Abstract
Cannabis use for symptom management among patients with cancer has increased in recent years, with many reporting benefits for pain, anxiety, sleep, nausea, and appetite, as well as other symptoms. However, rigorous prospective data on the potential benefits and harms of cannabis use in this population are lacking. This commentary describes a US National Cancer Institute–led initiative addressing this research gap by supporting 5 prospective observational studies evaluating the benefits and harms of cannabis use among a large heterogeneous sample of patients with cancer undergoing active systemic treatment. We provide an overview of each study, including cancer type, treatment modalities, inclusion and exclusion criteria, data collection methods, and patient-reported and cancer-related outcomes.
Cannabis use among patients with cancer is on the rise
Cancer is a qualifying condition for medical cannabis certification in most of the 38 states and 3 territories that have legalized medical cannabis.1 A growing number of individuals with cancer are using cannabis at some point after their diagnosis, with estimates ranging from 8% to nearly 50%, depending on the legal status of the geographic area.2 More than 90% of cancer survivors view cannabis as potentially beneficial for symptom management and support its legalization.3 Among cancer survivors who use cannabis, approximately 75% report using it primarily for symptom management, most commonly for pain, nausea, and sleep disturbances.4,5
State of the science on cannabis use among patients with cancer
Despite the increasing acceptability and use of cannabis, data on its safety and effectiveness to treat cancer-related symptoms remain limited. A lack of robust data exists on patterns of cannabis use for symptom management, including modality and dose, and limited evidence regarding its safety and efficacy for most cancer-related side effects. With states legalizing cannabis at a rapid pace with varying regulations, limited product standards and few marketing restrictions, and the increasing use of cannabis by cancer patients, strong scientific evidence is critically needed to better understand the benefits and harms of the variety of cannabis products patients are procuring. In 2024, the American Society of Clinical Oncology (ASCO) released the Cannabis and Cannabinoids for Adults with Cancer guideline. The guideline summarized 13 systematic reviews on cannabis and cannabinoids use for cancer treatment–related symptoms and anticancer properties and defined cannabis and cannabinoids broadly, including plant based or synthetic (dronabinol, nabiximols). Within the ASCO recommendation, there is limited evidence that cannabis can relieve cancer treatment side effects, including sleep, quality of life, mood, poor appetite, and pain. There was moderate strength evidence, however, that a pharmaceutically prepared nabiximols could reduce pain.6,7 There was also moderate strength evidence for the use of 2 preparations (nabiximols, dronabinol) to reduce chemotherapy-induced nausea and vomiting. ASCO recommends against using high-dose cannabidiol (CBD) to reduce total cancer symptom burden. Given the lack of data to support cannabis use and the high prevalence of cannabis use among this population, ASCO first recommends clinicians routinely ask, in a nonjudgmental way, about cancer patient cannabis use to engage in informed decision making and goal setting.8 However, most patients obtain advice from local cannabis dispensaries rather than their oncology providers.7 Almost 50% of oncologists recommend cannabis for their patients, but less than 30% feel sufficiently informed to make specific recommendations.8,9 Thus, there is an urgent need for more research to guide patients and providers on the optimal use of cannabis in oncology care.10,11
Regarding the potential harms of cannabis and cannabinoids, the ASCO guideline suggests common side effects, not specific to cancer populations, include dizziness, fatigue, confusion, dry mouth, and vomiting, while more serious harms such as increased anxiety, risk of psychosis, motor vehicle accidents, and risk of fall have been described. Moreover, among cancer survivors, there is potential for interaction with cancer treatment. For example, 3 recent observational studies demonstrate that cancer patients using cannabis during immunotherapy had a shorter time to tumor progression and/or lower overall survival,12–14 yet many other gaps remain in our understanding of these health risks among those with cancer. Importantly, cannabis use to mitigate cancer-related symptoms, such as pain or loss of appetite, in patients undergoing immunotherapy has been associated with these negative outcomes. However, it remains unclear whether these associations are causal, whether they apply to patients with prior regular cannabis use (recreational or for noncancer conditions), or whether they extend to other cancer treatment modalities, such as chemotherapy. This highlights the critical need to study cannabis use patterns and trajectories to better understand where cannabis may be beneficial or harmful. Similarly, major cannabinoids, such as CBD, affect liver function at therapeutic doses,15 which could potentially interfere with the metabolism of chemotherapeutic agents metabolized in the liver, such as paclitaxel or vincristine.16 Additionally, certain chemo-therapies, including paclitaxel, alter liver enzyme function,17,18 while immunotherapeutics, such as pembrolizumab, can cause immune-related adverse effects, including liver toxicity.19 Whether the concomitant use of CBD with these cancer treatments exacerbates potential liver function alterations remains unknown.
