Thymosin-α1 in Cancer-Related Fatigue

Study Overview
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Brief Summary
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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.

Official Title
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Thymosin-α1 for Cancer-Related Fatigue in Cancer Patients Who Undergo Chemotherapy: A Randomized Controlled Trial

Conditions
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Cancer Related Fatigue, Quality of Life

Intervention / Treatment
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* Drug: Thymosin-α1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 18 years and older. The life expectancy at least 6 months. With a definite pathological diagnosis of cancer, and undergo chemotherapy. Patients who are willing to participate in the study. Exclusion Criteria: Thymosin-α1 allergy. Using the spirit excitement or stimulant drugs. With brain metastasis or primary malignant brain tumors. With mental disorders, such as suffering from dementia, delirium, obsessive-compulsive disorder, schizophrenia, epilepsy. Other specific causes of fatigue: such as anemia, thyroid function is low, insomnia, uncontrolled pain. Serious HRS cardiopulmonary function disorder. Women during pregnancy and lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm T<br>Will be treated with Thymosin-α1 1.6mg twice a week from day 1 of chemotherapy | Drug: Thymosin-α1<br>* with Thymosin-α1 1.6mg twice a week<br>|
| No Intervention: Arm B<br>With best support according to NCCN Guideline | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cancer-Related Fatigue Scale |  | baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in Quality of Life |  | baseline and 4 weeks |