Thymosin-α1 in Cancer-Related Fatigue

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02127268
• Other study ID #: T-CRF
• Status: Recruiting
• Phase: Phase 3
• Start date: April 2014
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: Zhejiang University
• Contact: Zhigang Zhang
• Phone: 8657187315009
• Email: zzg2011[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Men and women aged 18 years and older.

2. The life expectancy at least 6 months.

3. With a definite pathological diagnosis of cancer, and undergo chemotherapy.

4. Patients who are willing to participate in the study.

Exclusion Criteria:

1. Thymosin-a1 allergy.

2. Using the spirit excitement or stimulant drugs.

3. With brain metastasis or primary malignant brain tumors.

4. With mental disorders, such as suffering from dementia, delirium, obsessive-compulsive disorder, schizophrenia, epilepsy.

5. Other specific causes of fatigue: such as anemia, thyroid function is low, insomnia, uncontrolled pain.

6. Serious HRS cardiopulmonary function disorder.

7. Women during pregnancy and lactation.

Related Conditions & MeSH terms

• Cancer Related Fatigue
• Fatigue
• Quality of Life

Intervention

Drug:
• Thymosin-a1
with Thymosin-a1 1.6mg twice a week

Locations

Country	Name	City	State
China	Cancer institute	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhigang Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cancer-Related Fatigue Scale		baseline and 4 weeks
Secondary	improvement in Quality of Life		baseline and 4 weeks