NCT05040425

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2 head-and-neck-cancer

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_2 head-and-neck-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

September 10, 2021

Status Verified

August 1, 2021

Enrollment Period

12 months

First QC Date

September 3, 2021

Last Update Submit

September 7, 2021

Conditions

Head and Neck CancerOral Mucositis

Keywords

Oral mucositisRadiotherapyHead and neck cancerChinese herbal medicineRandomized trial

Outcome Measures

Primary Outcomes (2)

  • Degree of oral mucositis

    The degree was graded by the NHI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)

    During the radiotherapy course, up to 6 weeks

  • Mucositis pain

    100-mm-visual analog scale (VAS, 0-100)

    During the radiotherapy course, up to 6 weeks

Secondary Outcomes (3)

  • Health related-QoL (1)

    Baseline, 4th week, and 6th week of radiotherapy completion

  • Health related-QoL (2)

    Baseline, 4th week, and 6th week of radiotherapy completion

  • Body mass index (BMI)

    During the radiotherapy course, up to 6 weeks

Other Outcomes (2)

  • Traditional Chinese medicine constitution

    Baseline, 4th week, and 6th week of radiotherapy completion

  • Electrical body conductivity

    Baseline, 4th week, and 6th week of radiotherapy completion

Study Arms (2)

Chinese herbal medicine treatment

EXPERIMENTAL
Drug: Zi-Yin-Liang-Ge-San

Non-Chinese herbal medicine treatment

NO INTERVENTION

Interventions

Zi-Yin-Liang-Ge-SanDRUG

Zi-Yin-Liang-Ge-San is composed of five herb ingredients, namely Rx. Scutellariae (Huang Qin), Rx. Glycyrrhizae (Gan Cao), Hb. Dendrobii (Shi Hu), Rx. Ophiopogonis (Mai Men Dong), and Hb. Menthae Haplocalycis (Bo He). It is orally administrated trice daily from the first day to the end of RT in the treatment group, aiming to prevent and manage the OM. ZYLGS is manufactured as a concentrated herbal extract, constituted 4 g per packet, and origin from pharmaceutical companies in Taiwan with good manufacturing practice (GMP).

Chinese herbal medicine treatment

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 per minute, respiratory rate: \<20 per minute, and mean arterial pressure: 70 to 100mmHg), and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck NeoplasmsStomatitis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Central Study Contacts

Ming-Yen Tsai, PhD

CONTACT

+886975056534missuriae@yahoo.com.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The participants selected at screening who provide written informed consent will be randomly allocated to two groups. One will be submitted to Chinese herbal medicine group, and the other to control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2021

First Posted

September 10, 2021

Study Start

August 30, 2021

Primary Completion

August 17, 2022

Study Completion

April 1, 2023

Last Updated

September 10, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.