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Cannabis oil trial aims to ease cancer Patients' daily suffering

NCT ID NCT07459920

Symptom relief Sponsor: National Cancer Institute, Naples Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a cannabis extract oil containing THC and CBD can reduce the overall symptom burden in people with advanced solid tumors who are already taking strong painkillers. About 156 participants will receive either the cannabis oil or a placebo for 8 weeks. The main goal is to see if the cannabis oil improves total symptom scores, including pain, nausea, and fatigue.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cannabis extract oil (10 mg/ml THC and 10 mg/ml CBD)
What this could lead to
If it works, this could offer a new way to reduce multiple symptoms like pain, nausea, and poor appetite in advanced cancer patients.
What could go wrong
This is a phase 2 trial with only 156 people, so results are preliminary. The cannabis extract may cause side effects like dizziness or drowsiness, and it might not improve symptoms more than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 156 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Written informed consent 2. Individuals of any sex, gender, sexual orientation, and ethnicity aged 18 or over 3. No previous use of Cannabis in the last 6 months 4. Patients with advanced oncological neoplasia with a life expectancy of at least 6 months on active antineoplastic treatment and with a compromised quality of life defined by at least one of the following criteria: 1. presence of physical symptoms, such as moderate or severe pain, nausea, vomiting, loss of appetite 2. presence of psychological symptoms, such as anxiety, depression and insomnia 5. ECOG ≤ 3 6. ESAS-TSDS score ≥ 16 7. Patients on stable therapy with "Level II" or Level III" opioids according to the WHO analgesic scale and/or with adjuvants 8. Women of childbearing age (Women Of Child Bearing Potential, WOCBP) are eligible for the study only if: 1. Negative pregnancy test 2. Willingness to use effective contraception (concurrent use of two methods with a Pearl Index \< 1%) during treatment and for at least 3 months after the last dose of the investigational product. 9. Male participants with partners of childbearing potential must agree to use condoms (with spermicide, if available) in combination with an additional highly effective contraceptive method used by their partner, during treatment period and for at least 3 months after the last dose of the investigational product. Exclusion Criteria: * 1\. Inability to understand and complete the questionnaires required by the study 2. Known hypersensitivity/allergy to THC or CBD 3. Psychiatric illness related to schizophrenia/psychosis 4. Personal history of any type of addiction 5. Pregnancy / breastfeeding 6. PEG feeding 7. Any other medical condition that, in the opinion of the physician, would affect the participant's safety or ability to comply with the study protocol 8. Concurrent participation in other clinical studies started less than 30 days ago

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Conditions

The condition(s) this trial relates to.

cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced malignant solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS Fondazione G. Pascale

    Naples, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.