Chemotherapy-induced Peripheral NeuropathyPhase 2Coala-T-CBDNCT04398446
Effect of Hemp-CBD on Patients With CIPN
A Phase 2 study testing Hemp-based CBD in people with Chemotherapy-induced Peripheral Neuropathy and Colorectal Cancer Stage II, run by Main Line Health at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of a hemp-based cannabidiol (CBD) product, Ananda Hemp Spectrum Gelcaps, on the severity and duration of chemotherapy-induced neuropathy (CIPN) among non-metastatic breast, uterine, pancreatic, and colorectal cancer, and all stages of ovarian cancer in patients who… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, Colorectal Cancer Stage II, Colorectal Cancer Stage III
- What is being tested?
- Hemp-based CBD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2020to 1 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-metastatic breast cancer patients who developed CIPN (CTCAE sensory grade 2 or 3, motor grade <2) after receiving taxane-based chemotherapy in pre-operative or post-operative setting.
- Non-metastatic Colorectal cancer patients with high risk stage II and stage III disease who developed CIPN (CTCAE sensory grade 2 or 3, motor grade <2) after receiving oxaliplatin in the adjuvant setting.
- Ovarian cancer patients who developed CIPN (CTCAE sensory grade 2 or 3, motor grade <2) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting .
- Uterine cancer patients who developed CIPN (CTCAE grade 2 or 3) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting.
- Non-metastatic pancreatic cancer patients who developed CIPN (CTCAE grade 2 or 3) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting.
Who cannot join
- Family history of genetic/familial neuropathy
- Routine use of recreational or medicinal marijuana products (defined as > 4 times per month) or illicit drug use (positive urine drug screen including opioids, cocaine, amphetamines, PCP, LSD)
- Known underlying liver disease (Child-Pugh B or C) or baseline elevation in ALT, AST or total bilirubin ≥1.5 x upper limit of normal
- Patients taking certain medications will be excluded due to potential CBD-drug interaction. CBD may prevent appropriate drug metabolism increasing risk for toxicity. Co-administration of study product and the following medications will be contraindicated and may lead to participant exclusion: clarithromycin, itraconazole, erythromycin, fluconazole, clopidogrel, rifampin, sulfamethoxazole, warfarin, any opioids, warfarin, antiepileptic medications (including carbamazapine, phenytoin, valproic acid, but excepting of gabapentin, clonazepam or diazepam).
- Underlying history of epilepsy/ recurrent seizure disorder or unexplained seizure within past 6 months
- Patients with uncontrolled cardiovascular disease defined by myocardial infarction, stroke or transient ischemic attack, or need for coronary stent placement within past six months.
- Patients with uncontrolled psychiatric illness (who meet DSM-V criteria) or who are at increased risk for suicidality based on baseline Columbia-Suicide Severity Rating Scale.
- Women who are pregnant or breastfeeding or who refuse to practice an effective form of birth control (condoms, diaphragm, birth control pill, IUD)
Trial locations and contacts
1 site in 1 country.
United States1 site
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: Coala-T-CBD Study: A Study of the Effect of Hemp-CBD on the Severity and Duration of Chemotherapy-Induced Peripheral Neuropathy in Patients Receiving Neurotoxic Chemotherapy for Non-Metastatic Breast, Uterine, Pancreatic, and Colorectal Cancer and All Stages of Ovarian Cancer
The purpose of this study is to assess the effect of a hemp-based cannabidiol (CBD) product, Ananda Hemp Spectrum Gelcaps, on the severity and duration of chemotherapy-induced neuropathy (CIPN) among non-metastatic breast, uterine, pancreatic, and colorectal cancer, and all stages of ovarian cancer in patients who received neoadjuvant or adjuvant therapy that included neurotoxic chemotherapeutic agents.
