Thymosin-α1 in Cancer-Related Fatigue

NCT02127268 | Unknown Phase 3 DMC

• 1 other identifier: T-CRF
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Related Fatigue; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in Cancer-Related Fatigue Scale

  baseline and 4 weeks

Secondary Outcomes (1)

• improvement in Quality of Life

  baseline and 4 weeks

Study Arms (2)

Arm T

ACTIVE COMPARATOR

Will be treated with Thymosin-α1 1.6mg twice a week from day 1 of chemotherapy

Drug: Thymosin-α1

Arm B

NO INTERVENTION

With best support according to NCCN Guideline

Interventions

Thymosin-α1 DRUG

with Thymosin-α1 1.6mg twice a week

Arm T

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhigang Zhang: lead

Study Sites (1)

Cancer institute

Hangzhou, Zhejiang, 310009, China

RECRUITING

Study Officials

• Jian Huang, Doctor

  Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Zhigang Zhang

CONTACT

8657187315009; zzg2011@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: April 30, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

CN (1)