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

NCT01883908 | Terminated Results DMC

• 2 other identifiers: HP-00053319GCC1229
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mucositis; Oropharyngeal Cancer

Keywords

Acupuncture therapy; Mucositis; oropharyngeal cancer

Outcome Measures

Primary Outcomes (2)

• Side Effects of Acupuncture Treatment

  All acupuncture side effects will be recorded

  16 weeks

• Number of Patients Completing Acupuncture Treatment

  Feasibility is defined as greater than 80% patients in the trial completing at least 4 acupuncture sessions.

  16 weeks

Study Arms (2)

Acupuncture with Seirin® needles

EXPERIMENTAL

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; Other: Usual medical care

Usual medical care

ACTIVE COMPARATOR

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

Interventions

Acupuncture with Seirin® needles DEVICE

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).

Acupuncture with Seirin® needles

Usual medical care OTHER

usual medical care such as viscous Lidocaine for relief of pain

Acupuncture with Seirin® needles; Usual medical care

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Marlene & Stewart Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Mucositis; Oropharyngeal Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Limitations and Caveats

The PI left the institution before the end of the study; therefore the study was withdrawn in clinicaltrials.gov and IRB closed.

Results Point of Contact

• Title: Michelle Medeiros
• Organization: University of Maryland Baltimore Greenebaum Cancer Center

mmedeiros@umm.edu

410-328-1160

Study Officials

• Ting Bao, MD, DABMA

  University of Maryland Marlene & Stewart Greenebaum Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: March 13, 2013
• First Posted: June 21, 2013
• Study Start: December 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: February 1, 2015
• Last Updated: November 7, 2019
• Results First Posted: October 7, 2015

Record last verified: 2019-11

Locations

US (1)