CLINICAL TRIAL

PPP001 for Cancer Pain

Locally Advanced
Recruiting · 18+ · All Sexes · Cave Creek, AZ

This study is evaluating whether a new drug may help relieve pain for individuals with advanced cancer.

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About the trial for Cancer Pain

Eligible Conditions
Cancer Pain · Acute Pain · Marijuana Abuse · Quality of Life (QOL) · Pain, Acute · Cannabis Use

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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
PPP001
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PPP001
2018
Completed Phase 1
~60

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Advanced cancer for which there is no known curative therapy as per investigator's judgement
If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose, If of non-childbearing potential - should be surgically sterile or in a menopausal state
Written informed consent
Adult male and female patients at least 18 years of age
Subject agreed to follow the protocol
Patients experiencing at least 2 symptoms related to cancer > 4 on ESAS-r-CS NRS including pain symptom
Life expectancy six weeks or longer with PPS > 50% and PaP Score Group A (30-day survival probability >70%)
No cognitive impairment according to Mini-Cog©
The patient is able to perform deep inhalations with FEV1 more than 60%
Ability to read and respond to questions in English
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: change from baseline in the EORTC-QLQ-C15-PAL pain multi-item scale score at Week 4.
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline in the EORTC-QLQ-C15-PAL pain multi-item scale score at Week 4.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: change from baseline in the EORTC-QLQ-C15-PAL pain multi-item scale score at Week 4..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

The distress of patients with advanced cancer will be measured using a patient self-administered questionnaire
CHANGE FROM BASELINE IN DISTRESS THERMOMETER AT WEEK 4
distress thermometer adopted as a screening measure to identify and address psychological distress in individuals with cancer. Results support a cut-off score of 3 on the DT to indicate patients with clinically elevated levels of distress .
CHANGE FROM BASELINE IN DISTRESS THERMOMETER AT WEEK 4
The satisfaction of family caregivers of patients with advanced cancer will be measured using a caregiver self administered questionnaire.
CHANGE FROM BASELINE IN TREATMENT-SATISFACTION QUESTIONNAIRE AT WEEKS 1 AND 4
The treatment satisfaction questionnaire (change version) will be used. Scale range is a left to right 7-item scale for caregiver. each item is scored from 5 (Much more satisfied now) to 1 (Much Less satisfied now).
CHANGE FROM BASELINE IN TREATMENT-SATISFACTION QUESTIONNAIRE AT WEEKS 1 AND 4
The physical, emotional, and total symptom distress will be measured using a patient self administered questionnaire.
CHANGE FROM BASELINE IN ESAS-R-CS AT WEEKS 1 AND 4
Revised Edmonton Symptom Assessment System (ESAS-r-CS). 11 core symptoms: pain, tiredness, nausea, depression, anxious, drowsiness, appetite, feeling of well-being, shortness of breath, constipation and trouble sleeping. 11-point NRS ranging from 0 (no symptom) to 10 (worst possible).
CHANGE FROM BASELINE IN ESAS-R-CS AT WEEKS 1 AND 4
The palliative performance scale will be scored by a healthcare profesional.
CHANGE FROM BASELINE IN PPS AT WEEKS 1 AND 4
palliative performance scale version 2 (PPSv2) for measuring functional status in end-of-life patients. A healthcare professional scores each dimension by assigning a value from 100% to 0% (death), with 10% denoting the lowest level of functioning
CHANGE FROM BASELINE IN PPS AT WEEKS 1 AND 4
The overall HRQoL (Health related Quality of Life) of patients with uncontrolled symptoms related to advanced cancer will be measured using a patient self rating questionnaire.
CHANGE FROM BASELINE IN THE EORTC-QLQ-C15-PAL OVERALL QOL SINGLE-ITEM SCALE SCORE AT WEEK 4
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL). single-item scale is rated from 1 (very poor) to 7 (excellent). High scores on a functional scale correspond to better functioning
CHANGE FROM BASELINE IN THE EORTC-QLQ-C15-PAL OVERALL QOL SINGLE-ITEM SCALE SCORE AT WEEK 4
Uncontrolled cancer pain will be measured using a patient self-administered questionnaire.
CHANGE FROM BASELINE IN THE EORTC-QLQ-C15-PAL PAIN MULTI-ITEM SCALE SCORE AT WEEK 4.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL). items are rated on a scale of 1 (not at all) to 4 (very much). high scores on a symptom scale correlate to increased symptom burden
CHANGE FROM BASELINE IN THE EORTC-QLQ-C15-PAL PAIN MULTI-ITEM SCALE SCORE AT WEEK 4.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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