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Cancer Preventive Agent

Nutritional Supplementation for Lung Cancer

Q: Does this clinical research protocol impose an age restriction on its participants?

This medical trial has defined a range of eligibility in regards to age, with the minimum being 55 and the maximum 77.

Q: Is it possible to partake in this research project?

The trial is open to 96 people with tobacco-related carcinoma between the ages of 55 and 77. The essential requirements include a 30 pack-year <a href="https://www.withpower.com/clinical-trials/smoking">smoking</a> history, status as either an ongoing smoker or one who has quit in the last 15 years, agreement to take a standardised vitamin/mineral supplement, and abstention from other nutritional supplements for its duration.

Q: Is enrollment for this clinical experiment currently open?

According to clinicaltrials.gov, this particular medical trial is no longer recruiting patients; the listing was last updated on July 4th 2022 and first posted on October 25th 2019. Fortunately, there are 2,496 other studies presently seeking participants.

Phase < 1

Waitlist Available

Led By Daniel Spakowicz, PhD, MS

Research Sponsored by Ohio State University Comprehensive Cancer Center

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 3 years

Awards & highlights

Study Summary

This trial is testing whether black raspberry nectar can change the gut microbiome and reduce inflammation that may lead to lung cancer.

Eligible Conditions

Lung Cancer
Tobacco-Related Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Biologic responses to the black raspberry (BRB) nectar

Changes in stool microbe relative abundances

Inflammatory markers found in nasal brushings

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (placebo, BRB nectar, biospecimen collection)Experimental Treatment4 Interventions

Patients receive placebo PO BID for weeks 0-4 and then receive BRB nectar PO BID for weeks 6-10 in the absence of unacceptable toxicity. Patients also undergo collection of nasal swabs, blood, urine, and stool samples at weeks 0, 4, 6, and 10.

Group II: Arm I (BRB nectar, placebo, biospecimen collection)Experimental Treatment4 Interventions

Patients receive BRB nectar PO BID for weeks 0-4 and then receive placebo PO BID for weeks 6-10 in the absence of unacceptable toxicity. Patients also undergo collection of nasal swabs, blood, urine, and stool samples at weeks 0, 4, 6, and 10.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Nutritional Supplementation

2019

Completed Early Phase 1

~220

Placebo Administration

2018

Completed Phase 3

~2540

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

290,071 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,571 Total Patients Enrolled

Daniel Spakowicz, PhD, MSPrincipal InvestigatorOhio State University Comprehensive Cancer Center

1 Previous Clinical Trials

150 Total Patients Enrolled

Frequently Asked Questions

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

Does this clinical research protocol impose an age restriction on its participants?

"This medical trial has defined a range of eligibility in regards to age, with the minimum being 55 and the maximum 77."

Answered by AI

Is it possible to partake in this research project?

"The trial is open to 96 people with tobacco-related carcinoma between the ages of 55 and 77. The essential requirements include a 30 pack-year smoking history, status as either an ongoing smoker or one who has quit in the last 15 years, agreement to take a standardised vitamin/mineral supplement, and abstention from other nutritional supplements for its duration."

Answered by AI

Is enrollment for this clinical experiment currently open?

"According to clinicaltrials.gov, this particular medical trial is no longer recruiting patients; the listing was last updated on July 4th 2022 and first posted on October 25th 2019. Fortunately, there are 2,496 other studies presently seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study

Daniel Spakowicz 2019. "Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04267874.