Xerostomia Pilot Fudan: Acupuncture for Prevention of Radiation-Induced Xerostomia

NCT00862550 | Unknown DMC

• 2 other identifiers: 2008-0801NCI-2009-01558
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

PRIMARY AIM

1. 1.Determine the feasibility of providing true and sham acupuncture treatment to patients at Fudan University Cancer Hospital (Cancer Hospital) who are receiving radiation treatment for cancer of the head and/or neck area.
2. 2.Determine if true acupuncture is more effective than sham acupuncture for preventing radiation-induced xerostomia among cancer patients at Cancer Hospital.
3. 3.Determine if true acupuncture is more effective than sham acupuncture for reducing the severity of radiation-induced xerostomia.

Conditions

Head and Neck Cancer; Xerostomia

Keywords

Head and Neck Cancer; HNC; Nasopharyngeal carcinoma; Acupuncture; Radiation-Induced Xerostomia; Xerostomia; Dry Mouth; Radiation

Outcome Measures

Primary Outcomes (1)

• Subject Recruitment (#)

  Feasibility determined by how many eligible patients approached consented to be in the trial and patients' reported satisfaction with the study

  2 Years

Study Arms (2)

Group 1

EXPERIMENTAL

Acupuncture (Areas known to help dry mouth)

Other: Acupuncture

Group 2

EXPERIMENTAL

Acupuncture (Areas not known to help dry mouth)

Other: Acupuncture

Interventions

Acupuncture OTHER

20 Minute Acupuncture Sessions Before Radiation Therapy Treatment, 3 Days Per Week for 7 Weeks.

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• \) Diagnosed with nasopharyngeal carcinoma and scheduled to undergo IMRT
• \) Treatment plan must include treatment at a mean dose of 25 gray or more bilateral to the parotid
• \) Must have anatomically intact parotid and submandibular glands
• \) Karnofsky Performance Status \> 60
• \) If the participant is female and of child bearing potential, must have a negative urine pregnancy test. (Acupuncture should be used cautiously during pregnancy since some points have been shown to stimulate uterine contractions

You may not qualify if:

• History of xerostomia prior to the head and neck radiation therapy (Sjögren's disease or other underlying systemic illness known to cause xerostomia).
• Prior head and neck radiation treatment
• Suspected or confirmed physical closure of salivary gland ducts on either side
• Known bleeding disorders or on Heparin or Coumadin
• Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory
• Local skin infections at or near the acupuncture site or active systemic infection
• History of cerebrovascular accident or spinal cord injury. (The mechanism of action for acupuncture may be associated with central nervous system (CNS) activity, and patients with CNS pathology may respond differently to treatment than the general population.)
• Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry as these patients may not be able to cooperate with this slightly invasive procedure or with the data collection process
• Current acknowledged use of any illicit drugs or evidence of alcohol abuse as defined by The American Psychiatric Association criteria
• Participants who are taking or who have taken any investigational new drug within the last 30 days, or who are planning to take such a drug during the course of the study
• Current acknowledged use of other alternative medicines such as herbal preparations that could affect salivary function. Each patient will be asked for a list of herbal supplements they are currently taking and this will be reviewed on an individual basis. Patients will be excluded if they are taking any herbs known or suspected to affect salivary function
• Participants taking amifostine, cholinergic agonist medication (Pilocarpine, Cevimeline), beta adrenergic antagonists, anticholinergic agents, saliva substitutes or other medications known to affect salivary function
• Currently receiving acupuncture for any condition
• Prior use of acupuncture

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, China

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Head and Neck Neoplasms; Xerostomia; Nasopharyngeal Carcinoma

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Joseph S. Chiang, MD, MS, BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 17, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2022
• Last Updated: December 30, 2020

Record last verified: 2020-12

Locations

CN (1)