Hepatitis B, Neoplasms
Conditions
Keywords
hepatitis B during cancer chemotherapy
Brief summary
Patients with non-lymphoma and non-leukaemia cancer who are also hepatitis B carriers will have a risk of hepatitis B reactivation during chemotherapy. Lamivudine can be used effectively to control hepatitis upon reactivation during chemotherapy and the chemotherapy may not need to be interrupted. The study aims to investigate whether adding the anti-viral drug Lamivudine at the start of chemotherapy for all patients, rather than at the time of hepatitis reactivation for those with reactivation, will help to improve the delivery of chemotherapy in these patients.
Interventions
DRUGLamivudine
Sponsors
Hospital Authority, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Inclusion criteria
1. Patient with histology-proven malignant solid tumor other than malignant lymphoma 2. Patients with age between 18 and 75 3. Patients with Karnofsky performance score (KPS) of at least 60 4. Patients planned for at least 4 cycles of intensive cytotoxic chemotherapy (either as part of curative therapy or as palliative therapy), except for those receiving single agent cisplatin chemotherapy alone concurrently with radiation for radiosensitization 5. Patients with at least 6 months' life expectany from date of recruitment 6. Patients with normal liver function tests including alanine aminpotransferase (ALT), alkaline phosphatase (ALP), gamma glutamyl-transpeptidase (GGT), and bilirubin 7. Patients with no known history of radiological &/or histological diagnosis of chronic active hepatitis or cirrhosis of any cuase, or history of prior hepatitis B reactivation, or prior chronic therapy for HBV within 6 months 8. Patients with no evidence of autoimmune hepatitis, hepatitis C or delta virus infection, HIV infection or radiological evidence of liver metastasis 9. Patients with negative pregnancy test for female gender of child-bearing age
Exclusion criteria
1. Patients with age \< 18 and \> 75 2. Patients with Karnofsky performance score (KPS) of \< 60 3. Patients planned for single agent cisplatin chemotherapy alone concurrently with radiation for radiosensitization 4. Patients with \< 6 months' life expectancy from date of recruitment 5. Patients with abnormal liver function tests including alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma glutamyl- transpeptidase (GGT), and bilirubin 6. Patients with known history or radiological and/or histological diagnosis of chronic active hepatitis or cirrhosis of any cause, or history of prior hepatitis B reactivation, or prior chronic therapy for HBV within 6 months 7. Patients with autoimmune hepatitis, hepatitis C or delta virus infection, HIV infection or radiological evidence of liver metastasis 8. pregnant female patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of chemotherapy interruptions | during chemotherapy of the study period |
Secondary
| Measure | Time frame |
|---|---|
| incidence of and survival free from hepatitis B reactivation | during and after chemotherapy of the study period |
| HBeAg positive seroconversion and YMDD mutant development rates | during study period after chemotherapy |
| chemotherapy dose intensity reduction due to hepatitis B reactivation | during chemotherapy of the study period |
Countries
China
Outcome results
None listed