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Trial Title:
Effect of Intravesical B.C.G and Gemcitabine on Semen Quality and Testicular Volume
NCT ID:
NCT05701332
Condition:
Urothelial Carcinoma Bladder
Sperm Count, Low
Testis; Fibrosis
Conditions: Official terms:
Urinary Bladder Neoplasms
Oligospermia
Gemcitabine
BCG Vaccine
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Bacillus Calmette Guerin
Description:
effect of local B.C.G and Gemcitabine on semen parametes and testicular volume
Arm group label:
BCG
Other name:
Gemcitabine
Summary:
To evaluate the effects of local intravesical B.C.G and gemcitabine on semen quality and
testicular volume.
Detailed description:
Local chemotherapy has become one of the alternative strategies in treatment of cancer as
many side effects on organs in human body. Despite this, also local chemotherapy has
adverse effects too. One of these cancers in which local chemotherapy is used and one of
the most five prevalent cancers in Egyptian men and the 3rd highest incidence numbers for
specific cancer cases in Egypt in 2020,also It represents the 3rd highest mortality
number from cancer in Egypt by 19% of men's mortality is bladder cancer. It is divided
according to the staging system into 2 main types: the non-muscle invasive (T1) and
muscle invasive (T2).The most common method used to treat T1 baldder cancer are TURT
followed by local intravesical immunotherapy (like Bacillus Calmette Guerin) and
chemotherapy (Gemcitabine and Mitomycin C). These drugs systemically can cause side
effects like urgency, frequency, low grade fever, malaise, effect on high proliferative
tissues like bone marrow, skin, hair, and seminiferous tubules....etc. Some rare side
effects are acute respiratory distress syndrome and hepatic toxicity. The effect of these
drugs on seminiferous tubules is still a controversy as most of the research field is
focusing on systemic use, also the lack of researches focusing on local intravesical use.
It can cause infertility especially in young patients with cancer who seek fertility and
they are not married or not having children. The problem of fertility and urogenital
cancer is multifactorial and there is a gap of knowledge as low incidence number of
bladder cancer in young patients and the lack of he studies focusing on fertility in
cancer patients. This study is going to unmask the mystery of one of local immunotherapy
and immunotherapy and there effect on semen and testicles.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male patients from 20 to 60's year old (the years of reproductive active men)
2. Non muscle invasive bladder (T1 or less) urothelial carcinoma who are elected to
intravesical immunotherapy or chemotherapy after TURT
Exclusion Criteria:
i. T1 carcinomas of bladder in which intravesical immunotherapy and chemotherapy is
contraindicated ii. Patients under conditions that may affect sperm number, e.g. Systemic
chemotherapy, radiotherapy and previous history of genitourinary tuberculosis, Prostatic
carcinoma,...etc iii. Abnormal semen parameters or abnormal hormonal profile
(hypogonadism) that interfere with the study, especially azoospermia and aspermia
Gender:
Male
Gender based:
Yes
Minimum age:
20 Years
Maximum age:
60 Years
Healthy volunteers:
No
Start date:
April 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05701332