PPP001 for Cancer Pain
This study is evaluating whether a new drug may help relieve pain for individuals with advanced cancer.
See full descriptionAbout the trial for Cancer Pain
Treatment Groups
This trial involves 2 different treatments. PPP001 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether PPP001 will improve 1 primary outcome and 5 secondary outcomes in patients with Cancer Pain. Measurement will happen over the course of Change from Baseline in distress thermometer at Week 4.
Patient Q & A Section
What are the signs of cancer pain?
Abnormal sensations such as itching and burning are typical manifestations of cancer pain. Abnormal sensations are more common in the late stages of cancer and rarely present early on. Many cases of cancer pain are not adequately controlled despite analgesia.
What are common treatments for cancer pain?
Common treatments for cancer pain include nonopiate and opiate-based medications. The use of opioids, benzodiazepines, and anxiolytics is common. There is a growing population of adolescents with cancer who endure chronic pain and require effective medication and supportive care.
What causes cancer pain?
The main reason was a strong pain impulse from the diagnosis and treatment, which is a consequence of the cancer and of the treatment. Pain was not related to the stage of the disease or to the type of treatment. Pain was caused by more or less common complications, mainly infection of the tumor or of the abdominal cavity. In most cases it is not really the cancer itself, rather its treatment: the chemotherapy or the radiotherapy, but also in many cases, by the surgical treatment, as in the amputation procedures or by the surgical damage to the blood-vessel supplying the tumor, especially the hepatic vessels.
How many people get cancer pain a year in the United States?
Nearly three million people in the United States have cancer pain a year. There are disparities by ethnicity and gender for breast and colorectal cancer pain.
What is cancer pain?
Cancer pain is a common symptom experienced by almost all cancer patients, and is typically more severe than other pain. It is a significant problem in all forms of cancer treatment, and can make cancer treatment more difficult. Furthermore, it is the single most important cause of pain-related functional impairment in cancer patients. There are a number of pain-causing mechanisms that we will discuss. These mechanisms are important for developing effective cancer pain management. More research is needed to identify and characterize the different types of pain patients have and their treatments.
Can cancer pain be cured?
With good management and treatment, about one half of cancer patients experience alleviating or complete elimination of cancer pain. However, with current management and treatment, many patients are still unable to control or eliminate their cancer pain, usually due to their noncompliance with the prescribed treatment regimen.
What are the latest developments in ppp001 for therapeutic use?
[There is evidence from several Phase I clinical trials supporting ppp001 as a therapeutic agent for cancer pain and that pharmacodynamics may be optimized by selecting patients with a history or clinical features of enhanced sensitivity in some clinical and/or laboratory features. Because the rationale for this work comes from a study in which dantrolene was already being used as a component of a new drug in cancer pain on clinical research protocols, the ppp001 agent is already a licensed drug for therapeutic use in a number of countries around the world.] The phase I studies will continue until the investigators are convinced that they have a therapeutic agent to add to their armamentarium.
What does ppp001 usually treat?
Ppp001 has been administered to adults and patients < 36 years of age at doses of up to 50 mg/kg/d by intrathecal injection. Clinicians have noted resolution of moderate to severe pain with the use of ppp001. This review indicates that ppp001 is frequently prescribed to pediatric patients. More importantly, it has a higher rate of toxicity when used in children than in adults. Further research has indicated that the use of ppp001 may result in a significant reduction in the use of opioids during pain management. The safety profile of ppp001 is not well established. Patients in need of ppp001 are often taking significant amounts of opioids by mouth to control pain.
What is the primary cause of cancer pain?
Pain attributable to cancer is mostly caused by metastases and/or pain-related malignancies (e.g., bone, kidney, thyroid, or lung carcinoma). A substantial number of patients present with more than one cause of cancer pain. Primary cancer pain can be effectively treated by treating the primary cancer and/or metastatic cause of pain. A number of pharmacological treatments can be used to treat cancer pain.
Does cancer pain run in families?
Despite the fact that previous studies have shown a genetic component to cancer pain, this preliminary study suggests that no single genetic locus, nor even allele, is responsible for hereditary cancer pain in our patient family. To our knowledge this is the first report to suggest a genetic (autosomal) etiology to cancer pain in a multigenerational family. A more detailed genetic study will be necessary and may reveal the genetic component of cancer pain in patients with hereditary cancer pain.
Is ppp001 typically used in combination with any other treatments?
As shown in this study, ppp001 is effective on its own to treat cancer-related pain but only when used alone or in combination with other drugs.
How does ppp001 work?
Overall the results have shown that the ppp001 has potential for treating patients with cancer pain who are not responsive to other painkillers. It has shown to reduce some common side-effects experienced with other medications for managing pain and also has the potential to reduce the need for anaesthesia- based medication, which can help to lower medical costs for this condition. However it seems that ppp001 is not yet effective enough to replace any one medical treatment.