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

NCT06272617 | Recruiting

• 1 other identifier: 2023-960
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Tumor of Head and/or Neck; Radiotherapy; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Salivary flow rate

  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

  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

  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

  1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment

• Oral mucositis

  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

Study Arms (2)

treatment group

EXPERIMENTAL

verum acupuncture

Device: verum acupuncture

control group

SHAM COMPARATOR

sham acupuncture

Device: sham acupuncture

Interventions

verum acupuncture DEVICE

a type of acupuncture which is useful

treatment group

sham acupuncture DEVICE

a type of acupuncture which is useless

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead
• West China Fourth Hospital, Sichuan University: collaborator

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Xingchen Peng

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Xingchen Peng

CONTACT

+8618980606753; pxx2014@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 22, 2024
• Study Start: July 25, 2023
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2025
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

CN (1)