Read the detailed description
CIPN is a common complication of many effective cytotoxic agents that can negatively impact patients' treatment course and quality of life. The incidence of CIPN in cancer patients receiving multidrug regimens is estimated at 38%, with frequencies approaching 100% with certain known neurotoxic drug classes. Taxanes (e.g., paclitaxel, docetaxel) and platinum-based agents (e.g., oxaliplatin, cisplatin, carboplatin) in particular, are two commonly used chemotherapy classes that are associated with a high incidence of CIPN. Symptoms of chemotherapy-induced peripheral neuropathy include distal extremity numbness, tingling and pain. Chronic, cumulative symptoms can severely impact quality of life and result in dose reductions and/or drug discontinuation in up to 30% of patients.
Consumers use cannabis products for various reasons including pain, stress, anxiety, and insomnia. The neuro-modulatory effects of phytocannabinoids, tetrahydrocannabinol (THC) and cannabidiol (CBD) in particular, have been documented at both the molecular and clinical level. The endocannabinoid system consists of CB1 receptors and CB2 receptors that act as an inhibitory G-protein within the central and peripheral nervous system, respectively. Several animal models have demonstrated the role endocannabinoids play in neuropathic pain development by showing enhanced neuropathic pain with CB1 receptor deletion and reduced manifestations of neuropathic pain with CB2 receptor overexpression. The therapeutic properties of cannabis-based products have also been illustrated in several randomized double-blind trials that have shown significant pain relief versus placebo in the treatment of neuropathy related to diabetes, spinal cord injury, multiple sclerosis, and HIV associated polyneuropathy. Studies specifically looking at the role of CBD in chemotherapy-induced neurotoxicity have shown a neuroprotective effect of CBD in mouse models. Studies have demonstrated that a 14-day dosing regimen of CBD prevented the onset of paclitaxel-induced mechanical and thermal sensitivity.
These intriguing results suggest that cannabinoid agents could potentially reduce the severity and duration of CIPN in the clinical setting.
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Colorectal Cancer Stage II, Colorectal Cancer Stage III, Breast Cancer, Ovarian Cancer, Uterine Cancer
- Being tested
- Hemp-based CBD, Placebo oral tablet
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemp-based CBDDrug
Also called Ananda Hemp CBD Spectrum Gelcaps
3x Daily dosing for 12 weeks
Placebo oral tabletOther
3x Daily dosing for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hemp-based CBD | Experimental | Not described Receives: Drug: Hemp-based CBD |
| Placebo Oral Tablet | Placebo comparator | Not described Receives: Other: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pressure/touch sensation during intervention and at follow-up
At regular intervals, CIPN will be assessed by Semmes Weinstein Monofilament Examination using Touch-Test Sensory Evaluator Kit to determine pressure sensation.
Measured: Every two weeks for twelve weeks during intervention; One month follow-up
Change in pain sensation during intervention and at follow-up
At regular intervals, CIPN will be assessed by pinprick examination to determine pain sensation.
Measured: Every two weeks for twelve weeks during intervention; One month follow-up
Change in vibration sensation during intervention and at follow-up
At regular intervals, CIPN will be assessed by 128Hz tuning fork vibration test to determine vibration sensation.
Measured: Every two weeks for twelve weeks during intervention; One month follow-up
Change in quality of life
Quality of life will be measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire, a validated 30-item questionnaire to assess treatment impact on quality of life in cancer patients on 4-point scales, where 4 is most severe.
Measured: Every two weeks for twelve weeks during intervention; One month follow-up
Change in CIPN symptom severity
CIPN symptoms will be measured by EORTC QLQ-CIPN20 Questionnaire, validated 20-item questionnaire to assess symptom severity of chemotherapy-induced peripheral neuropathy on 4-point scales, where 4 is most severe.
Measured: Every two weeks for twelve weeks during intervention; One month follow-up
Change in pain severity
Pain severity will be measured by Brief Pain Inventory (BPI) Short Form, validated 9-item questionnaire to assess the severity of pain and the impact of pain on daily functions on 10-point scales, where 10 is most severe.
Measured: Every two weeks for twelve weeks during intervention; One month follow-up
Change in sleep quality
Sleep quality will be measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire, validated 8-item questionnaire to assess sleep quality on 5-point scales, where 5 is the most severe.
Measured: Every two weeks for twelve weeks during intervention; One month follow-up
Secondary outcomes (3)
Receptivity and accrual rate to clinical studies involving cannabis-based substances.
