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Cannabinoid

Hemp-based CBD for Peripheral Neuropathy (Coala-T-CBD Trial)

Phase 2

Waitlist Available

Led By Marisa Weiss, MD

Research Sponsored by Main Line Health

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 every two weeks for twelve weeks during intervention; one month follow-up

Awards & highlights

Coala-T-CBD Trial Summary

This trial is studying a hemp-based cannabidiol product to see if it can help relieve chemotherapy-induced neuropathy in cancer patients.

Eligible Conditions

Chemotherapy-induced Peripheral Neuropathy
Uterine Cancer
Pancreatic Cancer
Colorectal Cancer
Breast Cancer
Ovarian Cancer

Coala-T-CBD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every two weeks for twelve weeks during intervention; one month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every two weeks for twelve weeks during intervention; one month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and every two weeks for twelve weeks during intervention; one month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in CIPN symptom severity

Change in pain sensation during intervention and at follow-up

Change in pain severity

+4 more

Secondary outcome measures

Adherence to CBD Products

Rate of side effects using medical-grade CBD concentrates

Receptivity and accrual rate to clinical studies involving cannabis-based substances.

Coala-T-CBD Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Hemp-based CBDExperimental Treatment1 Intervention

Group II: Placebo Oral TabletPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Main Line HealthLead Sponsor

20 Previous Clinical Trials

6,723 Total Patients Enrolled

Ananda Hemp, Inc.UNKNOWN

1 Previous Clinical Trials

40 Total Patients Enrolled

Marisa Weiss, MDPrincipal Investigator - Main Line Health System

Lankenau Medical Center, Main Line Health Imaging LP, Paoli Hospital

University Of Pennsylvania School Of Medicine (Medical School)

University Of Pa Hlth System (Residency)

Frequently Asked Questions

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

Has recruitment for this trial begun, and is it still open to new participants?

"Unfortunately, this trial has concluded its patient recruitment period. It was first listed on May 27th 2020 and last updated August 29th 2022. However, there are currently 3306 studies involving breast cancer that need participants as well as 79 trials searching for Hemp-based CBD recruits."

Answered by AI

What is the cap for the number of volunteers involved in this research?

"As of August 29th 2022, this trial has finished recruiting patients. It was initially published on May 27th 2020. If you're searching for other trials, there are 3306 studies looking to enroll individuals living with breast cancer and 79 clinical investigations regarding Hemp-based CBD currently accepting participants."

Answered by AI

Has there been any additional research into the efficacy of Hemp-based CBD?

"Currently, nearly 80 clinical trials are examining the effects of Hemp-based CBD with 16 in Phase 3. While most studies take place at Ribeirao Preto, Sao Paulo there is still a wide network of 290 sites conducting research on this topic."

Answered by AI

Is consuming Hemp-based CBD a risk to one's health?

"The safety rating of CBD derived from hemp is provisionally rated 2 given that there are no efficacy reports although some data suggests it may be safe."

Answered by AI

Recent research and studies

The OncologistJournal

Oral Glutamine Is Effective for Preventing Oxaliplatin-induced Neuropathy in Colorectal Cancer Patients

Wang, Wei-Shu, Jen-Kou Lin, Tzu-Chen Lin, Wei-Shone Chen, Jeng-Kae Jiang, Huann-Sheng Wang, Tzeon-Jye Chiou, Jin-Hwang Liu, Chueh-Chuan Yen, and Po-Min Chen. 2007. “Oral Glutamine Is Effective for Preventing Oxaliplatin-induced Neuropathy in Colorectal Cancer Patients”. The Oncologist. Oxford University Press (OUP). doi:10.1634/theoncologist.12-3-312.

Współczesna OnkologiaJournal

Chemotherapy-induced Polyneuropathy. Part I. Pathophysiology [polish Version: Polineuropatia Wywołana Chemioterapią. Część I. Patofizjologia P. 79]

Brzeziński, Krzysztof. 2012. “Chemotherapy-induced Polyneuropathy. Part I. Pathophysiology [polish Version: Polineuropatia Wywołana Chemioterapią. Część I. Patofizjologia P. 79]”. Współczesna Onkologia. Termedia Sp. z.o.o.. doi:10.5114/wo.2012.27341.

Seminars in OncologyJournal

Clinical Aspects and Molecular Basis of Oxaliplatin Neurotoxicity: Current Management and Development of Preventive Measures

Gamelin, Erick, Laurence Gamelin, Laura Bossi, and Stefan Quasthoff. 2002. “Clinical Aspects and Molecular Basis of Oxaliplatin Neurotoxicity: Current Management and Development of Preventive Measures”. Seminars in Oncology. Elsevier BV. doi:10.1053/sonc.2002.35525.

Current Pain and Headache ReportsJournal