Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2015
A phase 3 trial of armodafinil for the treatment of cancer-related fatigue for patients with multiple myeloma.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 7 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 7 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Management of Fatigue in Adult Survivors of Cancer: ASCO-Society for Integrative Oncology Guideline Update.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Guideline
- Placebo response in trials of drug treatments for cancer-related fatigue: a systematic review, meta-analysis and meta-regression.BMJ supportive & palliative care · 2020Pooled it
- The efficacy of placebo for the treatment of cancer-related fatigue: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020Pooled it
- Psychostimulants for cancer-related cognitive impairment in adult cancer survivors: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019Pooled it
- Psychostimulants for cancer-related cognitive impairment in adult cancer survivors: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019Pooled it
- Pharmacologic interventions for fatigue in cancer and transplantation: a meta-analysis.Current oncology (Toronto, Ont.) · 2018Pooled it
- Pharmacological Interventions for the Management of Cancer-Related Fatigue Among Cancer Survivors: Systematic Review and Meta-Analysis.Integrative cancer therapiesPooled it
- Effects of cognitive behavioral therapy for insomnia and armodafinil on quality of life in cancer survivors: a randomized placebo-controlled trial.Journal of cancer survivorship : research and practice · 2017Trial
- Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: a randomized placebo-controlled trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016Trial
- Effects of armodafinil and cognitive behavior therapy for insomnia on sleep continuity and daytime sleepiness in cancer survivors.Sleep medicine · 2016Trial
- Top Ten Tips Palliative Care Clinicians Should Know About Diagnosing, Categorizing, and Addressing Fatigue.Journal of palliative medicine · 2025Article
- Review
- Review
- A Molecular Approach to Understanding the Role of Diet in Cancer-Related Fatigue: Challenges and Future Opportunities.Nutrients · 2022Review
- Cognitive adverse effects of chemotherapy and immunotherapy: are interventions within reach?Nature reviews. Neurology · 2022Review
- Effects of Endocrine Therapy on Cognitive Function in Patients with Breast Cancer: A Comprehensive Review.Cancers · 2022Review
- A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures.Contemporary clinical trials · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeFatigue is a common problem among multiple myeloma (MM) patients. Armodafinil is a drug known to promote wakefulness, which is related to modafinil, a compound that improves fatigue in some cancer patients treated with chemotherapeutic agents. We investigated whether armodafinil could reduce cancer-related fatigue in MM patients.
methodsThis double-blind, placebo-controlled phase 3 trial evaluated the efficacy of armodafinil in MM patients with evidence of moderate fatigue. Patients were randomized to one of two arms: treatment-only, with armodafinil given at 150 mg/daily for 56 days, or placebo-first, with placebo given on days 1-28, followed by armodafinil administered at 150 mg daily on days 29-56. Fatigue was measured on days 1 (pre-dose: baseline), 15, 28, 43, and 56 using seven separate assessments, including four patient-reported outcomes of fatigue and related quality of life measures, as well as three objective measures of cognitive function.
resultsOverall toxicities were similar between treatment groups. No significant differences were observed between the placebo-first and the treatment-only arms after 28 days. Treatment with armodafinil for 28 additional days did not produce responses. Both placebo-first and treatment-only patients showed similar significant improvements in three patient-reported measures and one objective task at day 28 compared to baseline. Placebo-first patients improved on eight additional measures (one patient-reported measure, six subscales, and one objective task), suggesting a strong placebo effect in this patient population.
conclusionsEvaluation and treatment of cancer-related fatigue continues to be challenging; a clear definition of this symptom and better assessment tools are needed.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.