An Exploratory Trial of a Multimodal Treatment Strategy for Cancer Cachexia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Participant Gain in Lean Body Mass
Study Overview
Brief Summary
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).
Detailed Description
The Study Drugs:
Melatonin is a hormone that helps reduce inflammation and poor food absorption caused by cancer. It may also enhance the effects of ibuprofen.
Juven is a nutritional supplement that is designed to help build muscle and slow muscle breakdown.
Screening Tests:
Before you can start treatment on this study, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests will be performed:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Are referred to the Cachexia Clinic with involuntary weight loss of >5% of their premorbid weight within the previous 6 months.
- •Are 18 years of age or older
- •Have a Karnofsky performance score of 60 or higher.
- •Can maintain oral food intake during the study
- •Can understand the study procedures and can sign an informed consent form.
- •Are not currently taking melatonin.
- •Are taking megestrol acetate and continue to lose weight despite at least 2 weeks of therapy.
- •Have a calculated creatinine clearance of >/= 60 cc/min.
Exclusion Criteria
- •Have dementia or delirium (as determined by the palliative care specialist) at study entry.
- •Are pregnant
- •Have been taking corticosteroids for longer than 48 hours.
- •Have pulmonary edema, ascites or pitting edema on clinical examination.
- •Are unable to walk.
- •Have a history of serious adverse gastrointestinal events (i.e., bleeding or perforation),history of a coagulopathy or current anti-coagulant use.
- •Have an ALT/AST>3x upper limit of normal.
- •Patients on methotrexate.
- •Patients taking melatonin receptor agonists (such as Rozerem® [ramelteon]).
Arms & Interventions
Multimodal Treatment Strategy
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.
Intervention: Graded Resistance Training (Behavioral)
Multimodal Treatment Strategy
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.
Intervention: Aerobic Exercise (Behavioral)
Multimodal Treatment Strategy
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.
Intervention: Melatonin (Drug)
Multimodal Treatment Strategy
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.
Intervention: Juven (Dietary Supplement)
Multimodal Treatment Strategy
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.
Intervention: Atenolol (Drug)
Multimodal Treatment Strategy
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.
Intervention: Ibuprofen (Drug)
Outcomes
Primary Outcomes
Participant Gain in Lean Body Mass
Time Frame: Baseline to Day 29, approximately 30 days
Measure increases in lean body mass in individuals with cancer who experience cachexia between baseline and day 29 (+/- 3 days).
Secondary Outcomes
- Improvement of Clinical Outcomes(Baseline to Day 29, approximately 30 days)