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

Phase 2

Recruiting

• Conditions: Cervical cancer,Endometrial cancer,Vaginal cancer; Gynecologic tumor,Cervical cancer,Endometrial cancer,Vaginal cancer; D002583,D016889,D014625

• Registration Number: JPRN-jRCTs051210039
• Lead Sponsor: Sasaki Ryohei

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-16
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum number of increases from the number of normal defecation per day during radiotherapy

Secondary Outcome Measures

Name	Time	Method
Effectiveness<br> Severity of diarrhea (CTCAE ver 5.0)<br> Severity of abdominal pain (CTCAE ver 5.0)<br> Whether or not to take antidiarrheal drugs<br> Days until the start of taking antidiarrheal drugs<br> QOL score (EORTC QLQ-C30, QLQ-CX24)<br>Safety<br> All diseases observed during the protocol period