Acupuncture for Prevention of Radiation-Induced Xerostomia

NCT00430378 | Completed DMC

• 3 other identifiers: 2006-0763NCI-2012-02115U19CA121503
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if acupuncture is effective in preventing xerostomia (dry mouth) in cancer patients who receive radiation treatment to the head and neck area. Researchers also want to learn whether acupuncture lowers the severity of dry mouth that is experienced by these patients. Primary Objective:

• Investigate if acupuncture is effective in preventing xerostomia among cancer patients at Fudan University Cancer Hospital (Cancer Hospital) who receive radiation treatment to the head and neck area. Secondary Objectives:
• Determine whether acupuncture reduces the severity of xerostomia.
• Determine the feasibility of providing acupuncture treatment to patients at Cancer Hospital who are receiving radiation treatment for cancer of the head and/or neck area.

Conditions

Xerostomia; Mouth Dryness; Nasopharyngeal Cancer

Keywords

Xerostomia; Dry Mouth; Mouth Dryness; Nasopharyngeal Cancer; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Xerostomia

  Severity of the xerostomia in both groups compared by testing for group differences in xerostomia scores between baseline and week 7 using a two-sample (unpaired) t test. Repeated measures analyses used in order to detect overall differences in severity over time, differences between groups and the interaction between time and group.

  Baseline + 8 additional points in time (baseline, weeks1-7, week 11).

Study Arms (2)

Acupuncture

EXPERIMENTAL

Acupuncture Before the Radiation Treatment

Procedure: Acupuncture

Standard Care

EXPERIMENTAL

Standard Care Without Acupuncture

Other: Standard Care

Interventions

Acupuncture PROCEDURE

Acupuncture for 20 minutes before the radiation therapy session, 3 days a week for 7 weeks.

Acupuncture

Standard Care OTHER

No Acupuncture.

Standard Care

Eligibility Criteria

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

You may qualify if:

• Adult \>/= 18 year of age and able to sign informed consent
• Diagnosed with nasopharyngeal carcinoma and scheduled to undergo concurrent chemotherapy and radiation treatment
• Treatment plan must include treatment of at least 50 gray 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.

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).
• Planned IMRT
• Suspected or confirmed physical closure of salivary gland ducts on either side
• Known bleeding disorders and 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 cholinergic agonist medication (Pilocarpine, Cevimeline), beta adrenergic antagonists, anticholinergic agents or other medications known to affect salivary function
• Currently receiving acupuncture for any condition
• No prior head and neck radiation treatment

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, China

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Xerostomia; Nasopharyngeal Neoplasms

Interventions

Acupuncture Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Joseph S. Chiang, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: February 1, 2007
• Study Start: January 1, 2007
• Primary Completion: May 27, 2021
• Study Completion: May 27, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

CN (1)