Mucositis, Oropharyngeal Cancer
Conditions
Keywords
Acupuncture therapy, Mucositis, oropharyngeal cancer
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.
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.
Interventions
DEVICEAcupuncture 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).
OTHERUsual medical care
usual medical care such as viscous Lidocaine for relief of pain
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Side Effects of Acupuncture Treatment | 16 weeks | All acupuncture side effects will be recorded |
| Number of Patients Completing Acupuncture Treatment | 16 weeks | Feasibility is defined as greater than 80% patients in the trial completing at least 4 acupuncture sessions. |
Countries
United States
Participant flow
Recruitment details
University Medical Centers and Hospital Based Oncology Programs recruited participants from January 2013 until June 2014.
Pre-assignment details
Four participants were enrolled, with three randomized to receive acupuncture and one randomized to receive standard medical care.
Participants by arm
| Arm | Count |
|---|---|
| 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).
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 | 3 |
| 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.
Usual medical care: usual medical care such as viscous Lidocaine for relief of pain | 1 |
| Total | 4 |
Baseline characteristics
| Characteristic | Acupuncture With Seirin® Needles | Usual Medical Care | Total |
|---|---|---|---|
| Age, Customized | 63 years | 55 years | 63 years |
| Region of Enrollment United States | 3 participants | 1 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 |
Outcome results
Primary
Number of Patients Completing Acupuncture Treatment
Feasibility is defined as greater than 80% patients in the trial completing at least 4 acupuncture sessions.
Time frame: 16 weeks
Population: Zero participants analyzed due to early termination of study.
Primary
Side Effects of Acupuncture Treatment
All acupuncture side effects will be recorded
Time frame: 16 weeks
Population: Zero participants analyzed due to early termination of study.