Clinical trial · Interventional
Multimodal Treatment Strategy for Cancer Cachexia
An Exploratory Trial of a Multimodal Treatment Strategy for Cancer Cachexia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low Accrual
Summary
Brief summary (as posted)
The primary aim of this proposal is to present a novel, multimodal treatment strategy for increasing lean body mass in individuals with cancer who experience cachexia between baseline and day 29 (+/- 3 days). The strategy includes graded resistance training and aerobic exercise, targeted nutrient supplementation and pharmacologic intervention (melatonin). We postulate that this strategy, together with the simultaneous management of symptoms that decrease appetite (e.g. depression, pain, and nausea), will also accomplish our secondary objectives of improving clinical outcomes such as strength and function between baseline and day 29 (+/- 3 days).
Conditions
Conditions (2)
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 Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Cachexia | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aerobic Exercise | Behavioral | — | UNRESOLVED |
| Atenolol | Drug | — | UNRESOLVED |
| Graded Resistance Training | Behavioral | — | UNRESOLVED |
| Ibuprofen | Drug | Ibuprofen | ALIAS |
| Juven | Dietary Supplement | — | UNRESOLVED |
| Melatonin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multimodal Treatment Strategy
- description
- Exercise Program + Pharmacologic Intervention (Melatonin + Atenolol + Ibuprofen) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes at 70-80% of maximum predicted heart rate. Melatonin 20 mg by mouth (PO) Daily. 90 calories of Juven, twice a day.
- interventionNames
- Behavioral: Graded Resistance Training
- Behavioral: Aerobic Exercise
- Drug: Melatonin
- Dietary Supplement: Juven
- Drug: Atenolol
- Drug: Ibuprofen
Primary outcomes (1)
- measure
- Participant Gain in Lean Body Mass
- timeFrame
- Baseline to Day 29, approximately 30 days
- description
- Measure increases in lean body mass in individuals with cancer who experience cachexia between baseline and day 29 (+/- 3 days).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Are referred to the Cachexia Clinic with involuntary weight loss of \>5% of their premorbid weight within the previous 6 months. 2. Are 18 years of age or older 3. Have a Karnofsky performance score of 60 or higher. 4. Can maintain oral food intake during the study 5. Can understand the study procedures and can sign an informed consent form. 6. Are not currently taking melatonin. 7. Are taking megestrol acetate and continue to lose weight despite at least 2 weeks of therapy. 8. Have a calculated creatinine clearance of \>/= 60 cc/min. Exclusion Criteria: 1. Have dementia or delirium (as determined by the palliative care specialist) at study entry. 2. Are pregnant 3. Have been taking corticosteroids for longer than 48 hours. 4. Have pulmonary edema, ascites or pitting edema on clinical examination. 5. Are unable to walk. 6. Have a history of serious adverse gastrointestinal events (i.e., bleeding or perforation),history of a coagulopathy or current anti-coagulant use. 7. Have an ALT/AST\>3x upper limit of normal. 8. Patients on methotrexate. 9. Patients taking melatonin receptor agonists (such as Rozerem® \[ramelteon\]).
References
Publications (0)
Data not yet available