Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-07 @ 6:06 AM
Study NCT ID:
NCT02127268
Status:
UNKNOWN
Last Update Posted:
2019-04-10
First Post:
2014-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thymosin-α1 in Cancer-Related Fatigue
Sponsor:
Zhigang Zhang
Organization:
Study Overview
Official Title:
Thymosin-α1 for Cancer-Related Fatigue in Cancer Patients Who Undergo Chemotherapy: A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: