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Multimodal Treatment Strategy for Cancer Cachexia

NCT00625742 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-02-12

Study results available
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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

Interventions

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.

DRUG

Atenolol

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.

DRUG

Ibuprofen

Ibuprofen 1200mg/day in three divided doses.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Rony Dev, DO · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00625742 on ClinicalTrials.gov