Frailty, Inflammation
Conditions
Brief summary
The purpose of the study is to examine the feasibility and safety of twelve weeks oral supplementation of Epigallocatechin-3-gallate (EGCG) in older survivors of cancer
Interventions
DRUGEpigallocatechin-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
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients in the intervention Arm will receive 800 mg Epigallocatechin gallate (EGCG) + 250mg Ascorbic Acid
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be age 65 or over. 2. Be diagnosed with stage I-III Cancer. 3. Have completed curative intent treatment ≤10 years prior to screening. (Patients on endocrine therapies are allowed to enroll.) 4. Have a Fried's Frailty Score (FFS) of ≥ 2. 5. Able to provide informed consent, or have consent given by patient-designated health care proxy per institutional policies and University of Rochester Cancer Control guidelines.
Exclusion criteria
Study subjects must not: 1. Have chemotherapy planned for the during of the study. 2. Have abnormal liver function tests (ALT, AST and bilirubin ≥3 times institutional upper limit of normal) per most recent available lab test (within 3 months of screening). 3. Have uncontrolled or unmanaged liver disease. 4. Consume more than 6 cups of green tea per day. 5. Have known allergies to caffeine. 6. Be diagnosed with a major psychiatric illness requiring hospitalization within the last year. 7. Be diagnosed with dementia. 8. Cannot provide informed consent due to lack of decision making capacity (as determined by the patient's oncologist) and has no patient-designated health care proxy per institutional policies and University of Rochester Cancer Control URCC guidelines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility: Rates of Consent | Baseline | Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study. |
| Recruitment Feasibility: Rates of Randomization | Baseline | Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms. |
| The Proportion of Participants That Completed the Study | 12 week | To 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. |
| The Proportion of Participants That Were Adherent to the Intervention | 12 week | To 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). |
| Safety of the EGCG Intervention | 12 weeks | Total (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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| Usual Care Group No study pills. Followed Usual Care procedures for an older survivor of cancer according to oncology care teams' directions. | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | Usual Care Group | Intervention Group | Total |
|---|---|---|---|
| Age, Customized Age, Years: Mean | 72.6 years | 76.6 years | 74.5 years |
| Cancer Stage Stage I | 3 Participants | 4 Participants | 7 Participants |
| Cancer Stage Stage II | 3 Participants | 2 Participants | 5 Participants |
| Cancer Stage Stage III | 1 Participants | 1 Participants | 2 Participants |
| Cancer Treatment Surgery Alone | 3 Participants | 2 Participants | 5 Participants |
| Cancer Treatment Surgery with Chemotherapy | 3 Participants | 2 Participants | 5 Participants |
| Cancer Treatment Surgery with Radiation | 1 Participants | 3 Participants | 4 Participants |
| Cancer Type Breast | 3 Participants | 3 Participants | 6 Participants |
| Cancer Type Colon/Rectal/Anal | 3 Participants | 4 Participants | 7 Participants |
| Cancer Type Prostate | 1 Participants | 0 Participants | 1 Participants |
| Education College and Above | 5 Participants | 6 Participants | 11 Participants |
| Education Some College | 2 Participants | 1 Participants | 3 Participants |
| Employment Status Employed | 1 Participants | 1 Participants | 2 Participants |
| Employment Status Retired | 6 Participants | 6 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 6 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Married | 5 Participants | 4 Participants | 9 Participants |
| Marital Status Unmarried | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 6 / 7 | 3 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
Recruitment Feasibility: Rates of Consent
Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Proportion of Participants Consented | Recruitment Feasibility: Rates of Consent | 0.375 proportion of participants |
Primary
Recruitment Feasibility: Rates of Randomization
Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Proportion of Participants Consented | Recruitment Feasibility: Rates of Randomization | 0.583 proportion of participants |
Primary
Safety of the EGCG Intervention
Total (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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Proportion of Participants Consented | Safety of the EGCG Intervention | Constipation-Grade 1 | 1 Participants |
| Proportion of Participants Consented | Safety of the EGCG Intervention | Gas/Flatulence-Grade 1 | 2 Participants |
| Proportion of Participants Consented | Safety of the EGCG Intervention | Gas/Flatulence-Grade 2 | 1 Participants |
| Proportion of Participants Consented | Safety of the EGCG Intervention | Diarrhea-Grade 1 | 1 Participants |
| Proportion of Participants Consented | Safety of the EGCG Intervention | Indigestion/Dyspepsia-Grade 1 | 1 Participants |
| Proportion of Participants Consented | Safety of the EGCG Intervention | Nausea-Grade 1 | 1 Participants |
| Proportion of Participants Consented | Safety of the EGCG Intervention | Fatigue-Grade 1 | 2 Participants |
| Proportion of Participants Consented | Safety of the EGCG Intervention | Insomnia-Grade 1 | 2 Participants |
| Usual Care Group | Safety of the EGCG Intervention | Insomnia-Grade 1 | 1 Participants |
| Usual Care Group | Safety of the EGCG Intervention | Indigestion/Dyspepsia-Grade 1 | 0 Participants |
| Usual Care Group | Safety of the EGCG Intervention | Gas/Flatulence-Grade 1 | 0 Participants |
| Usual Care Group | Safety of the EGCG Intervention | Fatigue-Grade 1 | 2 Participants |
| Usual Care Group | Safety of the EGCG Intervention | Gas/Flatulence-Grade 2 | 0 Participants |
| Usual Care Group | Safety of the EGCG Intervention | Constipation-Grade 1 | 0 Participants |
| Usual Care Group | Safety of the EGCG Intervention | Nausea-Grade 1 | 0 Participants |
| Usual Care Group | Safety of the EGCG Intervention | Diarrhea-Grade 1 | 0 Participants |
Primary
The Proportion of Participants That Completed the Study
To 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.
Time frame: 12 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Proportion of Participants Consented | The Proportion of Participants That Completed the Study | 1 proportion of participants |
| Usual Care Group | The Proportion of Participants That Completed the Study | 1 proportion of participants |
Primary
The Proportion of Participants That Were Adherent to the Intervention
To 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).
Time frame: 12 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Proportion of Participants Consented | The Proportion of Participants That Were Adherent to the Intervention | 0.857 proportion of participants |