Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2012 |
| End Date: | February 2015 |
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.
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.
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.
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.
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