Methylphenidate and Physical Activity to Reduce Cancer Related Fatigue Due to Anti PD1 Immunotherapy

This is an interventional treatment trial for Advanced Malignant Neoplasm Read More

Inclusion Criteria:

• Part 1: have a diagnosis of metastatic or recurrent cancer and previously received anti PD1 immunotherapy provided that they received therapy up to 1 month prior to enrollment
• Part 1: be willing to engage in follow-up telephone calls with a research staff
• Part 1: have telephone access so they can be contacted by the research staff

• Part 1: hemoglobin level of >= 8 g/dL within 2 weeks of enrollment

  * Packed red blood cell (PRBC) transfusions will be allowed to patients with hemoglobin < 8 g/dl

• Part 1: be able to understand the description of the study and give written informed consent
• Part 1: able to read, write and speak English
• Part 2: have a diagnosis of metastatic or recurrent cancer and previously received anti PD1 immunotherapy provided that they received therapy up to 1 month prior to enrollment
• Part 2: be willing to engage in follow-up telephone calls with a research staff
• Part 2: have telephone access so they can be contacted by the research staff

• Part 2: have a hemoglobin level of >=8 g/dL within 2 weeks of enrollment

  * PRBC transfusions will be allowed to patients with hemoglobin < 8 g/dl

• Part 2: be able to understand the description of the study and give written or verbal informed consent
• Part 2: able to read, write and speak English
• Part 2: presence of fatigue as defined FACIT-F subscale of =< 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 = worst possible fatigue)
• Part 2: not currently taking methylphenidate, or have taken it within the previous 10 days
• Part 2: able to complete the baseline assessment forms
• Part 2: able to understand the recommendations for participation in the study
• Part 2: can be enrolled directly to part 2 independent of part 1 if on immunotherapy and having a FACIT-F fatigue =< 34, and able to complete baseline assessment and bloodwork as detailed in Part 1 at baseline and day 14 +/-3 days. Treating Oncologist should agree for participation in the intervention trial

Exclusion Criteria:

• Part 1: patients will be excluded if (1) have clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of >= 13 at baseline completed in person, by phone, or via video-conference
• Part 2: Patients will be excluded if (1) have clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of >= 13 at baseline completed in person, by phone, or via video-conference
• Part 2: have a major contraindication to MP (e.g., allergy/hypersensitivity to study medications or their constituents), or conditions making adherence difficult as determined by the attending physician
• Part 2: on monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine
• Part 2: history of glaucoma
• Part 2: history of have severe cardiac disease (New York Heart Association functional class III or IV)
• Part 2: tachycardia and/or uncontrolled hypertension
• Part 2: currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine)
• Part 2: patients with Cut Down, Annoyed, Guilty and Eye Opener-Adapted to Include Drugs (CAGE-AID) >= 2