Background: AL is a traditional Chinese medicine (TCM) combination commonly used as an adaptogen to improve energy levels, immunity and quality of life in those suffering from chronic diseases such as cancer. While the combination Astragalus membranaceus and Ligustrum lucidum (AL) has been investigated in China as an adjunct to standard anticancer therapies in numerous clinical studies of variable quality reported in the Chinese literature, independent assessment of its effects on safety, tolerability and efficacy are lacking. Our objectives are to determine the safety and tolerability of AL and investigate its effects on inflammation, quality of life and immunity in people with advanced malignancy in the Australian healthcare setting. Methods: The AL study is a prospectively registered, open labelled pilot multi-centre study investigating AL in people with advanced malignancy. Inclusion criteria include participants with recurrent or metastatic cancer who are not undergoing chemotherapy or palliative chemotherapy. All participants (n=25) will receive 6 capsules of AL twice daily (equivalent to 25g raw herb) for 12 weeks. Follow up consultations will monitor safety, tolerability, quality of life, immune function and adverse events. Participants will be assessed at baseline and at weeks 3, 6, 9 and 12. The primary outcome will determine the effect of AL on safety and tolerability. Secondary outcomes will include inflammation, quality of life, immune function, disease status and survival. Appropriate statistical analysis will be conducted on the pilot study data. Potential associations will be investigated where relevant. Conclusions: This study will firstly establish the safety and tolerability of this TCM combination "AL" in people with advanced malignancy in the Australian healthcare system and provide important information regarding its effect on markers that may affect survival as well as explore changes in quality of life and immune function. The impact of this research may allow the design of future studies integrating AL with standard therapy for people with advanced malignancy.

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Double-hit diffuse large B-cell lymphoma (DHL) is an uncommon subtype of lymphoma which poorly responds to current drug therapies and has low rates of long-term survival in the patients. Herein, we report a case of a 73-year-old Caucasian male who was diagnosed with DHL with double-hit mutations of rearrangement of both c-MYC and BCL2 in November 2013. He commenced the standard R-CHOP-14 chemotherapy (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone) but changed to dose-adjusted DA-EPOCH-R protocol (etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and rituximab) in the second and third cycles due to double-hit mutation. Because of intolerance to the intensive therapy, the patient decided to switch to Chinese medicine intervention. From March 2014 to December 2019, he was prescribed with a classical Chinese herbal formula— Sijunzi Decoction plus Prunella vulgaris based prescriptions. After 2 months of the Chinese herbal medicine intervention, the patient felt his right groin mass disappeared. Imaging follow-up showed no residual masses, and no lymphadenopathy was seen. During the period of Chinese herbal medicine treatment, his adherence and tolerability were well maintained with no adverse events. Imaging surveillances afterward found no evidence of lymphoma recurrence. His regular blood tests indicated that the patient’s blood counts were normal and stable; no hematologic toxicity, hepatoxicity, or nephrotoxicity associated with Chinese herbal medicine were found. Follow-up visits until 2020 found that he had been living and enjoying a good quality of life for over 8 years post-diagnosis. This case study illustrates the potential values of Chinese herbal medicine in DHL treatment, alongside chemo-immunotherapy, and in maintaining long-term survival and satisfactory quality of life for DHL patients. The case report provides clinicians with preliminary evidence of the use of Chinese herbal medicine as a therapeutic strategy in the management of DHL.