Effect of Pentoxifylline treatment on quality of life and change in arm circumference compared to placebo in patients with cancer cachexia: A double-blind, randomized, placebo-controlled trial
This interventional study was design to assess the effect of Pentoxifylline treatment on quality of life and change in arm circumference compared to placebo in patients with cancer cachexia. 70 patients with advanced malignancy who have lost more than 5% of their ideal or body weight in the previous 2 months, will be enrolled. Patients with histologic or cytologic proof of cancer, and incurable malignancy with a life expectancy ≥ 4 months are eligible if they don’t have edema or ascites and adrenal corticosteroids treatment. Eligible patients will be randomly divided into two 35-member groups of intervention and control groups. Intervention group used Pentoxifylline (400 mg) three times a day, and controls will receive placebo three times a day. Treatment will be continued for a period of 2 months. Also patients will be unaware of the treatment allocation and will follow monthly by a doctor who is blinded to the study groups. Age, sex, weight change, change in arm circumference and quality of life are variables to be observed in this study. Change in arm circumference and quality of life as main outcome variables will be assessing at baseline, week-4 and week-8.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013081410297N2
Registration date:2013-11-23, 1392/09/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-23, 1392/09/02
Registrant information
Name
Leili Allahbakhshian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7079
Email address
allahbakhshian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-10-15, 1390/07/23
Expected recruitment end date
2012-06-15, 1391/03/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pentoxifylline treatment on quality of life and change in arm circumference compared to placebo in patients with cancer cachexia: A double-blind, randomized, placebo-controlled trial
Public title
Effect of Pentoxifylline treatment on quality of life and change in arm circumference compared to placebo in patients with cancer cachexia: A double-blind, randomized, placebo-controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are: 1. Histologic or cytologic proof evidencing cancers, 2. Incurable malignancy with a life expectancy≥4 months, 3. Weight loss perceived by the patient as a problem, 4. Patient should be alert and mentally competent. Exclusion criteria are: 1. Affliction with edema or ascites, 2. Adrenal corticosteroids treatment (except for dexamethasone during chemotherapy) androgens, progestational agents, or other appetite stimulants within the previous month, 3. Brain metastases, 4. Pregnancy or lactation, 5. Mechanical obstruction of the alimentary tract, 6. Malabsorption, or intractable vomiting, 7. Poorly controlled hypertension or congestive heart failure.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq