Pain is one of the most burdensome and feared symptoms among cancer patients. Opioids are often used to treat acute pain during cancer treatment, yet this exposure to opioids presents a strong risk factor for cancer patients to become long-term opioid users. All clinical practice guidelines recommend a combination of drugs and non-drug therapy for treatment of acute pain. Currently, it is unclear how best to combine these two approaches (drug and non-drug) to achieve what patients desire. Our research study will produce scientific evidence to guide patients and clinicians in how to optimize pain management during cancer treatment. We led a previous study showing that acupuncture, a non-drug pain treatment, may control pain in patients who receive high-dose chemotherapy and bone marrow transplants, while lessening the use of opioid pain medications and some of the side effects that opioids produce; we now propose a larger study in 300 patients to confirm these previous findings. We hope the data will show that if we use acupuncture first to prevent pain—and add opioids only if the pain is not well controlled—we may manage patients’ pain better than if we relied only on opioids.
This research will produce scientific evidence that will help guide clinical practice. High-dose chemotherapy treatment can cause patients to experience severe pain from inflammation in the mouth. This inflammation can lead to malnutrition, dehydration, weight loss, depression, and lower quality of life. Patients who use opioids for this acute pain often develop side effects such as constipation, nausea, poor appetite, and drowsiness. These patients are also more likely to become chronic opioids users after they complete their cancer treatment. Our research study aims to replicate the effectiveness of acupuncture from our previous study.
When we designed this study, we created a patient/stakeholder advisory committee to offer views on the following questions:
- What clinical problems are the most important to patients receiving high-dose chemotherapy?
- How should we select patients for the study?
- What should we measure during the study?
- How should we engage patients so that more of them will participate and complete the study?
- What are the best ways to make the study results known to the cancer clinician and patient communities so that as many people as possible can benefit?
We included committee members’ viewpoints in the design of the study to make it truly patient centered. After the study begins, this committee will meet twice a year so that members can continue to share their ideas and views, trouble-shoot, and make other contributions to ensure that the study is successful.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.