AzTrials
AzTrials

Breast CarcinomaEarly Phase 1NCT05672342

Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors

A Early Phase 1 study testing Cannabidiol, Delta-8-Tetrahydrocannabinol and Questionnaire Administration in people with Breast Carcinoma and Chemotherapy-Induced Peripheral Neuropathy, run by City of Hope Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This clinical trial tests how well phytocannabinoids (cannabidiol [CBD] and tetrahydrocannbinol [THC]) work in reducing chronic chemotherapy-induced peripheral neuropathy (CIPN) in breast and colon cancer survivors. Neuropathy is the most common neurological symptom reported by cancer patients due to treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cannabidiol, Delta-8-Tetrahydrocannabinol and Questionnaire Administration
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
6 Jul 2024to 31 Oct 2025
Phase
Early Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented informed consent of the participant and/or legally authorized representative
  • Assent, when appropriate, will be obtained per institutional guidelines
  • Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  • If unavailable, exceptions may be granted with study principal investigator (PI) approval
  • Willingness to comply with all study interventions including the use of medical cannabis and follow-up assessments
  • Age: >= 18 years
Show all 17Show fewer
  • Eastern Cooperative Oncology Group (ECOG) =< 2
  • Ability to read and understand English for questionnaires
  • Patients must have either neuropathy >= 1 according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 scale or a neuropathy score of > 3 on a 0-10 scale plus a FACT/GOG-Ntx score of > 10
  • The patient's previous chemotherapy treatment must have included a taxane (paclitaxel, nab-paclitaxel, or docetaxel) or platinum (cisplatin, oxaliplatin, or carboplatin) and considered the primary cause of the neuropathy by the medical team
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)
  • Aspartate aminotransferase (AST) =< 3 x ULN
  • Alanine aminotransferase (ALT) =< 3 x ULN
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 months after the last dose of protocol therapy
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
  • Current active treatment with chemotherapy, radiation or surgery in the past 3 months or planned treatment during this study protocol period. Note: Hormonal therapy is allowed

Who cannot join

  • Concurrent use of other alternative medicines such as medical cannabis, herbal agents and high dose vitamins and minerals
  • Liver cirrhosis Child-Pugh B or C
  • Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry (These patients may not be able to cooperate with this slightly invasive procedure or with the data collection process)
  • History of diabetic neuropathy, neuropathy related to human immunodeficiency virus (HIV), or other medical causes of chronic neuropathy in the baseline assessment including past medical history, any history of diabetes, alcoholism, and vitamin B deficiency
  • Previous medical cannabis use for any indication within 30 days of enrollment
  • Planned or actual changes in type of medications that could affect symptoms related to CIPN. New medications for the treatment of CIPN are not allowed during the study.
Show all 14Show fewer
  • Note: Subjects need to be on stable doses of CIPN medications for 4 weeks
  • Strong inhibitors or inducers of CYP3A4
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
  • Clinically significant uncontrolled illness
  • Diagnosis of Gilbert's disease
  • Females only: Pregnant or breastfeeding
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: A Pilot Study to Evaluate the Benefits of Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy

This clinical trial tests how well phytocannabinoids (cannabidiol [CBD] and tetrahydrocannbinol [THC]) work in reducing chronic chemotherapy-induced peripheral neuropathy (CIPN) in breast and colon cancer survivors. Neuropathy is the most common neurological symptom reported by cancer patients due to treatment. A variety of pharmacologic treatments have been evaluated to alleviate CIPN symptoms; however, no definitive treatment has been found to successfully treat all the symptoms of CIPN. Therefore, investigators continue to seek other possible treatment options including cannabis. Phytocannabinoids may be a particularly useful intervention for cancer patients given the limited effective treatments for CIPN. In addition, cannabis-based medicines have become tremendously popular as both cancer patients and clinicians are seeking therapies with fewer potential risks of dependency and other side effects. This trial is being done to provide cancer patients and clinicians with reliable information to help guide their use of phytocannabinoids to manage the tremendous distress and pain experienced by many cancer patients, which impacts their long-term quality of life.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Assess the ability of CBD and THC:CBD to reduce CIPN symptoms as compared to placebo using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)-Neurotoxicity (Ntx) subscale among breast and colon cancer survivors.

SECONDARY OBJECTIVES:

  1. Evaluate the impact of CBD and THC:CBD as compared to placebo on quality of life using the Functional Assessment of Cancer Therapy General (FACT-G) among breast and colon cancer survivors with chronic CIPN.

