Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601218
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Impact of Daily Oral Cannabis Doses in Patients with Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Study of the Effects of Cannabis on Cancer Burden Placebo-Controlled Double-Blind Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will enroll patients with cancer and participants will be randomized to receive one dose of cannabis for approximately 4 months There is a 34 or 75 chance that a participant will receive an active cannabis dose in the study There is a 14 or 25 chance that a participant will receive a placebo dose meaning a blank doseno cannabisno active drug The goals of this study are to determine 1 the safety and tolerability of cannabis in individuals with cancer and 2 if cannabis can help with the side effects of cancer and cancer treatment - including nausea and vomiting appetite pain sleep and quality of life
Detailed Description:
Primary Objective To evaluate the safety and tolerability of daily oral cannabis administration 5 mg THC 15 mg THC 15 mg THC15 mg CBD relative to placebo in patients with cancer who are on an active anti-cancer therapy The percent of patients who elect to withdrawal from the study or removed by physicianinvestigators due AEs or safety concerns in each group will be measured and compared to the placebo group
Secondary Objectives
1 To evaluate frequency and severity of safety criteria violations from dosing to 4 hrs post-dose HR O2 saturation from fitness tracker
2 To evaluate the percent of patients who withdrawal from the study or removed by physicianinvestigators for all reasons
3 To determine final tolerated dose for future study investigator determination after review of AEs participant rated VAS vitals
4 To evaluate the effects of cannabis on cancer burden total score as measured by the NCCNFunctional Assessment of Cancer Therapy FACT Symptom Index a validated questionnaire that assesses cancer burden in the form of symptoms and concerns Specifically 17 items form 4 subscales that assess Disease-Related Symptoms-Physical DRS-P Disease- Related Symptoms-Emotional DRS-E Treatment Side Effects TSE and FunctionWell-Being FWB A total score is generated and will be assessed at baseline during experimental dosing and follow-up
Participants Participants will be adult cancer patients ages 18 and older who have a histologically or cytologically confirmed locally advanced or metastatic solid tumor These patients will be actively undergoing anti-cancer therapy having been on a current regimen for at least one month prior to enrollment An ECOG performance status of 2 and adequate organ and marrow function at baseline is required A total of 80 patients will be enrolled in this study n20arm
Investigators will recruit participants from the University of Kentucky Markey Cancer Center Patients who appear to meet basicinitial study criteria will be approached by Dr and Doctors team Investigators will provide the patient with a study information card that contains basic information about the study and the contact information eg phone text email social media contacts for the UK Center on Drug and Alcohol Research CDAR Dr Babalonis and her team When contacting the CDAR the participant will have a chance to speak to staff and ask questions and will also have the opportunity to schedule an in-person screening appointment the first of two in-person screening appointments
Study Design This study will utilize a randomized double-blind placebo-controlled 4 arm design n80 n20arm The study duration will be approximately 55 months including 2 weeks of baseline no drug administered 4 months of daily dosing including approx 2 weeks of dose titration at the beginning of dosing 3 months at target dose approx 2 weeks dose taper at the end of dosing and a 1-month follow-up period no drug administered
All study participants will be randomized 1111 by the study statistician Dr Donglin Yan All patients are allowed to continue with anti-cancer therapies but not cannabinoid-based medications while enrolled in this study Patients taking checkpoint inhibitors or with HPV-positive cancers will not be enrolled due to evidence albeit limited that concomitant cannabis reduces the efficacy of checkpoint inhibitors
After enrollment and a minimum of a 2-week period of baseline data collection a participant will begin receiving experimental cannabismatched placebo doses Investigators plan to administer one blinded dose per day during the approx 4-month dosing protocol including titration and taper One oral ie edible daily dose will be administered on an outpatient basis Due to DEA regulations eg cannabis is a Schedule I drug with many regulatory restrictions a trained research staff will visit the participant home approx once per week to deliver approx 1-2 week supply of doses Each dose will be locked in its own safe and each safe will have a unique combination code with an AirTag embedded in the safe for dose tracking capabilities if needed
Participants will FaceTime or video chat with a research team member at a pre-specified time every day During this video call the participant will be provided a code to unlock one safe The research staff member will ask the participant to open the safe and show the dose and its label on camera The research staff will verify the correct participant name date and dose code
During this call the research staff will also remind the participant to wear the fitness tracker per protocol so that the study team can monitor vitals HR O2 prior to and for 4 hrs post-dose Participants will also be provided instructions to call the on-call physicianRN if not feeling well or if an alarm on the fitness tracker is received The participant will be required to consume the dose on camera This rationale for verification of dosing is three-fold 1 to ensure no diversion occurs ie the dose is consumed by the patient and not diverted to another person 2 to verify study dosing adherence and 3 to ensure that the correct dose was administered particularly early and late in the study when doses will be titrated and tapered Participants are compensated for compliance with these calls
If a participant has known travel investigators will discuss the travel plans to determine if it is safe and advisable to take doses with them in most scenarios travel with doses will not be likely but this will be discussed at the time of consent and when travel arises In these scenarios or at other times the participant is unavailable eg hospitalized the investigatorsstudy physician will discuss a plan eg not delivering scheduled doses picking up unused doses re-starting a titration schedule if a long break is anticipated discharging from the study as a last resort