The US National Cancer Institute–led research initiative
To address knowledge gaps in how cancer patients access and use cannabis, their perceived risks and benefits with its use, and whether cancer survivors discuss cannabis use with their health-care providers during treatment, the National Cancer Institute (NCI) supported 12 NCI-designated comprehensive cancer centers to conduct surveys in 2019, which included standardized core questions on cannabis use during treatment, among their cancer patient populations.20 This P30 funding mechanism resulted in the publication of a JNCI Monograph, “Cannabis Use Among Cancer Survivors”.21 Importantly, these studies represented more than 13 000 patients across the United States and included states across the spectrum of cannabis legalization (eg, states where cannabis use was fully legal to states where cannabis is fully illegal including recreational use). Several key findings emerged from these P30-funded projects. Overall, 33% reported using cannabis (both before and since their cancer diagnosis) primarily via smoking, eating, or in oral forms such as tinctures.21 The 3 most common reasons for use were pain, mood, and sleep, and all patients (even those not using cannabis) indicated that the benefits outweighed the harms.21 Despite the high prevalence of use, only one-third of patients indicated that they spoke with a health-care provider about using cannabis.22 The P30 supplements generated an important knowledge base regarding cannabis use among patients with cancer and identified several important gaps including the lack of longitudinal data and information regarding potential harms.
In December 2020, the NCI convened a symposium titled Cannabis, Cannabinoids, and Cancer Research. The symposium identified critical research gaps such as understanding the extent and patterns of cannabis use by individuals with cancer, the perceived and real benefits and harms of use, potential associations with their cancer treatments and other medications, and the impact on comorbid conditions.23
The current initiative to understand longitudinal benefits and harms
In 2022, the NCI and the National Center for Complementary and Integrative Health issued a joint Request for Applications (RFACA-22 to 052) titled “Cannabis and Cannabinoid Use in Adult Cancer Patients During Treatment: Assessing Benefits and Harms.” The goal of this RFA was to fund well-designed prospective cohort studies of cancer patients to collaboratively address knowledge gaps and build evidence regarding the types of cannabis products used, frequency and dosage of use, and the associated benefits and harms during cancer treatment. In this RFA, cannabis was defined broadly to include any cannabis plant (eg, marijuana), cannabis-derived products or cannabinoids, tetrahydrocannabinol (THC), CBD-only products, prescription cannabinoids such as dronabinol and nabilone, and any other products made with or derived from cannabis. The RFA encouraged inclusion of patients with both solid and hematologic tumors and representation from heterogeneous populations by age, sex, tumor type, and geographic location. It also encouraged a broad range of data collection methods, including validated self-report instruments, electronic medical record (EMR) data, and if possible, biological data.
In response to the RFA, 5 studies were funded and are briefly described below. Table S1 provides project summaries: the setting and sites, a description of subjects and the survey contents, clinical data, and primary and secondary outcomes.
Multiple Principal Investigators: Ashare, Meghani, Nugent. This is a multisite, 12-month prospective cohort study of 450 patients with cancer treated with immune checkpoint inhibitors. Cannabis use, benefits, and harms will be assessed via ecological momentary assessment (collected for 7 consecutive days at each time point; 49 days total), patient-reported outcomes will be assessed via online/phone surveys, and routine clinical data will be extracted from EMRs. Among a subset of 60 patients who have not yet started immune checkpoint inhibitor treatment (30 cannabis users; 30 nonusers), immunological markers (eg, tumor necrosis factor-α, interleukin-6, C-reactive protein) will be examined at 4 time points. The specific aims are to (aim 1) assess benefits (pain severity and interference, sleep disturbance, anxiety, quality of life) and harms (difficulty concentrating, impaired memory, dizziness, fatigue) of cannabis use over time; (aim 2) test whether cannabis use over time moderates the associations between geographic characteristics and benefits and harms in aim 1; and (aim 3) among a subset of 60 patients with non-skin solid malignancies who have not yet started immune checkpoint inhibitor, explore the association of cannabis use with disease progression and immunological markers.
