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

Preventive Effect of Nobiletin/Tangeretin Mixture on Lower Urinary Tract Symptoms after Proton Beam Therapy for Prostate Cancer (Randomized, placebo-controlled, double-blind, comparative study) - Not-LUTSaPP Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031220159

Enrollment

104

Registered

2022-06-23

Start date

2023-01-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer Prostate Cancer

Interventions

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 rece

D016032

Randomized, placebo-controlled, double-blind comparison

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Difference in change in International Prostate Symptom Score (IPSS) (before and at the end of proton beam therapy)	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Contacts

Public ContactHiromitsu Negoro

University of Tsukuba Hospital

hnegoro@md.tsukuba.ac.jp+81-29-853-3223

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026