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NCT03525873
A Study of Cancer Related Fatigue in Patients With Metastatic Cancer Receiving Anti-PD1 Immunotherapy
Phase 3 trial testing Laboratory Biomarker Analysis in Advanced Malignant Neoplasm in 212 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2026
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 212 |
| Start date | 2 August 2018 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Laboratory Biomarker Analysis — full drug profile →
- Methylphenidate (methylphenidate) — full drug profile →
- Physical Activity
- Placebo
- Quality-of-Life Assessment
- Questionnaire Administration
Conditions studied
- Advanced Malignant Neoplasm — all drugs for Advanced Malignant Neoplasm →
- Metastatic Malignant Neoplasm — all drugs for Metastatic Malignant Neoplasm →
- Recurrent Malignant Neoplasm — all drugs for Recurrent Malignant Neoplasm →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Advanced Malignant Neoplasm or Metastatic Malignant Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Inflammation and tumor progression: signaling pathways and targeted intervention.
Zhao H, Wu L, Yan G, Chen Y, et al · · 2021 · cited 1932× · PMID 34248142 · DOI 10.1038/s41392-021-00658-5 -
Immunosenescence, Physical Exercise, and their Implications in Tumor Immunity and Immunotherapy.
Yu X, Pei W, Li B, Sun S, et al · · 2025 · cited 13× · PMID 39897036 · DOI 10.7150/ijbs.100948 -
Immunotherapy and fatigue: what we know and what we don't know.
Azeem Khan M, Florou V, Swami U. · · 2021 · cited 5× · PMID 33889294 · DOI 10.18632/oncotarget.27946
Verify or expand the search:
- PubMed search for NCT03525873
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03525873 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 15 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03525873.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing