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Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer (GCC1229)

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ClinicalTrials.gov Identifier: NCT01883908
Recruitment Status : Terminated (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.)
First Posted : June 21, 2013
Results First Posted : October 7, 2015
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Ting Bao, University of Maryland, College Park

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Mucositis
Oropharyngeal Cancer
Interventions Device: Acupuncture with Seirin® needles
Other: Usual medical care
Enrollment 4
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.
Arm/Group Title Acupuncture With Seirin® Needles Usual Medical Care
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 3 1
Completed 3 1
Not Completed 0 0
Arm/Group Title Acupuncture With Seirin® Needles Usual Medical Care Total
Hide Arm/Group Description

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

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

Total of all reporting groups
Overall Number of Baseline Participants 3 1 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 1 participants 4 participants
63
(53 to 73)
55
(55 to 55)
63
(53 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 4 participants
Female
1
  33.3%
0
   0.0%
1
  25.0%
Male
2
  66.7%
1
 100.0%
3
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 1 participants 4 participants
3 1 4
1.Primary Outcome
Title Side Effects of Acupuncture Treatment
Hide Description All acupuncture side effects will be recorded
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed due to early termination of study.
Arm/Group Title Acupuncture With Seirin® Needles Usual Medical Care
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Number of Patients Completing Acupuncture Treatment
Hide Description Feasibility is defined as greater than 80% patients in the trial completing at least 4 acupuncture sessions.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed due to early termination of study.
Arm/Group Title Acupuncture With Seirin® Needles Usual Medical Care
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acupuncture With Seirin® Needles Usual Medical Care
Hide Arm/Group Description

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

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

All-Cause Mortality
Acupuncture With Seirin® Needles Usual Medical Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Acupuncture With Seirin® Needles Usual Medical Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acupuncture With Seirin® Needles Usual Medical Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/1 (0.00%) 
The PI left the institution before the end of the study; therefore the study was withdrawn in clinicaltrials.gov and IRB closed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michelle Medeiros
Organization: University of Maryland Baltimore Greenebaum Cancer Center
Phone: 410-328-1160
EMail: mmedeiros@umm.edu
Layout table for additonal information
Responsible Party: Ting Bao, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT01883908     History of Changes
Other Study ID Numbers: HP-00053319
GCC1229 ( Other Identifier: University of Maryland Greenebaum Cancer Center )
First Submitted: March 13, 2013
First Posted: June 21, 2013
Results First Submitted: April 21, 2015
Results First Posted: October 7, 2015
Last Update Posted: October 7, 2015