Quality of Life Clinical Trial
Official title:
Thymosin-α1 for Cancer-Related Fatigue in Cancer Patients Who Undergo Chemotherapy: A Randomized Controlled Trial
Cancer-related fatigue (CRF) is a distressing, persistent, subjective sense of physical,
emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatment
that is not proportion to recent activity and interferes with usual functioning. Compared
with general fatigue, CRF have the characteristics of long duration and generally cannot
alleviate by rest or sleep, serious impact on the patient's work, study, entertainment and
family life, and thus greatly affect the recovery, self-care ability and life quality of
patients. Many dates showed that 70%~100% of cancer patients experienced cancer-related
fatigue.For cancer-related fatigue there is no good treatment and intervention, in recent
years, many clinical trials are carried out; central nervous stimulant, such as
methylphenidate; acupuncture, aerobic exercise. All those measures may have certain
therapeutic effect for CRF, but don't have exact evidences from massive RCT to confirm.
Thymosin-α1 (T-α1), a synthetic 28-amino acid peptide with multiple biological activities
primarily directed towards immune response enhancement, this drug is used for the treatment
of HBV and hepatitis C virus (HCV) infections, and being developed for the treatment of
non-small cell lung cancer (NSCLC), hepatocellular carcinoma, AIDS and malignant melanoma.
T-α1 is able to potentiate the action of cytokines and also reduce the hematological toxicity
of cytotoxic drug therapy, such as cyclophosphamide, 5-fluorouracil, dacarbazine.
In this studies, we want to demonstrated that the effectiveness of Thymosin-α1 for
cancer-related fatigue in cancer patients who undergo chemotherapy.
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