Receptivity to clinical trials as well as to the use of CBD will be assessed using a questionnaire that will be distributed to all patients at the first encounter. Responses to this questionnaire will provide information regarding in the use of CBD was influencing factor for those who chose to participate or deferring factor for those who decline participation.
Measured: 1 Day
Adherence to CBD Products
Adherence will be assessed with a Dosing Diary.
Measured: Daily, 12 weeks
Rate of side effects using medical-grade CBD concentrates
Side effects will be assessed at each encounter clinical evaluation by patient report in a Dosing Diary. All side effects thought to be secondary to CBD will be documented.
Measured: Daily, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start27 May 2020
- Primary completion30 Nov 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Main Line Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ananda Hemp, Inc.
- Responsible party
- Principal investigator, Dr. Marisa Weiss, Main Line Health
- Investigators
- Marisa Weiss, MD, Principal investigator, Main Line Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398446
- Sponsor's protocol ID
- F/N-R19-3893L
- Acronym
- Coala-T-CBD
- Status last verified
- Aug 2022
- First submitted
- 23 Apr 2020
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee G, Grovey B, Furnish T, Wallace M. Medical Cannabis for Neuropathic Pain. Curr Pain Headache Rep. 2018 Feb 1;22(1):8. doi: 10.1007/s11916-018-0658-8.
PubMed 29388063Brzezinski K. Chemotherapy-induced polyneuropathy. Part I. Pathophysiology. Contemp Oncol (Pozn). 2012;16(1):72-8. doi: 10.5114/wo.2012.27341. Epub 2012 Feb 29.
PubMed 23788859Brzezinski K. Chemotherapy-induced peripheral neuropathy. Part II. Prevention. Contemp Oncol (Pozn). 2012;16(3):258-61. doi: 10.5114/wo.2012.29296. Epub 2012 Jul 6.
PubMed 23788891Saif MW, Reardon J. Management of oxaliplatin-induced peripheral neuropathy. Ther Clin Risk Manag. 2005 Dec;1(4):249-58.
PubMed 18360567Wang WS, Lin JK, Lin TC, Chen WS, Jiang JK, Wang HS, Chiou TJ, Liu JH, Yen CC, Chen PM. Oral glutamine is effective for preventing oxaliplatin-induced neuropathy in colorectal cancer patients. Oncologist. 2007 Mar;12(3):312-9. doi: 10.1634/theoncologist.12-3-312.
PubMed 17405895Ward SJ, Ramirez MD, Neelakantan H, Walker EA. Cannabidiol prevents the development of cold and mechanical allodynia in paclitaxel-treated female C57Bl6 mice. Anesth Analg. 2011 Oct;113(4):947-50. doi: 10.1213/ANE.0b013e3182283486. Epub 2011 Jul 7.
PubMed 21737705
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coala-T-CBD Study: A Study of the Effect of Hemp-CBD on the Severity and Duration of Chemotherapy-Induced Peripheral Neuropathy in Patients Receiving Neurotoxic Chemotherapy for Non-Metastatic Breast, Uterine, Pancreatic, and Colorectal Cancer and All Stages of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04398446
- Acronym / sponsor ID
- Coala-T-CBD / F/N-R19-3893L
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Colorectal Cancer Stage II, Colorectal Cancer Stage III, Breast Cancer, Ovarian Cancer, Uterine Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Main Line HealthUniversity, hospital or other
- Collaborators
- Ananda Hemp, Inc.
- Study start
- 27 May 2020 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of a hemp-based cannabidiol (CBD) product, Ananda Hemp Spectrum Gelcaps, on the severity and duration of chemotherapy-induced neuropathy (CIPN) among non-metastatic breast, uterine, pancreatic, and colorectal cancer, and all stages of ovarian cancer in patients who received neoadjuvant or adjuvant therapy that included neurotoxic chemotherapeutic agents.
