Acupuncture for Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer

A Single-center, Single-blind Phase II Clinical Trial of Acupuncture for the Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Malignant Tumors

A study on the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors

Study Overview

• Status: Recruiting
• Conditions: Radiotherapy; Complications; Malignant Tumor of Head and/or Neck
• Intervention / Treatment: Device: verum acupuncture; Device: sham acupuncture

Detailed Description

The goal of this clinical trial is to investigate the efficacy and safety of acupuncture for oral-related complications in patients with head and neck malignant tumors who receive radiotherapy. The main questions it aims to answer are:

• the efficacy of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
• the safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors

Participants will:

• be treated with real acupuncture or sham acupuncture
• be evaluated to learn the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors

Researchers will compare real acupuncture group with sham acupuncture group to see if acupuncture has good efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors.

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xingchen Peng; Phone Number: +8618980606753; Email: pxx2014@scu.edu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital, Sichuan University
      • Contact: Xingchen Peng; Phone Number: 0086-18980606753; Email: pxx2014@scu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with malignant tumors of the head and neck without metastasis
• Age ≥18, ≤80 years old
• ZPS score ≤2
• Receiving radiotherapy alone or concurrent radiotherapy with a radiation dose of >50 Gy, including at least one parotid gland
• Judged to be able to receive acupuncture treatment, with all needle positions identified as accessible
• Signed informed consent form

Exclusion Criteria:

• History of dry mouth, Sjogren's syndrome, or other underlying systemic condition known to cause dry mouth
• Suspected or confirmed physical closure of both salivary gland ducts
• Have a phobia of needles or prohibit the use of acupuncture at any acupuncture points
• Have a history of head and neck radiotherapy
• Have contraindications to acupuncture, including but not limited to bleeding disorders, having skin infections, ulcers or frequent infections
• Have taken any medications or herbs within the past 30 days that may affect salivary function, plan to or eventually take such substances during the study period
• Poor oral hygiene or severe periodontitis
• Poor compliance
• Other patients who, in the opinion of the investigator, are not suitable for participation in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; verum acupuncture	Device: verum acupuncture; a type of acupuncture which is useful
Sham Comparator: control group; sham acupuncture	Device: sham acupuncture; a type of acupuncture which is useless

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Xerostomia questionnaire scores	Patients self-evaluated xerostomia according to Xerostomia questionnaire(score 0-100);Higher score indicates more severe symptoms	1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary flow rate	Researchers-measured unstimulated and stimulated salivary flow rates;Lower value indicates more severe symptoms	1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Taste function assessed by patients	Assessed by Patients self-evaluated dysgeusia(score 19-95);Higher score indicates more severe symptoms	1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Taste function assessed by electrogustometer test	Assessed by electrogustometer test(score -6 to 34);Higher score indicates more severe symptoms	1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Taste function assessed by taste strips test	Assessed by taste strips test(score 0-16);Lower score indicates more severe symptoms	1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Oral mucositis	Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale(grade 1-5);Higher grade indicates more severe symptoms	1 week before radiotherapy;twice a week during the treatment(usually every 3 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Dysphagia	Dysphagia is assessed by M.D.Anderson Dysphagia Inventory(score 20-100);Lower score indicates more severe symptoms	1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Quality of Life assessed by EORTC QLQ-C30	Quality of Life is assessed by EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire);transformed into 0-100 scales for different domains and symptoms;Higher domain scores represent better quality of life, while higher symptom scores represent worse quality of life	1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Quality of Life assessed by QLQ-H&N35	Quality of Life is assessed by QLQ-H&N35(Head and neck cancer-related quality of life scale);transformed into 0-100 scales for different domains and symptoms;Higher scores represent worse quality of life	1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Adverse effects	Assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version(grade 1-5);Higher grade indicates more severe symptoms	up to 12 months
Changes of oral flora	The changes of oral flora in patients' salivary or oral swab measured by 16s rDNA technique	1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Tongue range of motion	Assessed by Tongue Range of Motion Assessment Scale(score 0-100);Lower score indicates more severe symptoms	1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Neck Fibrosis	Assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version:Fibrosis skin(grade 1-5);Higher grade indicates more severe symptoms	1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment

Collaborators and Investigators

• Sponsor: West China Hospital
• Collaborators: West China Fourth Hospital, Sichuan University
• Investigators: Study Director: Xingchen Peng, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Estimated): July 24, 2024
• Study Completion (Estimated): July 24, 2025

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Estimated): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 2023-960

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No