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Quality-of-Life Assessment for Colorectal Cancer

Phase 2 & 3
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month post-oxaliplatin treatment
Awards & highlights

Study Summary

This trial is testing duloxetine to see if it can help prevent pain, tingling, and numbness caused by oxaliplatin in patients with colorectal cancer.

Who is the study for?
This trial is for stage II-III colorectal cancer patients who are about to receive oxaliplatin treatment and have no prior neurotoxic chemotherapy, pre-existing neuropathy, seizure disorders, glaucoma, severe psychiatric conditions or substance abuse. They must not be on certain medications like MAOIs or strong CYP1A2 inhibitors and should not be pregnant.Check my eligibility
What is being tested?
The trial is testing whether duloxetine can prevent peripheral neuropathy (pain, tingling, numbness) in patients receiving oxaliplatin for colorectal cancer. It involves comparing the effects of duloxetine with a placebo while monitoring quality-of-life through questionnaires.See study design
What are the potential side effects?
Duloxetine may cause side effects such as nausea, dry mouth, sleepiness, fatigue, constipation, loss of appetite and increased sweating. It might also affect mood and could potentially lead to more serious mental health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 month post-oxaliplatin treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month post-oxaliplatin treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Chronic neuropathic pain response (Phase III)
Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase II)
Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase III)
Secondary outcome measures
Incidence of adverse events, including duloxetine side effects of nausea, dry mouth, dizziness, somnolence, fatigue, and insomnia (Phase II)
Incidence of adverse events, including duloxetine side effects of nausea, dry mouth, dizziness, somnolence, fatigue, and insomnia (Phase III)
Serially measured patient reported on the average pain scores (Phase III)
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase III, Arm I (duloxetine hydrochloride)Experimental Treatment5 Interventions
Patients in Phase III receive most promising dose of duloxetine hydrochloride from Phase II PO QD in the absence of unacceptable toxicity.
Group II: Phase II, Arm II (duloxetine hydrochloride)Experimental Treatment5 Interventions
Patients in Phase II receive duloxetine hydrochloride 30 mg (1 duloxetine capsule) orally (PO) once daily (QD) during week 1, duloxetine hydrochloride 60 mg (2 duloxetine capsules) PO QD during weeks 2-16, followed by duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD during week 17 in the absence of unacceptable toxicity.
Group III: Phase II, Arm I (duloxetine hydrochloride, placebo)Experimental Treatment6 Interventions
Patients in Phase II receive duloxetine hydrochloride 30 mg (1 duloxetine capsule) orally (PO) once daily (QD) during week 1, duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD and placebo (1 placebo capsule) PO QD during weeks 2-16, followed by duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD during week 17 in the absence of unacceptable toxicity.
Group IV: Phase II, Arm III (placebo)Placebo Group4 Interventions
Patients in Phase II receive placebo (1 placebo capsule) orally (PO) once daily (QD) during week 1, placebo (2 placebo capsules) PO QD weeks 2-16, followed by placebo (1 placebo capsule) PO QD during week 17 in the absence of unacceptable toxicity.
Group V: Phase III, Arm II (placebo)Placebo Group4 Interventions
Patients in Phase III receive placebo PO QD in the absence of unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duloxetine Hydrochloride
2006
Completed Phase 4
~1210
Oxaliplatin
2011
Completed Phase 4
~2560
Duloxetine
2011
Completed Phase 4
~4170

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,506 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,290 Total Patients Enrolled
Ellen M. Lavoie Smith, PhDStudy ChairThe University of Alabama at Birmingham School of Nursing

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to take part in this research?

"That is correct, the online information portal clinicaltrials.gov has verified that this study is still recruiting patients. This specific research project was first made public on May 1st, 2020 and has since been updated on November 1st, 2020. There is a total goal of 327 enrollees, which will be gathered from 100 different locations."

Answered by AI

What are the most essential goals of this experiment?

"The primary outcome of this clinical trial is to prevent sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase III). This will be measured over a Up to 1 month post-oxaliplatin treatment time frame. Secondary outcomes include the incidence of adverse events, including duloxetine side effects of nausea, dry mouth, dizziness, somnolence, fatigue, and insomnia (Phase III) as well as the incidence of adverse events, including duloxetine side effects of nausea, dry mouth, dizziness, somnolence, fatigue, and insomnia ("

Answered by AI

What does Quality-of-Life Assessment usually entail?

"Prostatectomy patients typically utilize Quality-of-Life Assessment to help make treatment decisions. However, this method is also effective for those with dpn, stage iii colon cancer, and knee ailments."

Answered by AI

How many individuals are testing this medication?

"Yes, this is an ongoing trial that was initially posted on May 1st, 2020. As of the latest update on November 1st, 2022, the study is looking for 327 patients from 100 different locations."

Answered by AI

Is this the first investigation of its kind measuring Quality-of-Life?

"Currently, 380 ongoing clinical trials are investigating Quality-of-Life Assessment. Of these, 129 are in Phase 3. Although a number of these experiments are taking place in Woolloongabba, Queensland, there are actually 14649 clinical trial sites around the world testing different aspects of Quality-of-Life Assessment."

Answered by AI

How many different locations are conducting this experiment?

"Currently, this trial is taking place at 100 different sites, which include Sanford Cancer Center Worthington, Ascension Southeast Wisconsin Hospital - Franklin, Cancer and Blood Specialists-Henderson, and 97 other locations."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
City of Hope South Pasadena
Fairview Southdale Hospital
Augusta Oncology Associates PC-Wheeler
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Just looking for more help Tired, worn out, need a cure.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer
2020. "Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04137107.
All > Colorectal Cancer Glendale > Peripheral Neuropathy
~62 spots leftby Feb 2025
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