Detailed description
CIPN is a common complication of many effective cytotoxic agents that can negatively impact patients' treatment course and quality of life. The incidence of CIPN in cancer patients receiving multidrug regimens is estimated at 38%, with frequencies approaching 100% with certain known neurotoxic drug classes. Taxanes (e.g., paclitaxel, docetaxel) and platinum-based agents (e.g., oxaliplatin, cisplatin, carboplatin) in particular, are two commonly used chemotherapy classes that are associated with a high incidence of CIPN. Symptoms of chemotherapy-induced peripheral neuropathy include distal extremity numbness, tingling and pain. Chronic, cumulative symptoms can severely impact quality of life and result in dose reductions and/or drug discontinuation in up to 30% of patients.
Consumers use cannabis products for various reasons including pain, stress, anxiety, and insomnia. The neuro-modulatory effects of phytocannabinoids, tetrahydrocannabinol (THC) and cannabidiol (CBD) in particular, have been documented at both the molecular and clinical level. The endocannabinoid system consists of CB1 receptors and CB2 receptors that act as an inhibitory G-protein within the central and peripheral nervous system, respectively. Several animal models have demonstrated the role endocannabinoids play in neuropathic pain development by showing enhanced neuropathic pain with CB1 receptor deletion and reduced manifestations of neuropathic pain with CB2 receptor overexpression. The therapeutic properties of cannabis-based products have also been illustrated in several randomized double-blind trials that have shown significant pain relief versus placebo in the treatment of neuropathy related to diabetes, spinal cord injury, multiple sclerosis, and HIV associated polyneuropathy. Studies specifically looking at the role of CBD in chemotherapy-induced neurotoxicity have shown a neuroprotective effect of CBD in mouse models. Studies have demonstrated that a 14-day dosing regimen of CBD prevented the onset of paclitaxel-induced mechanical and thermal sensitivity.
These intriguing results suggest that cannabinoid agents could potentially reduce the severity and duration of CIPN in the clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemp-based CBD | Experimental | Drug: Hemp-based CBD |
| Placebo Oral Tablet | Placebo comparator | Other: Placebo oral tablet |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-metastatic breast cancer patients who developed CIPN (CTCAE sensory grade 2 or 3, motor grade <2) after receiving taxane-based chemotherapy in pre-operative or post-operative setting.
- Non-metastatic Colorectal cancer patients with high risk stage II and stage III disease who developed CIPN (CTCAE sensory grade 2 or 3, motor grade <2) after receiving oxaliplatin in the adjuvant setting.
- Ovarian cancer patients who developed CIPN (CTCAE sensory grade 2 or 3, motor grade <2) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting .
- Uterine cancer patients who developed CIPN (CTCAE grade 2 or 3) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting.
- Non-metastatic pancreatic cancer patients who developed CIPN (CTCAE grade 2 or 3) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting.
Key exclusion criteria (8 listed)
- Family history of genetic/familial neuropathy
- Routine use of recreational or medicinal marijuana products (defined as > 4 times per month) or illicit drug use (positive urine drug screen including opioids, cocaine, amphetamines, PCP, LSD)
- Known underlying liver disease (Child-Pugh B or C) or baseline elevation in ALT, AST or total bilirubin ≥1.5 x upper limit of normal
- Patients taking certain medications will be excluded due to potential CBD-drug interaction. CBD may prevent appropriate drug metabolism increasing risk for toxicity. Co-administration of study product and the following medications will be contraindicated and may lead to participant exclusion: clarithromycin, itraconazole, erythromycin, fluconazole, clopidogrel, rifampin, sulfamethoxazole, warfarin, any opioids, warfarin, antiepileptic medications (including carbamazapine, phenytoin, valproic acid, but excepting of gabapentin, clonazepam or diazepam).
- Underlying history of epilepsy/ recurrent seizure disorder or unexplained seizure within past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemp-based CBDAlso: Ananda Hemp CBD Spectrum Gelcaps3x Daily dosing for 12 weeks | Drug | Hemp-based CBD |
| Placebo oral tablet3x Daily dosing for 12 weeks | Other | Placebo Oral Tablet |
Primary outcome
Change in pressure/touch sensation during intervention and at follow-up
Time frame: Every two weeks for twelve weeks during intervention; One month follow-up
At regular intervals, CIPN will be assessed by Semmes Weinstein Monofilament Examination using Touch-Test Sensory Evaluator Kit to determine pressure sensation.
