Ignite Creation Date:
2024-05-06 @ 1:45 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01883908
Status:
TERMINATED
Last Update Posted:
2019-11-07
First Post:
2013-03-13
Brief Title:
Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The project is terminated due to that fact that the PI has moved to another institution and there are no resources to keep the study open in either institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GCC1229
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
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 n20 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 v30 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GCC1229 | OTHER | University of Maryland Greenebaum Cancer Center | None |