A Phase 3 interventional study of Thymosin-α1 in Cancer Related Fatigue and Quality of Life, sponsored by Zhigang Zhang. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-04-10.
Sponsored by Zhigang Zhang · Phase 3, Interventional, and Treatment
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.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's planned enrollment of 200 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →This is the only study on the registry with Zhigang Zhang as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Will be treated with Thymosin-α1 1.6mg twice a week from day 1 of chemotherapy
Drug: Thymosin-α1
With best support according to NCCN Guideline
with Thymosin-α1 1.6mg twice a week
Change in Cancer-Related Fatigue Scale
Time frame: baseline and 4 weeks
improvement in Quality of Life
Time frame: baseline and 4 weeks
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.