Change in pain sensation during intervention and at follow-up
Time frame: Every two weeks for twelve weeks during intervention; One month follow-up
At regular intervals, CIPN will be assessed by pinprick examination to determine pain sensation.
Change in vibration sensation during intervention and at follow-up
Time frame: Every two weeks for twelve weeks during intervention; One month follow-up
At regular intervals, CIPN will be assessed by 128Hz tuning fork vibration test to determine vibration sensation.
Change in quality of life
Time frame: Every two weeks for twelve weeks during intervention; One month follow-up
Quality of life will be measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire, a validated 30-item questionnaire to assess treatment impact on quality of life in cancer patients on 4-point scales, where 4 is most severe.
Change in CIPN symptom severity
Time frame: Every two weeks for twelve weeks during intervention; One month follow-up
CIPN symptoms will be measured by EORTC QLQ-CIPN20 Questionnaire, validated 20-item questionnaire to assess symptom severity of chemotherapy-induced peripheral neuropathy on 4-point scales, where 4 is most severe.
Change in pain severity
Time frame: Every two weeks for twelve weeks during intervention; One month follow-up
Pain severity will be measured by Brief Pain Inventory (BPI) Short Form, validated 9-item questionnaire to assess the severity of pain and the impact of pain on daily functions on 10-point scales, where 10 is most severe.
Change in sleep quality
Time frame: Every two weeks for twelve weeks during intervention; One month follow-up
Sleep quality will be measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire, validated 8-item questionnaire to assess sleep quality on 5-point scales, where 5 is the most severe.
3 secondary outcomes
Receptivity and accrual rate to clinical studies involving cannabis-based substances.
Time frame: 1 Day
Adherence to CBD Products
Time frame: Daily, 12 weeks
Rate of side effects using medical-grade CBD concentrates
Time frame: Daily, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Background: PubMed 29388063Lee G, Grovey B, Furnish T, Wallace M. Medical Cannabis for Neuropathic Pain. Curr Pain Headache Rep. 2018 Feb 1;22(1):8. doi: 10.1007/s11916-018-0658-8.
- Background: PubMed 23788859Brzezinski K. Chemotherapy-induced polyneuropathy. Part I. Pathophysiology. Contemp Oncol (Pozn). 2012;16(1):72-8. doi: 10.5114/wo.2012.27341. Epub 2012 Feb 29.
- Background: PubMed 23788891Brzezinski K. Chemotherapy-induced peripheral neuropathy. Part II. Prevention. Contemp Oncol (Pozn). 2012;16(3):258-61. doi: 10.5114/wo.2012.29296. Epub 2012 Jul 6.
- Background: PubMed 18360567Saif MW, Reardon J. Management of oxaliplatin-induced peripheral neuropathy. Ther Clin Risk Manag. 2005 Dec;1(4):249-58.
- Background: PubMed 17405895Wang WS, Lin JK, Lin TC, Chen WS, Jiang JK, Wang HS, Chiou TJ, Liu JH, Yen CC, Chen PM. Oral glutamine is effective for preventing oxaliplatin-induced neuropathy in colorectal cancer patients. Oncologist. 2007 Mar;12(3):312-9. doi: 10.1634/theoncologist.12-3-312.
- Background: PubMed 21737705Ward SJ, Ramirez MD, Neelakantan H, Walker EA. Cannabidiol prevents the development of cold and mechanical allodynia in paclitaxel-treated female C57Bl6 mice. Anesth Analg. 2011 Oct;113(4):947-50. doi: 10.1213/ANE.0b013e3182283486. Epub 2011 Jul 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marisa Weiss, MD principal investigator
Main Line Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hemp-based CBD in people with Chemotherapy-induced Peripheral Neuropathy and Colorectal Cancer Stage II, run by Main Line Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pressure/touch sensation during intervention and at follow-up (time frame: Every two weeks for twelve weeks during intervention; One month follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04398446, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.