fatigue of patients with the syndrome of both qi and blood deficiency.Methods:Sixty-four patients with cancer-related fatigue(syndrome of both qi and blood deficiency) treated in the Department of Traditional Chinese Medicine,Renmin Hospital of Wuhan University from September to December in 2021 were randomized into 2 groups,with 32 patients in each group.The control group received non-medicine therapy(exercise,psychological and nutritional counseling,and guidance for sleep).The observation group received Jianpi Shengxue Granules in addition to the therapy of the control group.The treatment lasted for 30 days.The Piper Fatigue Scale(PFS) scores,Karnofsky Performance Scale(KPS) scores,Pittsburgh Sleep Quality Index(PSQI) scores,the scores and efficacy for TCM syndromes,blood routine indicators,and adverse reactions in the two groups were observed before and after treatment.Results:1) Five patients dropped out during the treatment,and 59 patients completed the whole course of treatment.2) The PFS score after treatment decreased compared with that before treatment(P<0.05),and it was lower in the observation group than in the control group(P<0.05).3) The KPS score after treatment increased compared with that before treatment(P<0.05),and it was higher in the observation group than in the control group(P<0.05).4) The PSQI score after treatment decreased compared with that before treatment(P<0.05),and it was lower in the observation group than in the control group(P<0.05).5) The TCM syndrome scores after treatment decreased compared with those before treatment(P<0.05),and they were lower in the observation group than in the control group(P<0.05).The observation group had higher effective rate on TCM syndromes than the control group(P<0.05).6) The blood routine indicators in the control group showed no significant changes before and after treatment(P>0.05),while those in the observation group elevated after treatment(P<0.05).7) During the treatment period,no adverse reactions associated with Jianpi Shengxue Granules occurred.Conclusion:Jianpi Shengxue Granules has therapeutic effect on cancer-related fatigue in the patients with syndrome of both qi and blood deficiency.