Effect and Mechanism of YH0618 Granule on Chemotherapy-Induced Hair Loss in Patients with Breast Cancer: Study Protocol for a Randomized, Double-Blind, Multi-Center Clinical Trial
January 2019
in “
Research Square (Research Square)
”
TLDR The trial will test if YH0618 granule prevents hair loss in breast cancer patients during chemotherapy.
The document describes a protocol for a randomized, double-blind, multi-center clinical trial to assess the effectiveness of YH0618 granule, a medicinal and edible decoction, on chemotherapy-induced hair loss in breast cancer patients. The study aims to determine if YH0618 granule can promote hair growth without interfering with the anti-tumor effects of chemotherapy. Breast cancer patients undergoing chemotherapy with Taxanes and/or Anthracyclines will be divided into two groups: one receiving YH0618 granule and the other receiving a placebo. The primary outcome will be hair preservation, assessed by the WHO Toxicity Grading Scale and measurements of hair loss levels, density, and quality. Secondary outcomes will include quality of life, routine blood tests, hepatic and renal function, and indicators of kidney deficiency in Chinese Medicine. The trial was registered on December 14, 2018, at the Chinese Clinical Trial Registry under the identifier ChiCTR1800020107.
