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Thymosin-α1 in Cancer-Related Fatigue

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StatusMerekrut
Sponsor
Zhigang Zhang

Kata kunci

Abstrak

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.

tanggal

Terakhir Diverifikasi: 03/31/2019
Pertama Dikirim: 04/27/2014
Perkiraan Pendaftaran Telah Dikirim: 04/28/2014
Pertama Diposting: 04/29/2014
Pembaruan Terakhir Dikirim: 04/08/2019
Pembaruan Terakhir Diposting: 04/09/2019
Tanggal Mulai Studi Sebenarnya: 03/31/2014
Perkiraan Tanggal Penyelesaian Utama: 03/31/2020
Perkiraan Tanggal Penyelesaian Studi: 11/30/2020

Kondisi atau penyakit

Cancer Related Fatigue
Quality of Life

Intervensi / pengobatan

Drug: Arm T

Tahap

Tahap 3

Kelompok Lengan

LenganIntervensi / pengobatan
Active Comparator: Arm T
Will be treated with Thymosin-α1 1.6mg twice a week from day 1 of chemotherapy
Drug: Arm T
with Thymosin-α1 1.6mg twice a week
No Intervention: Arm B
With best support according to NCCN Guideline

Kriteria kelayakan

Usia yang Layak untuk Belajar 18 Years Untuk 18 Years
Jenis Kelamin yang Layak untuk BelajarAll
Menerima Relawan SehatIya
Kriteria

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-α1 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.

Hasil

Ukuran Hasil Utama

1. Change in Cancer-Related Fatigue Scale [baseline and 4 weeks]

Ukuran Hasil Sekunder

1. improvement in Quality of Life [baseline and 4 weeks]

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