Trial Outcomes & Findings for Metformin Hydrochloride in Affecting Cytokines and Exosomes in Patients With Head and Neck Cancer (NCT NCT03109873)
NCT ID: NCT03109873
Last Updated: 2025-04-30
Results Overview
Mixed effects linear regression will be used to model longitudinal measurements of each cytokine.
COMPLETED
EARLY_PHASE1
9 participants
Up to 1 year
2025-04-30
Participant Flow
Participant milestones
| Measure |
Arm I (EBRT, Metformin Hydrochloride)
Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive metformin hydrochloride PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.
External Beam Radiation Therapy: Undergo External Beam Radiation Therapy
Metformin Hydrochloride: Given orally
|
Arm II (EBRT, Placebo)
Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive placebo PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.
External Beam Radiation Therapy: Undergo External Beam Radiation Therapy
Placebo: Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metformin Hydrochloride in Affecting Cytokines and Exosomes in Patients With Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Arm I (EBRT, Metformin Hydrochloride)
n=5 Participants
Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive metformin hydrochloride PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.
External Beam Radiation Therapy: Undergo External Beam Radiation Therapy
Metformin Hydrochloride: Given orally
|
Arm II (EBRT, Placebo)
n=4 Participants
Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive placebo PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.
External Beam Radiation Therapy: Undergo External Beam Radiation Therapy
Placebo: Given orally
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Due to insufficient accrual, statistical results cannot be reported.
Mixed effects linear regression will be used to model longitudinal measurements of each cytokine.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Due to insufficient accrual, statistical results cannot be reported.
Analysis will be primarily descriptive. The distribution of swallowing function and mucositis scores will be summarized by arm using means, medians, standard deviations, and ranges.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Due to insufficient accrual, statistical results cannot be reported.
The objective response rate will be estimated by arm along with an exact 95% binomial confidence interval
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Due to insufficient accrual, statistical results cannot be reported.
Longitudinal measurements of exosomes will also be modeled using mixed effects linear regression. This analysis is treated as separate from the cytokine questions and the p-value will not be adjusted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Due to insufficient accrual, statistical results cannot be reported.
Evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Outcome measures
Outcome data not reported
Adverse Events
Arm I (EBRT, Metformin Hydrochloride)
Arm II (EBRT, Placebo)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (EBRT, Metformin Hydrochloride)
n=5 participants at risk
Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive metformin hydrochloride PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.
External Beam Radiation Therapy: Undergo External Beam Radiation Therapy
Metformin Hydrochloride: Given orally
|
Arm II (EBRT, Placebo)
n=4 participants at risk
Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive placebo PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.
External Beam Radiation Therapy: Undergo External Beam Radiation Therapy
Placebo: Given orally
|
|---|---|---|
|
General disorders
Xerostomia
|
80.0%
4/5 • baseline through one year after completion of treatment
|
50.0%
2/4 • baseline through one year after completion of treatment
|
|
General disorders
Dysphagia
|
80.0%
4/5 • baseline through one year after completion of treatment
|
50.0%
2/4 • baseline through one year after completion of treatment
|
|
General disorders
Fatigue
|
80.0%
4/5 • baseline through one year after completion of treatment
|
75.0%
3/4 • baseline through one year after completion of treatment
|
|
General disorders
Dysgeusia
|
80.0%
4/5 • baseline through one year after completion of treatment
|
75.0%
3/4 • baseline through one year after completion of treatment
|
Additional Information
Dr. Adam Luginbuhl
Sidney Kimmel Cancer Center at Thomas Jefferson University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place