Digestive System Diseases

Mouth and Tooth Diseases

All Conditions

Neoplasms

Ear, Nose, and Throat Diseases

Mucositis

Oropharyngeal Neoplasms

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Lidocaine

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).

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.

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 such as viscous Lidocaine for relief of pain

Usual medical care

Ting Bao, MD, DABMA

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.

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.

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

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.

All acupuncture side effects will be recorded

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

University of Maryland, Baltimore

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).

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).

Usual medical care: usual medical care such as viscous Lidocaine for relief of pain

Acupuncture With Seirin® Needles

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.

Usual medical care: usual medical care such as viscous Lidocaine for relief of pain

Usual Medical Care

Total

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

The PI left the institution before the end of the study; therefore the study was withdrawn in clinicaltrials.gov and IRB closed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer	NCT01883908	Mucositis Oropharyngeal C...	Acupuncture wit... Usual medical c...	18 Years -	University of Maryland, Baltimore
Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer	NCT01883908	Mucositis Oropharyngeal C...	Acupuncture wit... Usual medical c...	18 Years -	University of Maryland, Baltimore

Spots Global Cancer Trial Database for acupuncture with seirin® needles