Methylphenidate and Physical Activity in Reducing Cancer-Related Fatigue in Participants With Metastatic Melanoma Who Receive Anti-PD1 Immunotherapy



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:August 2, 2018
End Date:November 30, 2019
Contact:Sriram Yennu, MD
Email:syennu@mdanderson.org
Phone:713-745-1613

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A Study of Cancer Related Fatigue in Patients With Metastatic Melanoma Receiving Anti-PD1 Immunotherapy

Objectives:

1. 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 melanoma scheduled to receive anti-PD1 immunotherapy, as measured by changes in
Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F) subscale scores
after 2 weeks of intervention.

Hypothesis for Primary aim: We hypothesize that MP is capable of reducing CRF as measured by
the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F) in patients
with metastatic melanoma scheduled to receive anti-PD1 immunotherapy

Secondary Objective:

1.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.


Inclusion Criteria:

1. Part 1: have a diagnosis of metastatic melanoma and previously received anti-PD1
immunotherapy provided that they received therapy at least 1 month prior to enrollment

2. Part 1: be aged 18 years or older

3. Part 1: be willing to engage in follow-up telephone calls with a research staff

4. Part 1: have telephone access so they can be contacted by the research staff

5. Part 1: have a hemoglobin level of >/= 8 g/dL within 2 weeks of enrollment*

6. Part 1: be able to understand the description of the study and give written informed
consent

7. Part 1: able to read, write and speak English.

8. Part 2: presence of fatigue as defined FACIT-F subscale of [in which 52 = no fatigue and 0 =worst possible fatigue]

9. Part 2: not currently taking Methylphenidate, or have taken it within the previous 10
days;

10. Part 2: able to complete the baseline assessment forms

11. Part 2: able to understand the recommendations for participation in the study

Exclusion Criteria:

1. 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

2. 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

3. Part 2: on monoamine oxidase inhibitors, or clonidine

4. Part 2: history of glaucoma

5. Part 2: history of have severe cardiac disease (New York Heart Association functional
class III or IV)

6. Part 2: tachycardia and/or uncontrolled hypertension

7. Part 2: currently receiving anticoagulants, anticonvulsants (phenobarbital,
diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine,
clomipramine, or desipramine)

8. Part 2: patients with CAGE-AID >/=2
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Sriram Yennu
Phone: 713-745-2668
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mi
from
Houston, TX
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