Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer (GCC1229)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Maryland
Sponsor:
Information provided by (Responsible Party):
Ting Bao, University of Maryland
ClinicalTrials.gov Identifier:
NCT01883908
First received: March 13, 2013
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

Patients are asked to be in this study if have oropharyngeal cancer and will be treated with chemotherapy and radiation.

This research is being done to find out if acupuncture can reduce the mouth inflammation and pain caused by chemotherapy and radiation. Chemoradiation may cause mouth inflammation and pain.

Acupuncture is a medical technique of inserting very thin needles into the "energy points" on the body with the aim to restore health and well-being. It has been used widely to treat pain, such as lower back pain and joint pain. In this study we will assess the potential usefulness of acupuncture to decrease the severity of mucositis and mucositis-related mouth and throat pain in patients receiving chemoradiation for oropharyngeal cancer.

Mouth cancer patients receiving chemoradiation who have not had acupuncture within the last one month and who do not have a history of head and neck cancer may join this pilot study.


Condition Intervention
Mucositis
Oropharyngeal Cancer
Device: Acupuncture with Seirin® needles
Other: Usual medical care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Side effects of acupuncture treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    All acupuncture side effects will be recorded

  • Number of patients completing acupuncture treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Feasibility is defined as greater than 80% patients in the trial completing at least 4 acupuncture sessions.


Secondary Outcome Measures:
  • Change in severity of chemoradiation induced oral mucositis [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Change in severity of chemoradiation-induced oral mucositis (CRIOM) after 8 weeks of acupuncture in patients with oropharyngeal cancer as measured by the patient measured by the area under the curve (AUC) for the peak mouth and throat soreness (MTS) subscale

  • Incidence of oral mucositis according to NCI-CTCAE v3.0 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Incidence of oral mucositis as assessed by the investigators according NCI-CTCAE v3.0 after 8 weeks

  • Incidence of mucositis as measured by the Oral Mucositis Assessment Scale (OMAS) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Incidence of severe oral mucositis as measured by the OMAS after 8 weeks

  • Change in quality of life according to the FACT-G [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    Change in quality of life in head and neck cancer patients undergoing chemoradiation therapy as measured by the Functional Assessment of Cancer Therapy (FACT-G) ESC QoL after 16 weeks

  • Change in quality of life according to the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    Change in quality of life as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale over 16 weeks

  • Changes in serum and saliva proinflammatory cytokine concentrations [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    Changes in concentration of proinflammatory cytokines in serum and saliva over the 16 weeks in two groups.

  • Frequency of oral analgesic use [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    Association of acupuncture with frequency of oral analgesic use in patients with CRIOM

  • Area under the curve (AUC) for the peak mouth and throat soreness (MTS) subscale of the Oral Mucositis Daily Questionnaire (OMDQ) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Severity of chemoradiation-induced oral mucositis (CRIOM) after 8 weeks of acupuncture in patients with oropharyngeal cancer as measured by the patient reported MTS subscale of the OMDQ.

  • Incidence of oral mucositis as assessed by the investigators according to the NCI-CTCAE v3.0 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Incidence of severe oral mucositis according to the NCI-CTCAE v3.0 after 8 weeks of acupuncture


Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture with Seirin® needles
Participants will be randomized to receive 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).
Device: Acupuncture with Seirin® needles
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).
Other: Usual medical care
usual medical care such as viscous Lidocaine for relief of pain
Active Comparator: Usual medical care
Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.
Other: Usual medical care
usual medical care such as viscous Lidocaine for relief of pain

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01883908

Contacts
Contact: James Primrose, RN 410-328-4827 jprimrose@umm.edu
Contact: Michelle Medeiros 410-328-1160 mmedieros@umm.edu

Locations
United States, Maryland
University of Maryland Marlene & Stewart Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Ting Bao, MD, DABMA University of Maryland Marlene & Stewart Greenebaum Cancer Center
  More Information

No publications provided

Responsible Party: Ting Bao, Assistant Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01883908     History of Changes
Other Study ID Numbers: HP-00053319, GCC1229
Study First Received: March 13, 2013
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Acupuncture therapy
Mucositis
oropharyngeal cancer

Additional relevant MeSH terms:
Oropharyngeal Neoplasms
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on October 01, 2014