Cervical cancer,Endometrial cancer,Vaginal cancer Gynecologic tumor,Cervical cancer,Endometrial cancer,Vaginal cancer
Conditions
Interventions
Administeration of reduced CoQ10 or placebo during definitive radiotherpy for gynecologic tumors (cervical cancer, endometrial cancer, vaginal cancer)
Double-Blind,Reduced CoQ10
Sponsors
Sasaki Ryohei
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Those who are pathologically diagnosed with any of the following gynecologic tumors. Cervical cancer Endometrial cancer Vaginal cancer 2. Those who are scheduled for any of the following treatments. Radiotherapy Postoperative radiotherapy 3. Women who are 20 years of age or older at the time of obtaining consent. 4. Those who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at the time of obtaining consent. 5. Those who can fill out the consent form about participation in this clinical research by themselves.
Exclusion criteria
Exclusion criteria: 1. Those who have active multiple cancers. 2. Those who have a history or complication of scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis. 3. Those who are receiving continuous systemic administration (oral or intravenously) of steroids (prednisolone equivalent 20 mg or more) or immunosuppressive drugs. 4. Those who have received radiotherapy for pelvic tumors in the past. 5. Those who have taken medication for intestinal disorders such as inflammatory bowel disease. 6. Those who are pregnant, may become pregnant, within 28 days after giving birth, or are breastfeeding. 7. Those who are allergic to the ingredients of the test drug. 8. Those who are taking warfarin. 9. Those who take supplements or medicines containing reduced / oxidized CoQ10 as the main ingredient on a daily basis and cannot stop taking them during the entire protocol treatment period. 10. Those who have artificial anus. 11. Those who are judged by the examiner to be inappropriate for participation in the examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum number of increases from the number of normal defecation per day during radiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness Severity of diarrhea (CTCAE ver 5.0) Severity of abdominal pain (CTCAE ver 5.0) Whether or not to take antidiarrheal drugs Days until the start of taking antidiarrheal drugs QOL score (EORTC QLQ-C30, QLQ-CX24) Safety All diseases observed during the protocol period | — |
Contacts
Public ContactSatoshi Seno
Kobe University Hospital
Outcome results
None listed