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Effect and mechanism of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer: a randomized, double-blind clinical trial

Effect and mechanism of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer: study protocol for a randomized, double-blind clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020107
Enrollment
Unknown
Registered
2018-12-14
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-12-18

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

Conditions

Chemotherapy-induced alopecia

Interventions

Group 1:YH0618 granule
Group 2:Placebo granule

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) females with breast cancer aged between 18-75 years; (2) will receive first chemotherapy; (3) scheduled to receive chemotherapeutic agents containing taxanes or anthracyclines; (4) chemotherapy regimen will last at least 6 cycles and every three weeks is a cycle; (5) adverse events assessed using WHO toxicity classification criteria< II grade; (6) a life expectancy is at least 6 months.

Exclusion criteria

Exclusion criteria: (1) subjects with a medical history of hair transplantation; (2) suffer from psoriasis or severe scalp infection; (3) hair loss induced by alopecia areata, alopecia totalis or scalp injury, etc.; (4) pregnancy, lactation or potential pregnancy; (5) allergic to some specific food, like black soybean, etc.; (6) severe cardiac, hepatic, renal, pulmonary and hematic lesions or other diseases which will affect their survival; (7) who have any severe mental or behavioral disorders that cannot be fully informed; (8) be suspected or do have a history of alcohol and drug abuse, or cannot cooperate with the treatment process; (9) cannot understand or fill in questionnaires because of cognitive disorders or low level of literacy; (10) a variety of factors affecting drug taking and absorption, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.

Design outcomes

Primary

MeasureTime frame
Indexes of hair loss;

Secondary

MeasureTime frame
Assessment of quality of life;blood routine examination;Assessment of hepatic and renal function;

Countries

China

Contacts

Public ContactCHEN Jianping

School of Chinese Medicine, The University of Hong Kong

abchen@hku.hk+852 39176479

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026