Medical Cannabis for Nausea in Patients Receiving Moderately or Highly Emetogenic Chemotherapy

University of Rochester

Status and phase: Begins enrollment this month; Phase 2

Conditions: Nausea and Vomiting Chemotherapy-Induced

Treatments: Drug: Medical Cannabis

Study type: Interventional

Funder types: Other

Identifiers

NCT07374939

STUDY00011238

Details and patient eligibility

About

Many people receiving chemotherapy experience nausea despite standard anti-nausea medications. Medical cannabis is commonly used to help manage nausea, but there is limited scientific evidence about its effectiveness when used alongside modern chemotherapy treatments.

This study will evaluate whether medical cannabis can reduce nausea in adults receiving moderately or highly nausea-causing chemotherapy. Participants will be randomly assigned to start medical cannabis either immediately or after one chemotherapy cycle, allowing comparison of symptoms with and without cannabis use. All participants will continue their usual anti-nausea medications.

The study will also examine effects on vomiting, appetite, pain, fatigue, sleep, mood, quality of life, and inflammation. Results from this pilot study will help determine the safety, feasibility, and potential benefits of medical cannabis for chemotherapy-related nausea and guide future larger clinical trials.

Full description

Many people receiving chemotherapy experience nausea, even when they are given standard anti-nausea medications. Vomiting is now often well controlled, but nausea, especially nausea that occurs one or more days after chemotherapy, remains a major problem. Nausea can interfere with daily activities, reduce appetite, worsen quality of life, and sometimes lead to dehydration or delays in cancer treatment. New approaches are needed to better manage chemotherapy-related nausea.

Medical cannabis is commonly used by patients to help with nausea, appetite, sleep, pain, and other treatment-related symptoms. Although cannabis is legal for medical use in many U.S. states and cancer is a qualifying condition, there is limited scientific evidence about how well cannabis works for chemotherapy-related nausea when used alongside modern anti-nausea medications. More research is needed to understand its benefits, risks, and how it may best be used.

The purpose of this study is to collect early (pilot) data on whether medical cannabis can reduce nausea in adults receiving moderately or highly nausea-causing chemotherapy. The study will also examine whether cannabis affects vomiting, appetite, fatigue, sleep, pain, nerve pain, mood, and quality of life. In addition, blood samples will be collected to explore whether cannabis is associated with changes in inflammation related to cancer treatment.

About 50 adults with cancer who are receiving chemotherapy will take part in this study at the University of Rochester Medical Center. Participants must be 21 years of age or older, experiencing significant nausea despite standard anti-nausea medications, and receiving chemotherapy that commonly causes nausea. People with certain medical or psychiatric conditions, recent cannabis use, or lung disease will not be eligible for safety reasons.

Participants will be randomly assigned to one of two groups. One group will begin using medical cannabis during their first study chemotherapy cycle, while the other group will continue usual care for one cycle and then begin using medical cannabis during the next cycle. This delayed-start approach allows each participant to be compared to their own experience before and after cannabis use. All participants will continue to receive their prescribed anti-nausea medications throughout the study.

Medical cannabis will be obtained through a state-licensed dispensary and used primarily during the four days surrounding each chemotherapy treatment, when nausea is most likely to occur. Cannabis will be used with a standardized vaporization device to help ensure consistent dosing. Participants will keep daily diaries to record nausea, vomiting, cannabis use, and any side effects. They will also complete questionnaires about symptoms, mood, and quality of life. Blood samples will be collected once per chemotherapy cycle during routine lab visits.

Possible risks include side effects of cannabis such as dizziness, anxiety, sleepiness, or difficulty concentrating, as well as minor risks from blood draws such as bruising or lightheadedness. Participants will be given safety instructions, including avoiding driving after cannabis use. There may or may not be direct benefit to participants, but the information gained may help improve nausea management for future cancer patients.

This study will provide important early evidence about the safety, feasibility, and potential benefits of medical cannabis for chemotherapy-related nausea and related symptoms, and will help guide larger future clinical trials.

Enrollment: 50 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a diagnosis of cancer with no previous chemotherapy treatments (aside from current treatment)

• Be scheduled to receive treatment with a chemotherapeutic agent that is classified by the National Comprehensive Cancer Network (NCCN) as having a high emetogenic potential (>90% incidence) or moderate emetogenic potential (30-90% incidence).

• Must be scheduled for a minimum of 3 additional chemotherapy cycles at the time of enrollment.

• Chemotherapy agents may be given intravenously or orally.

• Chemotherapy cycles must be at least two weeks apart.

