Multimodal Treatment Strategy for Cancer Cachexia
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00625742
First received: February 19, 2008
Last updated: October 10, 2012
Last verified: October 2012
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Advanced Cancer Cachexia |
Behavioral: Graded Resistance Training Behavioral: Aerobic Exercise Drug: Melatonin Dietary Supplement: Juven |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Exploratory Trial of a Multimodal Treatment Strategy for Cancer Cachexia |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Participant Gain in Lean Body Mass [ Time Frame: Baseline, 15 days, and 29 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Multimodal Treatment Strategy
Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + 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.
|
Behavioral: Graded Resistance Training
Resistance training sessions twice weekly using Thera-bands.
Behavioral: Aerobic Exercise
Walking or running for 3-4 minutes at 70-80% of your maximum predicted heart rate.
Drug: Melatonin
20 mg by mouth (PO) Daily
Dietary Supplement: Juven
90 calories of Juven, twice a day.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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]).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625742
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Rony Dev, DO | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00625742 History of Changes |
| Other Study ID Numbers: | 2006-0739 |
| Study First Received: | February 19, 2008 |
| Last Updated: | October 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Advanced Cancer Cancer Cachexia Cachexia Melatonin |
Juven Exercise Training Weight Loss |
Additional relevant MeSH terms:
|
Cachexia Neoplasms Emaciation Weight Loss Body Weight Changes Body Weight Signs and Symptoms Melatonin |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013