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Acupuncture in Treating Dry Mouth Caused By Radiation Therapy in Patients With Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01141231
First received: June 9, 2010
Last updated: May 15, 2017
Last verified: May 2017
  Purpose

RATIONALE: Acupuncture may help relieve dry mouth caused by radiation therapy.

PURPOSE: This randomized phase III trial is studying to see how well one set of acupuncture points work in comparison to a different set of acupuncture points or standard therapy in treating dry mouth caused by radiation therapy in patients with head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer Long-term Effects Secondary to Cancer Therapy in Adults Oral Complications of Chemotherapy and Head/Neck Radiation Radiation Toxicity Xerostomia Procedure: Acupuncture Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response to acupuncture intervention [ Time Frame: Baseline to 4 weeks post acupuncture ]
    Xerostomia Questionnaire score before and 4 weeks after starting acupuncture. The Xerostomia Questionnaire is an 8-item survey with each item scored between 0 and 10 then the final score normalized to a 0-100 scale. High score of 10 = increased severity of xerostomia.


Secondary Outcome Measures:
  • Duration of response to a maximum of 6 months [ Time Frame: Baseline to 6 Months ]
    Duration of response assessed by determining Xerostomia Questionnaire scores at 8 and 12 weeks and the 6 month follow-up.


Estimated Enrollment: 240
Actual Study Start Date: November 2012
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Care
Standard oral hygiene care for 8 weeks, including instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice.
Active Comparator: Acupuncture Group 1
Acupuncture at 3 sites on each ear, on the chin, on each forearm, and on each leg twice a week for 4 weeks; and standard oral hygiene as in standard of care arm.
Procedure: Acupuncture
Patients undergo acupuncture twice weekly for 4 weeks
Active Comparator: Acupuncture Group 2
Acupuncture twice a week for 4 weeks and standard oral hygiene as in standard of care arm.
Procedure: Acupuncture
Patients undergo acupuncture twice weekly for 4 weeks

Detailed Description:

OBJECTIVES:

Primary

  • To determine whether acupuncture can symptomatically improve moderate or severe radiation-induced xerostomia (grade 2 or 3) in patients with head and neck cancer.

Secondary

  • To explore the duration of response (up to a maximum of 6 months) in the subgroup of patients who report a response to the acupuncture intervention.

OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease, age, sex, the mean of parotid radiotherapy doses received, and baseline Xerostomia Questionnaire (XQ) scores. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive standard oral hygiene care for 8 weeks, including instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice.
  • Arm II: Patients receive acupuncture at 3 sites on each ear, on the chin, on each forearm, and on each leg twice a week for 4 weeks. Patients with minor response may continue treatment for an additional 4 weeks. Patients also receive standard oral hygiene as in arm 1.
  • Arm III: Patients receive acupuncture twice a week for 4 weeks and standard oral hygiene as in arm 1. Patients with minor response may continue treatment for an additional 4 weeks.

Patients complete XQ, the M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN), and the Functional Assessment of Cancer Therapy (FACT-G) questionnaires at baseline and at the end of weeks 4, 8, and12. Patients with partial response or minor response, according to week-8 questionnaires, complete XQ, MDASI-HN, and the FACT-G at the end of week 12 and at 6 months. Patients in group 2 and 3 also complete the Acupuncture Expectancy Scale (AES). Saliva is also collected at these time points.

  • Coordinating Center: The University of Texas MD Anderson Cancer Center Community Clinical Oncology Program (CCOP) Research Base
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be at least 18 years of age and able to give informed consent.
  2. Must have a diagnosis of head/neck cancer.
  3. Must have received bilateral radiation therapy, and subsequently developed grade 2 or 3 xerostomia, according to RTOG scale: Grade 0 - None Grade 1 - Slight dryness of mouth, good response on stimulation Grade 2 - Moderate dryness of mouth, poor response on stimulation Grade 3 - Complete dryness of mouth, no response on stimulation Grade 4 - Fibrosis
  4. Must have received external beam radiation at a mean dose of at least 25 Gy to one of the parotid glands. The other gland can receive less than 25 Gy. (Chemotherapy during or subsequent to radiation therapy is allowed).
  5. Must have completed radiotherapy at least 12 months prior to entry. Note: Patients currently receiving radiation therapy not involving radiation to the head and neck may be eligible to participate in this trial.
  6. Must have anatomically intact parotid and submandibular glands.
  7. Must be acupuncture naïve.
  8. Must not have any history of xerostomia prior to radiation therapy.
  9. No active infection.
  10. Must have Karnofsky performance status >/= 60 or ECOG performance status of 0-2.

Exclusion Criteria:

  1. History of xerostomia, Sjogren's disease or other illness known to affect salivation prior to head/neck radiation.
  2. Suspected or confirmed closure of salivary gland ducts on either side.
  3. Currently receiving or planning to use receive other xerostomia treatment, including drugs, herbs, alternative medicines, or devices that could affect salivary production. All other tTreatments known to affect salivation should be stopped at least 14 days prior to enrollment. Over the counter products used for salivary substitution are allowed, but will need to be discontinued for at least 24 hours prior to saliva and questionnaire data collection.
  4. Have received any investigational new drug within the past 30 days or planning to receive such during the study period.
  5. Previous acupuncture treatment.
  6. Active systemic infection or skin infection at or near the acupuncture sites.
  7. History of xerostomia prior to the head/neck radiation therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141231

Locations
United States, Texas
CCOP Research Base Sites
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Lorenzo Cohen, PhD M.D. Anderson Cancer Center
Study Chair: Mark S. Chambers, DMD, MS M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01141231     History of Changes
Other Study ID Numbers: 2010-0547 MDA
MDA-04-01
CDR0000674208 ( Other Identifier: NCI Clinical Trials )
2010-0547 ( Other Identifier: MD Anderson Cancer Center )
NCI-2011-02073 ( Registry Identifier: NCI CTRP )
U10 ( Other Grant/Funding Number: CCOP Grant )
CA160880 ( Other Grant/Funding Number: NCI )
Study First Received: June 9, 2010
Last Updated: May 15, 2017

Keywords provided by M.D. Anderson Cancer Center:
hypopharyngeal cancer
laryngeal cancer
lip and oral cavity cancer
nasopharyngeal cancer
oropharyngeal cancer
paranasal sinus and nasal cavity cancer
salivary gland cancer
radiation toxicity
xerostomia
long-term effects of cancer treatment
oral complications of radiation therapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Xerostomia
Radiation Injuries
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on September 21, 2017