• For the purposes of this study, Day 1 is defined as the day of chemotherapy administration.

• Chemotherapy may be for adjuvant, neoadjuvant, curative, or palliative intent.

• Highly emetogenic - common types of chemotherapy

  • AC combination defined as any chemotherapy regimen that contains an anthracycline and cyclophosphamide
  • Carboplatin AUC ≥4
  • Carmustine >250 mg/m2
  • Cisplatin
  • Cyclophosphamide >1,500 mg/m2
  • Dacarbazine
  • Doxorubicin ≥60 mg/m2
  • Epirubicin >90 mg/m2
  • Ifosfamide ≥2 g/m2 per dose
  • Mechlorethamine
  • Streptozocin

• Moderately emetogenic - common types of chemotherapy:

  • Aldesleukin >12-15 million IU/m2
  • Amifostine >300 mg/m2
  • Arsenic trioxide
  • Azacitidine
  • Bendamustine
  • Busulfan
  • Carboplatin AUC <4
  • Carmustined ≤250 mg/m2
  • Clofarabine
  • Cyclophosphamide ≤1500 mg/m2
  • Cytarabine >200 mg/m2
  • Dactinomycin
  • Daunorubicin
  • Dual-drug liposomal encapsulation of cytarabine and daunorubicin
  • Dinutuximab
  • Doxorubicind <60 mg/m2
  • Epirubicind ≤90 mg/m2
  • Idarubicin
  • Ifosfamided <2 g/m2 per dose
  • Interferon alfa ≥10 million IU/m2
  • Irinotecan
  • Irinotecan (liposomal)
  • Melphalan
  • Methotrexated ≥250 mg/m2
  • Oxaliplatin
  • Temozolomide
  • Trabectedin

• Be willing to commit to the suggested medication dosing and delivery method, completing evaluation instruments, and attending all study visits.

• Be able to understand English (all assessment instruments are in English).

• Be 21 years of age or older.

• Give informed consent.

• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, or abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.

Exclusion criteria

• Participants must not:
• Use of any THC-containing cannabis products within 30 days prior to enrollment, verified by participant self-report.

Allowable: Use of hemp-derived CBD products containing < 0.3 % THC is permitted, consistent with the 2018 Agriculture Improvement Act (federal definition of hemp). Use of CBD products will be documented in baseline case report forms.

• Have any allergies to cannabis or contraindication for cannabis.
• Have an active or recent (< 6 months) substance use disorder, as determined by medical history.
• Have recently quit smoking (< 6 months) or are actively engaged in a smoking-cessation program.
• Have a history of severe anxiety or paranoia on prior exposure to cannabis.
• Have a previous diagnosis of bipolar disorder or schizophrenia.
• Be pregnant or nursing.
• Have had a prior stroke.
• Have moderate or severe chronic obstructive pulmonary disease (COPD), defined as FEV₁ < 50 % predicted or current use of home supplemental oxygen.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Immediate use

Experimental group

Description:

Participants randomized to the Immediate Use arm will receive New York State medical cannabis certification and initiate medical cannabis use during their first on-study chemotherapy cycle, in addition to standard guideline-recommended antiemetic therapy. Participants will use medical cannabis primarily during the four days surrounding chemotherapy administration, corresponding to the acute and delayed nausea period. Cannabis will be administered by vaporization using a standardized device, dose limits, and schedule. Participants will complete daily nausea and vomiting diaries, cannabis use logs, and symptom questionnaires, and will provide blood samples once per chemotherapy cycle. Outcomes in this arm will be compared to the delayed-use arm to evaluate the preliminary efficacy, safety, and feasibility of medical cannabis for chemotherapy-related nausea.

Treatment:

Drug: Medical Cannabis

Delayed use

Active Comparator group

Description:

Participants randomized to the Delayed Use arm will receive standard guideline-recommended antiemetic therapy alone during their first on-study chemotherapy cycle and will not use medical cannabis during this initial evaluation period. This cycle will serve as the comparison condition for nausea outcomes. After completion of the first cycle assessments, participants will receive New York State medical cannabis certification and will initiate medical cannabis use during the subsequent chemotherapy cycle. Cannabis will be administered by vaporization using a standardized device, dose limits, and schedule, primarily during the four days surrounding chemotherapy administration. Participants will complete daily nausea and vomiting diaries, cannabis use logs, symptom questionnaires, and provide blood samples once per chemotherapy cycle to evaluate changes after cannabis initiation.

Treatment:

Drug: Medical Cannabis