Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis

Last updated: September 7, 2021
Sponsor: Chang Gung Memorial Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Mucositis

Human Papilloma Virus (Hpv)

Head And Neck Cancer

Treatment

N/A

Clinical Study ID

NCT05040425
202101231A3
  • Ages 20-75
  • All Genders

Study Summary

This protocol describes a randomized, double-arm, parallel-group, open-label controlled study that aims to evaluate the efficacy of Chinese herbal medicine on head and neck cancer patients with oral mucositis toxicities and quality of life during radiotherapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically proven stage II-IV squamous HNC
  • Indication for radiotherapy or radio-chemotherapy
  • No history of antitumor therapies
  • No history of oral ulcer and salivary gland diseases
  • Normal vital signs (body temperature: 36 to 37.5∘C, heart rate: 60 to 100 beats perminute, respiratory rate: <20 per minute, and mean arterial pressure: 70 to 100mmHg),and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion

Exclusion Criteria:

  • Terminal cancer for which aggressive treatments were not suitable
  • Impaired renal or hepatic function at initial diagnosis (including chronic kidneydisease stages III, IV, and V and Aspartate transaminase (AST), Alanineaminotransferase (ALT) ≥5 × the upper normal limit)
  • Uncontrolled psychiatric problems or altered mental status
  • Had received medications for other clinical trials

Study Design

Total Participants: 200
Study Start date:
August 30, 2021
Estimated Completion Date:
April 01, 2023

Study Description

200 head and neck cancer patients who were scheduled for radiotherapy are randomly assigned at a 1:1 ratio to two arms: control group and those treated with Zi-Yin-Liang-Ge-San containing Rx. Scutellariae, Rx. Glycyrrhizae, Hb. Dendrobii, Rx. Ophiopogonis, and Hb. Menthae Haplocalycis from day 1 of radiotherapy. The study lasted at least 6 weeks and the clinical benefit was determined by onset, gradation of mucositis (Common Terminology Criteria for Adverse Events v5.0), oral pain (visual analysis scale) for each week during RT. Nutritional status, EORTC Quality of Life Core Questionnaire (QLQ-C30) and head and neck module (QLQ-H&N35), Body Constitution Questionnaire (BCQ), and electrical body conductivity were evaluated before and after radiotherapy. Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE), serious adverse events, blood and biochemical analysis will be recorded to evaluate the safety.