Advanced Malignant Neoplasm Clinical Trial
Official title:
A Study of Cancer Related Fatigue in Patients With Metastatic Cancer Receiving Anti-PD1 Immunotherapy
This phase III trial studies how well methylphenidate and physical activity works in reducing cancer-related fatigue in patients who are receiving anti-PD1 immunotherapy for cancer that has spread to other places in the body. Central nervous systems stimulants, such as methylphenidate, may help to improve cognitive function. Physical activity uses techniques, such as aerobic and resistance exercises, which may help to improve quality of life. Giving methylphenidate and physical activity may help in reducing cancer-related fatigue in patients with metastatic cancer who receive anti-PD1 immunotherapy.
PRIMARY OBJECTIVES: I. To determine the effects of methylphenidate plus physical activity (MP) compared to placebo plus physical activity (PL) in reducing cancer-related fatigue (CRF) in patients with metastatic cancer on anti-PD1 immunotherapy, as measured by changes in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale scores after 2 weeks of intervention. SECONDARY OBJECTIVES: I. To explore the effect of MP on anxiety (Hospital Anxiety and Depression Scale [HADS]), depressed mood (HADS), cancer symptoms (Edmonton Symptom Assessment Scale (ESAS), physical activity (mean day time activity as measured by actigraphy), and serum levels of inflammatory cytokines (IL-1beta, IL-1 RA, IL-6, TNF-alpha, IL-8, IL-10, and MCP1), before and after treatment. EXPLORATORY OBJECTIVES: I. To determine the frequency and factors associated with CRF as assessed by FACIT-F, Patient-Reported Outcomes Measurement Information System Fatigue (PROMIS-F), Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), actigraphy, Edmonton Symptom Assessment System (ESAS), and serum levels of inflammatory cytokines (IL-1beta, IL-1 RA, IL-6, TNF-alpha, IL-10, IL-8, MCP-1), before and during 4 initial doses of Immunotherapy. II. To explore the effects of MP on percentage (%) of patients with dose reduction and/or discontinuation anti-PD1 immunotherapy due to CRF. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive methylphenidate orally (PO) twice daily (BID) for up to 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete physical activity consisting of walking and resistance exercise over 25-40 minutes once daily (QD) 4 days a week. After 2 weeks, patients may continue methylphenidate at the discretion of the treating physician for up to 12 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive a matched placebo PO BID and complete physical activity as in Arm I. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03671226 -
Preference of Room Setting and Waiting Time in Patients With Advanced, Locally Advanced, or Metastatic Cancer and Their Caregivers Who Are Seen in the Outpatient Supportive/Palliative Care Center
|
N/A | |
| Recruiting |
NCT05048160 -
A Clinical Study of 6MW3211 Injection in the Treatment of Advanced Malignant Neoplasm
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03287492 -
RCT of QPS vs General Information Sheet
|
N/A | |
| Recruiting |
NCT01549067 -
The Real Clinical Background of Advanced Colorectal Cancer Treatment Situation Survey
|
N/A | |
| Recruiting |
NCT04119037 -
Cordotomy in Reducing Pain in Patients With Advanced Cancer
|
N/A | |
| Recruiting |
NCT04067336 -
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04585750 -
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
|
Phase 1/Phase 2 | |
| Completed |
NCT02823652 -
Pre-Test Genetic Education and Remote Genetic Counseling in Communicating Tumor Profiling Results to Patients With Advanced Cancer
|
N/A | |
| Completed |
NCT00244972 -
Tipifarnib and Sorafenib Tosylate in Treating Patients With Biopsiable Advanced Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT01582191 -
Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT03856060 -
Videos and Questionnaires in Assessing Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During Clinic Visits
|
N/A | |
| Completed |
NCT04186884 -
Caregiver Burden, Quality of Life, and Symptom Distress at Different Palliative Cancer Care Settings
|
||
| Completed |
NCT02583269 -
Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery
|
Phase 1 | |
| Withdrawn |
NCT03868423 -
Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers
|
Phase 2 | |
| Terminated |
NCT02940223 -
Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01552434 -
Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease
|
Phase 1 | |
| Active, not recruiting |
NCT03021486 -
Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03203525 -
Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT01624766 -
Everolimus and Anakinra or Denosumab in Treating Participants With Relapsed or Refractory Advanced Cancers
|
Phase 1 | |
| Recruiting |
NCT05985278 -
Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy
|
Early Phase 1 |