NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051210039

Registered date:16/06/2021

Evaluation of the Effect of Reduced Coenzyme Q10 (CoQ10) for Reducing Acute Adverse Events During Radiotherapy

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedCervical cancer,Endometrial cancer,Vaginal cancer
Date of first enrollment03/08/2021
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)Administeration of reduced CoQ10 or placebo during definitive radiotherpy for gynecologic tumors (cervical cancer, endometrial cancer, vaginal cancer)

Outcome(s)

Primary OutcomeMaximum number of increases from the number of normal defecation per day during radiotherapy
Secondary OutcomeEffectiveness 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

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderFemale
Include criteria1. 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.
Exclude criteria1. 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.

Related Information

Contact

Public contact
Name Satoshi Seno
Address 7-5-2 Kusunoki-cho,Chuo-ku,Kobe,Hyogo Hyogo Japan 650-0017
Telephone +81-78-382-5687
E-mail ano.senoodesuga@gmail.com
Affiliation Kobe University Hospital
Scientific contact
Name Ryohei Sasaki
Address 7-5-2 Kusunoki-cho,Chuo-ku,Kobe,Hyogo Hyogo Japan 650-0017
Telephone +81-78-382-5687
E-mail rsasaki@med.kobe-u.ac.jp
Affiliation Kobe University Hospital