II. Document the utilization of neuropathic and pain medications by cancer patients with chronic CIPN during treatment with CBD and THC:CBD as compared to placebo.

III. Describe the side effects of CBD and THC:CBD treatment.

EXPLORATORY OBJECTIVES:

  1. Assess neurological symptoms and function with the Neuropathy Pain Scale (NPS), Total Neuropathy Sccore - clinically based (TNSc), quantitative sensory testing (QST), Grooved Pegboard Test (GPT), and Unipedal Stance balance test (USBT) among patients with chronic CIPN treated with CBD and THC:CBD as compared to placebo.

II. Evaluate for predictors of response to CBD and THC:CBD for chronic CIPN.

OUTLINE: This is a dose-escalation study of CBD and THC. Patients are randomized to 1 of 3 arms.

ARM I: Patients receive CBD orally (PO) on study.

ARM II: Patients receive CBD PO + THC PO on study.

ARM III: Patients receive placebo PO on study.

Being tested
Cannabidiol, Delta-8-Tetrahydrocannabinol, Placebo Administration, Questionnaire Administration
Medical subject headings
Breast Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CannabidiolDrug

    Also called CBD, CBD Oil, Epidiolex, GWP42003-P

    Given PO

  • Delta-8-TetrahydrocannabinolDrug

    Also called .DELTA.8-TETRAHYDROCANNABINOL, delta-8-THC

    Given PO

  • Placebo AdministrationDrug

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT05672342
Study groupRoleWhat they receive
Arm I (CBD)ExperimentalPatients receive CBD PO on study.
Receives: Drug: Cannabidiol; Other: Questionnaire Administration
Arm II (CBD + THC)ExperimentalPatients receive CBD PO + THC PO on study.
Receives: Drug: Cannabidiol; Drug: Delta-8-Tetrahydrocannabinol; Other: Questionnaire Administration
Arm III (placebo)Placebo comparatorPatients receive placebo PO on study.
Receives: Drug: Placebo Administration; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)-Neurotoxicity (Ntx) subscale scores

    The primary analysis will compare difference in scores from the FACT/GOG-Ntx between all groups using analysis of variance, and a repeated measures analysis of variance analysis will be performed. Multivariable mixed-effects regression model which takes possible dependence of longitudinal measurements within each subject into account, will be used. In addition, a paired t-test will be utilized to compare scores between baseline and 8 and 12 weeks of treatment for each group separately.

    Measured: Baseline up to week 12

Secondary outcomes (3)

  1. Quality of life by the Functional Assessment of Cancer Therapy-General (FACT-G) scores

    The pre-treatment values recorded from the FACT-G will be considered the baseline scores. A paired T-test will be utilized to compare scores between baseline and 8 weeks of treatment. For comparisons between groups at four specific assessment points (baseline, week 4, week 8, and week 12), a repeated measures analysis of variance analysis will be performed

    Measured: Up to 12 weeks

  2. Utilization of neuropathic and pain medications

    Medication data will initially be analyzed as a dichotomous variable (yes/no) for each medication. These medications may include neuropathic medications (e.g., gabapentin, pregabalin, duloxetine, amitriptyline), Non-steroidal anti-inflammatory drugs, acetaminophen, opioid medications (e.g., morphine, oxycodone), or other related medications. Comparisons between the baseline and after-treatment medication status will be analyzed using McNemar's test. Including all the time points in the analysis of any single medication will use Cochran's Q test. The usage of multiple medications will be summarized descriptively to determine the best way to quantify multiple use, such as counts or categorized quantities. McNemar's test will be used to detect change in the level of medication use.

    Measured: Up to 12 weeks

  3. Incidents of adverse events

    All adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0. The severe adverse events (SAE) (grade >= 3) will be tabulated per treatment arm and the difference of SAE will be compared among groups using chi-square test.

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2023
  2. Study start6 Jul 2024 (estimated)
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Why it stopped: withdrawn

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05672342
Sponsor's protocol ID
22339
Other IDs
NCI-2022-10253, 22339, P30CA033572, R21CA260447
Status last verified
Aug 2024
First submitted
3 Jan 2023
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Cannabidiol, Delta-8-Tetrahydrocannabinol and Questionnaire Administration in people with Breast Carcinoma and Chemotherapy-Induced Peripheral Neuropathy, run by City of Hope Medical Center 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 17 inclusion and 14 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: withdrawn, as of the sponsor's last update on 9 Aug 2024. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Difference in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)-Neurotoxicity (Ntx) subscale scores (time frame: Baseline up to week 12). 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 NCT05672342.

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 9 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in