An Open-Label Intervention Trial to Reduce Senescence and Improve Frailty in Adult Survivors of C… (NCT04733534) | Clinical Trial Compass
Active — Not RecruitingPhase 2
An Open-Label Intervention Trial to Reduce Senescence and Improve Frailty in Adult Survivors of Childhood Cancer
United States110 participantsStarted 2022-06-06
Plain-language summary
This is a first-in survivor pilot study with the goal of establishing preliminary evidence of efficacy, safety, and tolerability of two senolytic regimens to reduce markers of cellular senescence (primary outcome: p16\^INK4a) and improve frailty (primary outcome: walking speed) in adult survivors of childhood cancer. If successful, this pilot would provide the preliminary evidence needed for a phase 2, randomized, placebo-controlled trial to establish efficacy.
Primary Objective
* The primary aim of this proposal is to test the efficacy of two, short duration senolytic regimens: 1) combination of Dasatinib plus Quercetin and 2) Fisetin alone, to improve walking speed and decrease senescent cell abundance in blood (p16\^INKA):
* Primary endpoints of this trial will be change in walking speed and senescent cell abundance in blood (p16\^INK4A) determined at baseline and again at 60 days, within an individual arm. Extended follow up at 150 days will assess the permanence of change after completion of the trial. Secondary endpoints of this trial will be effect of intervention on additional measures of frailty (beyond walking speed; Fried criteria) and on other cell senescence markers, markers of inflammation, insulin resistance, bone resorption, and cognitive function.
Secondary Objectives
The secondary aim is to test the safety and tolerability of two different senolytic therapies.
Exploratory Objectives
* To compare the efficacy of the two senolytic regimens in improving walking speed and decreasing senescent cell abundance
* To evaluate the longitudinal pattern in measures of frailty.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant in SJLIFE and \> 5 years from diagnosis.
* ≥18 years of age.
* Frail (2 of 4 objectively measured Fried criteria adapted,(excluding self-reported fatigue as a criteria), including abnormal walking speed; muscle strength; activity level; and muscle mass). See Section 5 for details.
* CD3+ T lymphocytes: p16INK4A detected at \<34 cycles by RT PCR.
* Agrees to use contraception as Dasatinib is teratogenic.
* Female participant has a negative pregnancy test.
* QTc \<450 milliseconds in electrocardiogram.
* Able to take oral medications.
Exclusion Criteria:
* Currently has HIV, Hepatitis B/C, invasive fungal infection
* Anemia or as per clinical judgement.
* Hypersensitivity to study drugs
* New/active malignancy/taking chemotherapy and/or radiation except non-melanoma skin cancers
* Currently taking medications that inhibit or induce CYP3A4 or that are sensitive to substrates or substrates with a narrow therapeutic range for CYP2C8, CYP2C9, or CYP2D6.
* Taking anticoagulants or antimicrobial agents
* Currently taking Quercetin or Fisetin
* Pregnant or nursing at time of enrollment/during the study
* Impaired cognition or motor performance due to congenital defects
* Currently participating in another research intervention to aid walking speed or other measures of frailty including muscle strength; low activity; muscle mass or exhaustion/fatigue
* Participant is a Non-English Speaker
* Uncontrolled pleural/pericardial effusion or ascites
* Subj…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.