Multiple Principal Investigators: Cullen and Lee. The is a prospective cohort study of 700 patients with recently diagnosed multiple myeloma undergoing treatment to document the possible benefits and harms related to cannabis use compared with those not using cannabis. The study cohort will be drawn from 2 major cancer centers involving 10 locations over 5 states with heterogeneous patient populations. The primary aims are to (aim 1) document and describe longitudinal patterns in quality of life related to cannabis use as assessed by the Functional Assessment of Cancer Therapy-Multiple Myeloma, and (aim 2) document and describe the potential benefits and harms related to cannabis use as assessed by longitudinal patterns of patient-reported symptoms (Edmonton Symptoms Assessment Scale) and medical assessments (Common Terminology Criteria for Adverse Events). This study will also survey oncology health-care providers about their perceptions, education, and practice patterns regarding cannabis use by patients and estimate the prevalence of potential medication interactions related to cannabis use. An exploratory aim will be to explore the possible anti-inflammatory properties of cannabis use with cytokine profiling and correlations with symptoms and quality of life.
Multiple Principal Investigators: Hu and Wang. This study proposes a prospective cohort study of 600 breast cancer patients to address knowledge gaps and build evidence on the benefits and harms of medical cannabis and cannabinoid use during and after cancer treatment. Medical cannabis and cannabinoid use will be monitored through in-person visits and technology-based assessments such as smartphone and sensor-based measurement bursts. Blood samples will be collected to quantify and characterize medical cannabis and cannabinoid use and to analyze the inflammasome and inflammatory biomarkers. The study has 3 specifics aims: (aim 1) evaluate the benefits and harms of medical cannabis and cannabinoid use among breast cancer patients during and after treatment, (aim 2) determine whether inflammasome and inflammatory biomarkers mediate the benefits and harms of medical cannabis and cannabinoid use in breast cancer therapies and with other medications, and (aim 3) investigate how the characteristics of medical cannabis and cannabinoid products impact the benefits and harms (aim 1) and inflammasome and inflammatory biomarkers (aim 2).
Multiple Principal Investigators: Potosky and Haque. This is a prospective cohort study of 800 patients of a large, integrated community-based health-care system—Kaiser Permanente Southern California—to assess the effectiveness and safety of cannabis use over 12 months, with interim assessments occurring at 2, 4, and 6 months. The Kaiser Permanente Southern California cohort consists of patients newly diagnosed with colorectal, non-small cell lung cancer (NSCLC), or non-Hodgkin lymphoma and undergoing adjuvant systemic cancer therapy and those with metastatic breast, prostate, and gynecologic cancer undergoing palliative treatment. Survey data will be complemented with EMRs. To obtain more ecologically valid measures of cannabis use and patient-reported outcomes, investigators will also conduct brief (5-minute) daily assessments every 4 days in a subset of 400 patients up to 6 months postbaseline survey; half of the patients recruited will have reported cannabis use within the past 7 days. The daily assessments will also recruit patients who do not use cannabis, matched on cancer type and age as a comparator group. The study will compare patients who use cannabis to nonusers on 3 specific aims: (aim 1) assess the effects of cannabis use on patient-reported outcomes, focusing on pain, nausea, anxiety, depression, insomnia, appetite loss, and overall health-related quality of life (defined by physical, emotional, social functioning); (aim 2) determine whether and how cannabis use affects use of standard palliative therapies, such as reducing prescribed opioid use; and (aim 3) assess the negative effects associated with cannabis use (eg, injuries, falls and fractures, infections, cognition changes, changes in use of tobacco and alcohol, and cannabis use disorder). These outcomes will be assessed from follow-up surveys and EMR.
