Preventive Effect of Nobiletin/Tangeretin Mixture on Urinary Symptoms after Proton Beam Therapy for Prostate Cancer

JRCT ID: jRCTs031220159

Registered date:23/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostate Cancer
• Date of first enrollment: 17/01/2023
• Target sample size: 104
• Study type: Interventional

Intervention(s)

PMF90 50 mg (containing 35 mg nobiletin and 7 mg tangeretin) plus 150 mg dextrin in a study capsule taken 3 times a day after meals for the duration of proton beam therapy.
The control group will receive 200 mg of dextrin plus lactose and silicon dioxide in a placebo taken in the same manner.

Outcome(s)

• Primary Outcome: Difference in change in International Prostate Symptom Score (IPSS) (before and at the end of proton beam therapy)

Secondary Outcome

Difference in change in IPSS-QOL change (before and at the end of proton beam)
Difference in the amount of change in IPSS subscores
Difference in change in the Athens Insomnia Scale (before and at the end of proton beam)
Safety (the incidence of all disease and other adverse events that occurred after the start of administration of the study food will be included, and the proportion of such events by content will be tabulated)
Degree of dermatitis (refer to RD grading ATLAS)
Patient Global Impression of Change (PGI-C)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 85age old
• Gender: Male

Include criteria

1) Patients with histologically diagnosed primary prostate cancer without metastasis who will receive radical proton therapy.
2) Patients with an ECOG Performance Status of 0-2 who have no other serious diseases.
3) Patients who are equal or more than 40 and less than 85 years of age at the time of consent.
4) Patients who have been fully informed of the study and who have given written consent of their own free will.

Exclude criteria

1) Patients with indwelling urinary catheter
2) Patients with a total IPSS score of 28 or more points
3) Patients with shellfish allergy
4) Patients with poorly controlled diabetes mellitus (casual blood glucose level >= 300 mg/dL or HbA1c >= 8.5%)
5) Patients with serious liver disease (AST (GOT) or ALT (GPT) >= 100 U/L)
6) Patients with serious renal disease (BUN >= 30 mg/dL or serum creatinine >= 2.0 mg/dL)
7) Patients with active urinary tract infection within 1 month prior to proton beam therapy for prostate cancer
8) Patients taking high-concentration nobiletin-containing supplements (Nobilex PMF90, Nobilink EX, Nobiletin Amino Plus, Shikwasa capsules, etc.) within 3 months prior to the start of study capsule administration
9) Other patients who are judged to be inappropriate as subjects by the principal (or sub)investigator

Related Information

• Primary Sponsor: Negoro Hiromitsu
• Secondary Sponsor: Nishiyama Hiroyuki
• Source(s) of Monetary Support: University of Tsukuba Hospital,Donation "DLMM0002K" (for Education and Research in Department of Urology)