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A Pilot Randomized Controlled Trial to Evaluate the Efficacy and Explore the Mechanism of Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer.


N/A
18 Years
N/A
Open (Enrolling)
Both
Mucositis, Oropharyngeal Cancer

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Trial Information

A Pilot Randomized Controlled Trial to Evaluate the Efficacy and Explore the Mechanism of Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer.


This is a single-center, randomized controlled pilot clinical trial (n=20) assessing the
efficacy, feasibility and safety of acupuncture in reducing the severity of
chemoradiation-induced oral mucositis (CRIOM) in patients with oropharyngeal cancer.
Participants will be randomized to receive either usual medical care or acupuncture
treatment plus usual medical care once a week for 8 weeks coinciding with their
chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment
and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16). All
subjects will receive usual medical care in addition to the study intervention. The Oral
Mucositis Daily Questionnaire for Head and Neck Cancer patients (OMDQ) will be used to
assess patients' self-reported chemoradiation-induced mucositis severity at baseline (before
1st acupuncture session), and daily throughout the course of radiation, as well as at the 12
and 16 week follow up visits. At baseline, weekly during radiation therapy, and at the 12
and 16 week follow up appointments, patients will complete the Functional Assessment of
Cancer Therapy (FACT-G), Esophagus Cancer subscale (ESC) QOL, and the Functional Assessment
of Chronic Illness Therapy (FACIT)-Fatigue subscale questionnaires. Oral mucositis will also
be assessed objectively by a trained member of the research team using both the Oral
Mucositis Assessment Scale (OMAS) and the National Cancer Institute- Common Toxicity
Criteria for Adverse Events (NCI-CTCAE) v3.0 measurement scale once a week for the first two
weeks of chemoradiation treatment, then twice a week during weeks three through seven, and
additionally once during week 8 and once at the 12 and 16 week follow up visits. Twice
weekly measurements correspond to peak severity of mucositis during weeks three to seven,
based on previous reports in the literature. Patients will be given a weekly diary to
record oral analgesic intake. Lastly, 8 milliliters of blood and a saliva sample will be
taken from the subjects at baseline (before 1st acupuncture session), weekly through
radiation treatment, and at the week 12 and 16 follow up visits to measure changes in
proinflammatory cytokines concentrations.


Inclusion Criteria:



- Documented diagnosis of oropharyngeal cancer.

- The patient plans on undergoing external beam radiation with concomitant
chemotherapy.

- Eastern Cooperative Group in Oncology (ECOG) performance status 0-3.

- Men and women who are ≥ 18 years old

- The patient is aware of the nature of his or her diagnosis, understands the study
regimen, its requirements, risks, and discomforts, and is able and willing to sign an
informed consent form.

Exclusion Criteria:

- Previous history of head and neck cancer.

- Prior acupuncture within the past month.

- Pre-existing active oral infection

- Life expectancy is < 3 months.

- Plan to go on experimental drug for head and neck cancer in the next 14 weeks.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Side effects of acupuncture treatment

Outcome Description:

All acupuncture side effects will be recorded

Outcome Time Frame:

16 weeks

Safety Issue:

Yes

Principal Investigator

Ting Bao, MD, DABMA

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland Marlene & Stewart Greenebaum Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

HP-00053319

NCT ID:

NCT01883908

Start Date:

December 2012

Completion Date:

February 2015

Related Keywords:

  • Mucositis
  • Oropharyngeal Cancer
  • Acupuncture therapy
  • Mucositis
  • oropharyngeal cancer
  • Oropharyngeal Neoplasms
  • Mucositis

Name

Location

University of Maryland Marlene & Stewart Greenebaum Cancer CenterBaltimore, Maryland  21201