Double-Blind , Placebo-Controlled Randomized Phase II Study of Hangeshashinto for Prevention of Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy (HANGESHA-C Study).

Double-Blind , Placebo-Controlled Randomized Phase II Study of Hangeshashinto for Prevention of Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy (HANGESHA-C Study). - Placebo-Controlled RPII Study of Hangeshashinto for Prevention of Oral Mucositis in CRC Pts Receiving Chemotherapy(HANGESHA-C Study).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004287

Enrollment

Registered

2010-10-01

Start date

2010-10-01

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

Colorectal Cancer

Interventions

Oral administration of Hangeshashinto 7.5g/day t.i.d. after meals. Oral administration of Placebo 7.5g/day t.i.d. after meals.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Receiving chemotherapy. (2)Oral mucositis in previous chemotherapy course. (3)ECOG P.S. of 0 or 1. (4)age of 20 years or older. (5)A life expectancy of more than 12 weeks. (6)Adequate function of vital organs, laboratory data within 7 days. WBC >=3,000/mm3 and <=12,000mm3. Neutrophil >=1,500/mm3 platelet >=100,000/mm3 AST and ALT <=2.5 ULN or <=5.0 ULN if the patient has liver metastasis aspartate aminotransferase and alanine T-Bil <=1.5 ULN Cr <=UNL (7)Written informed consent.

Exclusion criteria

Exclusion criteria: (1)blood transfusion or hemopoietic factors (e.g.G-CSF) within 7 days . (2)Not using traditional Japanese medicines (Kampo) within 2 weeks. (3)Serious drug allergy.. (4)Current analgesic treatment. (5)Neuropathy or sensory dysfunction. (6)Active double cancer. (7)Uncontrolled pleural effusion or ascites. (8)Clinically significant infection. (9)Brain metastasis. (10)Clinically significant electrocardiographic abnormality. (11)Clinically significant heart disease (myocardial infarction within 12 months, etc.). (12)Clinically significant pulmonary disease (13)Gastrointestinal bleeding that requires medication or transfusion. (14)Watery diarrhea.. (15)Myelosuppresion. (16)Ileus or bowel obstruction. (17)Central nervous system disorders. (18)Dementia. (19)Serious psychological disease. (20)Uncontrolled diabetes mellitus with or without diabetic neuropathy.

Design outcomes

Primary

Measure	Time frame
Incidence of oral mucositis. grade>=2	—

Countries

Japan

Contacts

Public ContactChigusa Abe

Epidemiological and Clinical research Information Network (ECRIN) Data Center

chigusa.abe@ecrin.or.jp075-762-1227

Outcome results

None listed

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