Multimodal Treatment Strategy for Cancer Cachexia

NCT00625742 | Terminated Results

• 2 other identifiers: 2006-0739NCI-2012-01744
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Advanced Cancer; Cachexia

Keywords

Advanced Cancer; Cancer Cachexia; Cachexia; Melatonin; Juven; Exercise Training; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Participant Gain in Lean Body Mass

  Measure increases in lean body mass in individuals with cancer who experience cachexia between baseline and day 29 (+/- 3 days).

  Baseline to Day 29, approximately 30 days

Secondary Outcomes (1)

• Improvement of Clinical Outcomes

  Baseline to Day 29, approximately 30 days

Study Arms (1)

Multimodal Treatment Strategy

EXPERIMENTAL

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.

Behavioral: Graded Resistance Training; Behavioral: Aerobic Exercise; Drug: Melatonin; Dietary Supplement: Juven; Drug: Atenolol; Drug: Ibuprofen

Interventions

Graded Resistance Training BEHAVIORAL

Resistance training sessions twice weekly using Thera-bands.

Multimodal Treatment Strategy

Aerobic Exercise BEHAVIORAL

Walking or running for 3-4 minutes at 70-80% of your maximum predicted heart rate.

Multimodal Treatment Strategy

Melatonin DRUG

20 mg by mouth (PO) Daily

Multimodal Treatment Strategy

Juven DIETARY_SUPPLEMENT

90 calories of Juven, twice a day.

Multimodal Treatment Strategy

Atenolol DRUG

Atenolol will only be taken if there's evidence of increased sympathetic activity (resting heart rate \>110 beats/min) or resting energy expenditure (REE) \> 110% of predicted.

Multimodal Treatment Strategy

Ibuprofen DRUG

Ibuprofen 1200mg/day in three divided doses.

Multimodal Treatment Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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® \[ramelteon\]).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Cachexia; Weight Loss

Interventions

Exercise; Melatonin; Atenolol; Ibuprofen

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Limitations and Caveats

The sample size of the available data is too small to detect any significant differences.

Results Point of Contact

• Title: Rony Dev, DO/Associate Professor, Palliative Care Med
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Rony Dev, DO

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 28, 2008
• Study Start: February 1, 2008
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 12, 2016
• Results First Posted: February 12, 2016

Record last verified: 2016-01

Locations

US (1)