Multiple Principal Investigators: Reboussin, Romero-Sandoval, and Wagoner. This prospective cohort study conducted through the Wake Forest NCI Community Oncology Research Program Research Base (WF2304-A172401 COSMIC; NCT06418204) will examine the association between cannabis and cannabinoid use and cancer-related symptoms for a period of 1 year in 2000 adults recruited from the NCI Community Oncology Research Program clinics across the United States. Participants will be newly diagnosed breast, colorectal, melanoma, non-Hodgkin lymphoma, and NSCLC patients who are planning or recently started to receive 1 or more systemic cancer–directed therapies with chemotherapy and/or immune checkpoint inhibitors (targeting programmed death-1, programmed death-L1, or cytotoxic T-lymphocyte associate protein-4). The specific aims are as follows: (aim 1) describe the longitudinal patterns of cannabis use among adult cancer patients during treatment and the effect of individual-, clinical-, and community-level factors on these patterns; (aim 2) determine the potential benefits and harms of use on cancer and treatment-related symptoms (eg, nausea and vomiting, anxiety, neuropathy); and (aim 3) examine the impact of cannabis use on cancer treatment toxicity and in a subsample of NSCLC cancer patients planning to receive paclitaxel as part of their chemotherapy in conjunction with immune checkpoint inhibitors and examine potential drug interactions and impacts of cannabis use on inflammatory and immune response using biospecimens collected at cycles 1 and 3.
The development of core measures
The 5 grants were awarded fall of 2023, and a working group was formed consisting of representatives from each grant and NCI program officials to harmonize a core set of questions to assess cannabis use and patient-reported outcomes. The working group held regular virtual meetings to identify important cannabis-related topics and review existing surveys and literature. Several challenges quickly became evident. First, the variability in cannabis products poses a = challenge to measuring dose, quantity, and frequency of use. Ideally, we could assess quantity via a common measurement unit (eg, 5 mg THC). However, this requires that patients know the amount of THC in the products they use and can accurately report the quantity used. Whereas some formulations (eg, edibles) may facilitate this, other formulations, such as inhalables, vape oils, or smoked flower, are more difficult to measure quantity. Moreover, smoked flower is more likely to be obtained via sources other than state-licensed dispensaries (even when a patient lives in a state where dispensaries are accessible), and therefore the concentration of THC may be unknown.
The working group collaborated to finalize the core cannabis questionnaire, which assesses 9 modes of cannabis use. Because the measure was adapted for use in the current studies, NCI contracted with a research methods consulting agency to conduct cognitive testing of the survey. Cognitive testing is an exploratory qualitative method used to evaluate how survey respondents understand, interpret, and answer survey items.24 These cognitive interviews provided an opportunity to understand how patients might understand a question and to identify unanticipated problems. ICF research consultants conducted 17 patient interviews in June and July 2024 that covered 4 modes of cannabis use (eg, edibles, tinctures, smoke and vape dried herb, and vape liquids and oils). ICF generated a detailed report of their findings and recommendations for revising the survey. The working group and NCI program officials met with ICF to review and update several survey questions.
In addition to harmonizing measures of cannabis use, the working group identified several patient-reported outcome domains that will be assessed in all studies including pain, anxiety, sleep, depression, fatigue, physical function, and social function. Also, all studies will be assessing adverse effects (eg, via Patient-Reported Outcomes Measurement Information System, Brief Pain Inventory, NCI Patient-Reported Outcomes–Common Terminology Criteria for Adverse Events) and cannabis use disorder (via the Cannabis Use Disorder Identification Test), and some studies will also capture other adverse effects (eg, falls, fractures) from EMRs. Key cancer-related variables at baseline will also be assessed across all studies including cancer type, time since cancer diagnosis, stage at diagnosis (if applicable), and cancer treatment protocols (both local and systemic therapies).
Three studies are also incorporating ecological momentary assessment or daily assessment protocols, for either their full sample or a subset of patients. For example, Potosky and Haque will conduct brief (5-minute) assessments every 4 days in a subset (n = 400) of patients (200 who use cannabis and 200 nonexposed patients). Patients will complete 1 assessment per day every 4 days for 4–6 months via text messages and then weekly for 2 more months. The other 2 studies (Ashare, Meghani, and Nugent; Hu and Wang) will collect ecological momentary assessment data on all patients enrolled in their studies. Patients will complete 4 ecological momentary assessments per day (once in the morning and 3 delivered at random times throughout the day) for 7 days every month. Although the ecological momentary assessment designs are different with respect to frequency, method of assessment (eg, text-based vs smartphone app), and number and types of questions, representatives from each site identified opportunities to harmonize and share best practices. These discussions focused on strategies to improve compliance with completing the assessments (eg, patient remuneration).