Daily assessments for this study include video calls and app-based questionnaires Participants will complete brief daily questionnaires via a smartphone app covering morning assessments of sleep quality hot flashes night sweats appetite nausea pain and overall mood as well as post-dose assessments of drug effects mood and vitals
The in-home visits by a research assistant or nurse will include dose drop-off review of adverse events and addressing any study-related concerns Monthly in-laboratory visits will assess adverse events study progress and continued enrollment with blood draws and other evaluations as scheduled Follow-up assessments will involve weekly app-based questionnaires and a final in-person visit to discuss the study experience collect weight and perform a urine drug screen
Secondary Objectives
1 To evaluate frequency and severity of safety criteria violations from dosing to 4 hrs post-dose HR O2 saturation from fitness tracker
2 To evaluate the percent of patients who withdrawal from the study or removed by physicianinvestigators for all reasons
3 To determine final tolerated dose for future study investigator determination after review of AEs participant rated VAS vitals
4 To evaluate the effects of cannabis on cancer burden total score as measured by the NCCNFunctional Assessment of Cancer Therapy FACT Symptom Index a validated questionnaire that assesses cancer burden in the form of symptoms and concerns Specifically 17 items form 4 subscales that assess Disease-Related Symptoms-Physical DRS-P Disease- Related Symptoms-Emotional DRS-E Treatment Side Effects TSE and FunctionWell-Being FWB A total score is generated and will be assessed at baseline during experimental dosing and follow-up
Participants Participants will be adult cancer patients ages 18 and older who have a histologically or cytologically confirmed locally advanced or metastatic solid tumor These patients will be actively undergoing anti-cancer therapy having been on a current regimen for at least one month prior to enrollment An ECOG performance status of 2 and adequate organ and marrow function at baseline is required A total of 80 patients will be enrolled in this study n20arm
Investigators will recruit participants from the University of Kentucky Markey Cancer Center Patients who appear to meet basicinitial study criteria will be approached by Dr and Doctors team Investigators will provide the patient with a study information card that contains basic information about the study and the contact information eg phone text email social media contacts for the UK Center on Drug and Alcohol Research CDAR Dr Babalonis and her team When contacting the CDAR the participant will have a chance to speak to staff and ask questions and will also have the opportunity to schedule an in-person screening appointment the first of two in-person screening appointments
Study Design This study will utilize a randomized double-blind placebo-controlled 4 arm design n80 n20arm The study duration will be approximately 55 months including 2 weeks of baseline no drug administered 4 months of daily dosing including approx 2 weeks of dose titration at the beginning of dosing 3 months at target dose approx 2 weeks dose taper at the end of dosing and a 1-month follow-up period no drug administered
All study participants will be randomized 1111 by the study statistician Dr Donglin Yan All patients are allowed to continue with anti-cancer therapies but not cannabinoid-based medications while enrolled in this study Patients taking checkpoint inhibitors or with HPV-positive cancers will not be enrolled due to evidence albeit limited that concomitant cannabis reduces the efficacy of checkpoint inhibitors
After enrollment and a minimum of a 2-week period of baseline data collection a participant will begin receiving experimental cannabismatched placebo doses Investigators plan to administer one blinded dose per day during the approx 4-month dosing protocol including titration and taper One oral ie edible daily dose will be administered on an outpatient basis Due to DEA regulations eg cannabis is a Schedule I drug with many regulatory restrictions a trained research staff will visit the participant home approx once per week to deliver approx 1-2 week supply of doses Each dose will be locked in its own safe and each safe will have a unique combination code with an AirTag embedded in the safe for dose tracking capabilities if needed
Participants will FaceTime or video chat with a research team member at a pre-specified time every day During this video call the participant will be provided a code to unlock one safe The research staff member will ask the participant to open the safe and show the dose and its label on camera The research staff will verify the correct participant name date and dose code
During this call the research staff will also remind the participant to wear the fitness tracker per protocol so that the study team can monitor vitals HR O2 prior to and for 4 hrs post-dose Participants will also be provided instructions to call the on-call physicianRN if not feeling well or if an alarm on the fitness tracker is received The participant will be required to consume the dose on camera This rationale for verification of dosing is three-fold 1 to ensure no diversion occurs ie the dose is consumed by the patient and not diverted to another person 2 to verify study dosing adherence and 3 to ensure that the correct dose was administered particularly early and late in the study when doses will be titrated and tapered Participants are compensated for compliance with these calls
If a participant has known travel investigators will discuss the travel plans to determine if it is safe and advisable to take doses with them in most scenarios travel with doses will not be likely but this will be discussed at the time of consent and when travel arises In these scenarios or at other times the participant is unavailable eg hospitalized the investigatorsstudy physician will discuss a plan eg not delivering scheduled doses picking up unused doses re-starting a titration schedule if a long break is anticipated discharging from the study as a last resort
Daily assessments for this study include video calls and app-based questionnaires Participants will complete brief daily questionnaires via a smartphone app covering morning assessments of sleep quality hot flashes night sweats appetite nausea pain and overall mood as well as post-dose assessments of drug effects mood and vitals
The in-home visits by a research assistant or nurse will include dose drop-off review of adverse events and addressing any study-related concerns Monthly in-laboratory visits will assess adverse events study progress and continued enrollment with blood draws and other evaluations as scheduled Follow-up assessments will involve weekly app-based questionnaires and a final in-person visit to discuss the study experience collect weight and perform a urine drug screen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None