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A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer


Phase 3
N/A
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Oral Complications of Chemotherapy and Head/Neck Radiation, Radiation Toxicity, Xerostomia

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Trial Information

A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer


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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of head and neck cancer

- Xerostomia grade 2 or 3 due to prior bilateral radiotherapy

- Acupuncture naive

PATIENT CHARACTERISTICS:

- No prior xerostomia

- No infection at or near the acupuncture sites OR active infection

- Ability to speak, read, and understand English

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 9 months since prior radiotherapy

- Chemotherapy during or after radiotherapy allowed

- No concurrent or plan to receive another xerostomia treatment agent

- At least 14 days since prior agents known to treat xerostomia

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

Response to acupuncture intervention

Outcome Description:

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.

Outcome Time Frame:

Baseline to 4 weeks post acupuncture

Safety Issue:

No

Principal Investigator

Lorenzo Cohen, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2010-0547 MDA

NCT ID:

NCT01141231

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Long-term Effects Secondary to Cancer Therapy in Adults
  • Oral Complications of Chemotherapy and Head/Neck Radiation
  • Radiation Toxicity
  • Xerostomia
  • 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
  • Head and Neck Neoplasms
  • Xerostomia
  • Radiation Injuries

Name

Location

CCOP Research Base SitesHouston, Texas  77030