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Reducing Frailty for Older Cancer Survivors Using Supplements
Phase 2 trial testing Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C) in Frailty in 24 participants. Completed in 31 August 2023.
| Lead sponsor | University of Rochester |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 24 |
| Start date | 28 April 2021 |
| Primary completion | 31 August 2023 |
| Estimated completion | 31 August 2023 |
| Sites | 1 location across United States |
University of Rochester
65 and older, any sex, with Frailty or Inflammation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.
| Group | Value | 95% CI |
|---|---|---|
| Proportion of Participants Consented | 0.375 |
Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms.
| Group | Value | 95% CI |
|---|---|---|
| Proportion of Participants Randomized | 0.583 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 1 | |
| Usual Care Group | 1 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 0.857 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 2 | |
| Usual Care Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 1 | |
| Usual Care Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 1 | |
| Usual Care Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 1 | |
| Usual Care Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 1 | |
| Usual Care Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 1 | |
| Usual Care Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 2 | |
| Usual Care Group | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 2 | |
| Usual Care Group | 1 |
Time frame: 12 weeks. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Intervention Group | Usual Care Group |
|---|---|---|---|
| Fatigue - Grade 1 | General disorders | — | — |
| Insomnia - Grade 1 | Psychiatric disorders | — | — |
| Gas/Flatulence - Grade 1 | Gastrointestinal disorders | — | — |
| Constipation - Grade 1 | Gastrointestinal disorders | — | — |
| Diarrhea - Grade 1 | Gastrointestinal disorders | — | — |
| Indigestion/Dyspesia - Grade 1 | Gastrointestinal disorders | — | — |
| Nausea - Grade 1 | Gastrointestinal disorders | — | — |
| Gas/Flatulence - Grade 2 | Gastrointestinal disorders | — | — |
Data from ClinicalTrials.gov NCT04553666 adverse events section.
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
4 peer-reviewed publications reference this trial (live from Europe PMC):
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