Clinical trial · Interventional
Open Labeled Placebo in Reducing Cancer Related Fatigue in Patients With Advanced Cancer
Open Labeled Placebo for Treatment of Cancer Related Fatigue in Patients With Advanced Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II/III trial studies an open labeled placebo to see how well it works compared with waitlist control in reducing cancer related fatigue in patients with cancer that has spread to other places in the body. A placebo is not a drug and is not designed to treat any disease or illness. Recent studies have found that cancer related fatigue symptoms in cancer survivors are improved with open labeled placebo (that is, patients know they are taking a placebo). It is not yet known how well an open labeled placebo works when compared with waitlist control in reducing cancer related fatigue.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Administration | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Waiting List | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (open labeled placebo)
- description
- Patients receive open labeled placebo PO BID for 4 weeks in the absence of disease progression.
- interventionNames
- Other: Placebo Administration
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Arm II (waiting list, open labeled placebo)
- description
- Patients are assigned to a waiting list during week 1. Beginning in week 2, patients receive open labeled placebo PO BID for 3 weeks in the absence of disease progression.
- interventionNames
- Other: Placebo Administration
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Other: Waiting List
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors) * Presence of fatigue of \>= 4/10 on Edmonton Symptom Assessment System (ESAS) Fatigue item (0-10 severity scale) * Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening * Uncontrolled pain; patient is on opioids for the treatment of cancer pain, he/she must have had no major dose change (\> 25%) for at least 48 hours prior to study entry. Change in opioid dose after study entry is allowed * Patient must be 18 years of age or older. The questionnaires used in this study have been validated only in the adult population * Patient must be willing to engage in telephone follow up with research staff * Patient must have telephone access to be contacted by the research staff * Hemoglobin level of \>= 8 g/dL. Patient may receive packed red blood cell (PRBC) transfusion so as to have hemoglobin level of \>= 8 g/dL so at participate in the study Exclusion Criteria: * Surgery, or pain relieving procedures within 2 weeks of entry into the study or during the study period * Patients with history of substance abuse (Cut down, Annoyed, Guilty, Eye opener \[CAGE\] \>= 2+), cognitively impaired (MD Anderson Symptom \[MDAS\] \> 7)
References
Publications (0)
Data not yet available