Trial Outcomes & Findings for Reducing Frailty for Older Cancer Survivors Using Supplements (NCT NCT04553666)
NCT ID: NCT04553666
Last Updated: 2024-09-19
Results Overview
Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.
COMPLETED
PHASE2
24 participants
Baseline
2024-09-19
Participant Flow
Patients were recruited from clinical sites within Wilmot Cancer Institute between April 2021 and March 2023. Eligible patients were aged 65 or older, diagnosed with Stage I-III solid cancer, completed curative intent treatment 10 years or less before being screened, and had a Fried's Frailty Score (FFS ≥ 2); assessed by measuring grip strength, weight loss, physical activity, fatigue, and a 4-meter walk test. The first participant was consented on April 28, 2021, and randomized on May 6, 2021.
Sixty four (64) potentially eligible participants were approached and 24 participants were consented. Of the 24 consented subjects: 5 screen failed (participant was consented but didn't fully meet eligibility criteria e.g. meet frailty cut off or liver toxicity screen); 4 screen withdrew (participant was consented but withdrew from the study before the baseline visit for randomization), and 1 was lost to follow up. Fourteen (14) participants were randomized to the treatment groups.
Participant milestones
| Measure |
Intervention Group
Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day
Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C): 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks
|
Usual Care Group
No study pills. Followed Usual Care procedures for a survivor of cancer according to oncology care teams' directions.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Frailty for Older Cancer Survivors Using Supplements
Baseline characteristics by cohort
| Measure |
Intervention Group
n=7 Participants
Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day
Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C): 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks
|
Usual Care Group
n=7 Participants
No study pills. Followed Usual Care procedures for an older survivor of cancer according to oncology care teams' directions.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, Years: Mean
|
76.6 years
n=5 Participants
|
72.6 years
n=7 Participants
|
74.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education
Some College
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
College and Above
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Marital Status
Married
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Marital Status
Unmarried
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Employment Status
Retired
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Employment Status
Employed
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cancer Stage
Stage I
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Cancer Stage
Stage II
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Cancer Stage
Stage III
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cancer Type
Colon/Rectal/Anal
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Cancer Type
Breast
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Cancer Type
Prostate
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cancer Treatment
Surgery Alone
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Cancer Treatment
Surgery with Chemotherapy
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Cancer Treatment
Surgery with Radiation
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Since this outcome measure looks at the number of participants approached versus consented, the number of participants analyzed was the 64 approached instead of the 14 that were randomized.
Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.
Outcome measures
| Measure |
Proportion of Participants Consented
n=64 Participants
Proportion of participants approached compared to those consented onto the study
|
Usual Care Group
No study pills. Followed Usual Care procedures for an older survivor of cancer according to oncology care teams' directions.
|
|---|---|---|
|
Recruitment Feasibility: Rates of Consent
|
0.375 proportion of participants
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Since this outcome measure looks at the number of participants consented versus randomized, the number of participants analyzed was the 24 consented instead of the 14 that were randomized.
Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms.
Outcome measures
| Measure |
Proportion of Participants Consented
n=24 Participants
Proportion of participants approached compared to those consented onto the study
|
Usual Care Group
No study pills. Followed Usual Care procedures for an older survivor of cancer according to oncology care teams' directions.
|
|---|---|---|
|
Recruitment Feasibility: Rates of Randomization
|
0.583 proportion of participants
|
—
|
PRIMARY outcome
Timeframe: 12 weekTo determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining how many participants completed the study.The number of participants randomized compared to the number of participants that returned for the post intervention visit.
Outcome measures
| Measure |
Proportion of Participants Consented
n=7 Participants
Proportion of participants approached compared to those consented onto the study
|
Usual Care Group
n=7 Participants
No study pills. Followed Usual Care procedures for an older survivor of cancer according to oncology care teams' directions.
|
|---|---|---|
|
The Proportion of Participants That Completed the Study
|
1 proportion of participants
|
1 proportion of participants
|
PRIMARY outcome
Timeframe: 12 weekTo determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining the proportion of participants that were adherent to the intervention (taking \>70% of study drug).
Outcome measures
| Measure |
Proportion of Participants Consented
n=7 Participants
Proportion of participants approached compared to those consented onto the study
|
Usual Care Group
No study pills. Followed Usual Care procedures for an older survivor of cancer according to oncology care teams' directions.
|
|---|---|---|
|
The Proportion of Participants That Were Adherent to the Intervention
|
0.857 proportion of participants
|
—
|
PRIMARY outcome
Timeframe: 12 weeksTotal (sum) and severity of adverse events (AEs) reported over 12 weeks of being on study graded using CTCAE v5.0 was determined. Participants were called weekly by study coordinator and asked to report concerns including: symptoms, signs, illnesses, or experiences that develop or worsen during the study. These concerns were graded according to the CTCAE v5.0. Number of participants who reported any AEs during the 12 weeks of the study are reported.
Outcome measures
| Measure |
Proportion of Participants Consented
n=7 Participants
Proportion of participants approached compared to those consented onto the study
|
Usual Care Group
n=7 Participants
No study pills. Followed Usual Care procedures for an older survivor of cancer according to oncology care teams' directions.
|
|---|---|---|
|
Safety of the EGCG Intervention
Insomnia-Grade 1
|
2 Participants
|
1 Participants
|
|
Safety of the EGCG Intervention
Gas/Flatulence-Grade 1
|
2 Participants
|
0 Participants
|
|
Safety of the EGCG Intervention
Gas/Flatulence-Grade 2
|
1 Participants
|
0 Participants
|
|
Safety of the EGCG Intervention
Constipation-Grade 1
|
1 Participants
|
0 Participants
|
|
Safety of the EGCG Intervention
Diarrhea-Grade 1
|
1 Participants
|
0 Participants
|
|
Safety of the EGCG Intervention
Indigestion/Dyspepsia-Grade 1
|
1 Participants
|
0 Participants
|
|
Safety of the EGCG Intervention
Nausea-Grade 1
|
1 Participants
|
0 Participants
|
|
Safety of the EGCG Intervention
Fatigue-Grade 1
|
2 Participants
|
2 Participants
|
Adverse Events
Intervention Group
Usual Care Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=7 participants at risk
Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day
Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C): 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks
|
Usual Care Group
n=7 participants at risk
No study pills. Followed Usual Care procedures for an older survivor of cancer according to oncology care teams' directions.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation - Grade 1
|
14.3%
1/7 • Number of events 1 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea - Grade 1
|
14.3%
1/7 • Number of events 1 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Gastrointestinal disorders
Indigestion/Dyspesia - Grade 1
|
14.3%
1/7 • Number of events 1 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Gastrointestinal disorders
Nausea - Grade 1
|
14.3%
1/7 • Number of events 1 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
General disorders
Fatigue - Grade 1
|
28.6%
2/7 • Number of events 3 • 12 weeks
|
28.6%
2/7 • Number of events 3 • 12 weeks
|
|
Psychiatric disorders
Insomnia - Grade 1
|
28.6%
2/7 • Number of events 4 • 12 weeks
|
14.3%
1/7 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Gas/Flatulence - Grade 1
|
28.6%
2/7 • Number of events 4 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Gastrointestinal disorders
Gas/Flatulence - Grade 2
|
14.3%
1/7 • Number of events 1 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
Additional Information
Dr. Nikesha Gilmore, Assistant Professor
University of Rochester Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place