Trial Outcomes & Findings for Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer (NCT NCT01883908)
NCT ID: NCT01883908
Last Updated: 2019-11-07
Results Overview
All acupuncture side effects will be recorded
TERMINATED
NA
4 participants
16 weeks
2019-11-07
Participant Flow
University Medical Centers and Hospital Based Oncology Programs recruited participants from January 2013 until June 2014.
Four participants were enrolled, with three randomized to receive acupuncture and one randomized to receive standard medical care.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer
Baseline characteristics by cohort
| Measure |
Acupuncture With Seirin® Needles
n=3 Participants
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
|
Usual Medical Care
n=1 Participants
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
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
63 years
n=5 Participants
|
55 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Zero participants analyzed due to early termination of study.
All acupuncture side effects will be recorded
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 16 weeksPopulation: Zero participants analyzed due to early termination of study.
Feasibility is defined as greater than 80% patients in the trial completing at least 4 acupuncture sessions.
Outcome measures
Outcome data not reported
Adverse Events
Acupuncture With Seirin® Needles
Usual Medical Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michelle Medeiros
University of Maryland Baltimore Greenebaum Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place