Multimodal Treatment Strategy for Cancer Cachexia

This study has been terminated.
(Low Accrual)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00625742
First received: February 19, 2008
Last updated: June 16, 2014
Last verified: June 2014
  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 ]

Enrollment: 15
Study Start Date: February 2008
Primary Completion Date: June 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:

  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]).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, NCI-2012-01744
Study First Received: February 19, 2008
Last Updated: June 16, 2014
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
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014