Findings from patient populations
Importantly, the studies will be conducted across heterogeneous geographic locations and will recruit individuals with cancer from various health-care settings including NCI-designated cancer centers, integrated health-care systems, community oncology clinics and health plans, VA hospitals, and academic medical centers. As shown in Figure 1, this approach will yield a large and combined population of approximately 4350 patients, providing a representative picture of how patients with cancer use cannabis (along with comparison groups) than any single study could achieve. For instance, the collective data from these studies will facilitate evaluation of moderators of the effects of cannabis on patient-reported outcomes to identify which patients may benefit the most or be at highest risk from cannabis use. The geographic diversity of the clinical sites will also allow us to examine how regulatory environments impact cancer patients’ use of cannabis. The combined data will also permit evaluation of questions that no single study would be powered to test. For example, the combined sample will be large enough to compare patient-reported outcomes between various modes of cannabis use to determine patterns of use most likely to result in positive outcomes or increased toxicity risk (eg, ingested vs smoked cannabis). We will also be able to assess the impact of cannabis legalization on short-term cancer-related outcomes and analyze trajectories of cannabis use and associated outcomes over time, up to 12 months.
Figure 1.

Measurement and data harmonization process across studies.
Conclusion
The initiative led by the NCI represents a critical step forward in understanding the multifaceted role of cannabis use among cancer patients during treatment. By funding and coordinating 5 well-designed prospective cohort studies, this initiative leverages a collaborative and harmonized approach to reveal substantial knowledge gaps regarding the potential benefits and harms of cannabis and cannabinoid use. Together, these studies, encompassing a large number of cancer types, patient demographics, and treatment settings, aim to provide actionable insights into symptom management, quality of life, and the broader implications of cannabis use on health outcomes. The research underscores the importance of generating evidence-based guidelines to inform clinical practices and facilitate patient–provider discussions about cannabis use. The emphasis on harmonized data collection and advanced methodologies, such as ecological momentary assessment and biomarker analyses, will yield a comprehensive understanding of how cannabis impacts cancer care. Ultimately, the findings from this initiative have the potential to not only optimize symptom management but also mitigate risks associated with cannabis use in these disproportionately affected populations. This body of work lays the groundwork for future research, including randomized controlled trials, to refine our understanding and establish precise clinical recommendations and possibly inform public policy on medical cannabis use in some states. The NCI initiative exemplifies a forward-thinking approach to addressing a timely and complex issue in oncology care.
Supplementary Material
Supplementary material is available at JNCI: Journal of the National Cancer Institute online.
Implications.
We outline the research gaps and the objectives of the initiative and provide a summary of the 5 supported observational studies. This initiative promotes collaboration and data harmonization on core cannabis use and patient-reported outcomes across studies, providing insights to inform clinical guidelines for cannabis use in cancer patients and laying the groundwork for future randomized controlled clinical trials. Stakeholders, including researchers, clinicians, and public health officials, may benefit from the substantial evidence base generated by this initiative. An improved understanding of the impact of cannabis use on the health-related quality of life of patients with cancer is essential for optimizing symptom management and mitigating the potential adverse effects of cancer treatment. This evidence base may inform clinical guidelines about the potential optimal incorporation of cannabis as an important adjunct to conventional methods of symptom management for patients with cancer. In the meantime, this evidence will equip health-care providers to better inform individuals with cancer about benefits and harms of cannabis use.
Acknowledgments
The NCI and NCORP reviewed the final version of this manuscript but had no influence over the decision to submit for publication. This article was prepared as part of some of the authors’ (Andrew N. Freedman and Kelly K. Filipski) official duties as employees of the US Federal Government. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the National Cancer Institute.
Funding
This work was funded by grants from the National Cancer Institute at the National Institutes of Health (U01-CA286811, U01-CA286821, U01-CA286810, U01-CA286808, U01-CA286813). Drs. Reboussin, Romero-Sandoval, and Wagoner were also supported by the Wake Forest NCORP Research Base (UG1CA189824) and the Alliance NCORP Research Base (UG1CA189823).
Footnotes
Conflicts of interest
Drs Nugent, Ashare, Cullen, Haque, Hu, Lee, Meghani, Potosky, Reboussin, Romero-Sandoval, Wagoner, Wang, Worster, Filipski, Freedman report no conflicts of interest.
Data availability
No new data were generated or analyzed for this commentary.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
No new data were generated or analyzed for this commentary.
