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

NCT03525873 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2017-0913NCI-2018-00698
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Malignant Neoplasm; Metastatic Malignant Neoplasm; Recurrent Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Assessment of the effects of methylphenidate (MP) plus physical activity in reducing cancer-related fatigue (CRF)

  Effects of MP to be compared to placebo plus physical activity results. To be as measured by changes in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) sub-scale scores. A t test will be used to evaluate the difference between groups unless the data appear to be non-normally distributed, in which case a Wilcoxon rank-sum test will be used to evaluate the difference between groups.

  Up to 12 weeks

Secondary Outcomes (6)

• Assessment of MP effects on physical activity

  Up to 12 weeks

• Assessment of MP effects on anxiety, depressed mood, and cancer symptoms by questionnaires

  Up to 5 minutes during visit

• Assessment of MP effects on anxiety, depressed mood, and cancer symptoms by questionnaires

  Up to 5 minutes during visit

• Assessment of MP effects on anxiety, depressed mood, and cancer symptoms by questionnaires

  Up to 5 minutes during visit

• Assessment of MP effects on anxiety, depressed mood, and cancer symptoms by questionnaires

  Up to 5 minutes during visit

Other Outcomes (1)

• Assessment of MP effects on levels of serum IL-1b, IL-1 RA, IL-6, TNF-a, IL-8,IL-10, and MCP1

  At weeks 2, 6, and 10

Study Arms (2)

ARM I (methylphenidate, physical activity)

EXPERIMENTAL

Patients receive methylphenidate PO 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 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.

Other: Laboratory Biomarker Analysis; Drug: Methylphenidate; Other: Physical Activity; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

ARM II (placebo, physical activity)

PLACEBO COMPARATOR

Patients receive a matched placebo PO BID and complete physical activity as in Arm I. Treatment continues for up to 2 weeks in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Other: Physical Activity; Other: Placebo; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

ARM I (methylphenidate, physical activity); ARM II (placebo, physical activity)

Methylphenidate DRUG

Given PO

Also known as: Daytrana

ARM I (methylphenidate, physical activity)

Physical Activity OTHER

Participate in physical activity

ARM I (methylphenidate, physical activity); ARM II (placebo, physical activity)

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

ARM II (placebo, physical activity)

Questionnaire Administration OTHER

Ancillary studies

ARM I (methylphenidate, physical activity); ARM II (placebo, physical activity)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

ARM I (methylphenidate, physical activity); ARM II (placebo, physical activity)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasm Metastasis; Recurrence

Interventions

Methylphenidate; Exercise

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sriram Yennu

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 16, 2018
• Study Start: August 2, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)