Cachexia, Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief summary
Pulmonary cachexia, observed in individuals with chronic obstructive pulmonary disease (COPD) is a multifactorial syndrome characterized by disruptions in energy metabolism, increased protein degradation, and an impaired capacity to preserve muscle mass. These metabolic disturbances not only exacerbate the underlying respiratory condition but also significantly contribute to elevated mortality rates among affected individuals. Current therapeutic strategies for managing cachexia primarily emphasize pharmacological treatments, nutritional interventions, and multimodal approaches. Among the nutritional interventions, various supplements have shown potential in mitigating the catabolic processes associated with cachexia. Notably, supplementation with n-3 polyunsaturated fatty acids (n-3 PUFAs) and vitamin D has emerged as a promising intervention, likely due to their involvement in key pathological mechanisms underlying the disease. While previous studies have investigated the combined effects of these supplements through oral nutritional supplementation, this study aims to evaluate and compare the clinical effectiveness of n-3 PUFAs and vitamin D as distinct therapeutic interventions for managing pulmonary cachexia.
Interventions
DIETARY_SUPPLEMENTN-3 Polyunsaturated Fatty Acids (PUFA)
Dosage, 1000 mg per dose; Frequency, Twice daily (BID); Duration, Six weeks; Administration Route, Oral softgel capsule; Manufacturer, Donated by NOW Foods (Bloomingdale, Illinois, USA).
DIETARY_SUPPLEMENTVitamin D
Dosage, 1000 IU per dose (total 2000 IU per day); Frequency, Twice daily (BID); Duration, Six weeks; Administration Route, Oral softgel capsule; Manufacturer, Donated by NOW Foods (Bloomingdale, Illinois, USA).
Sponsors
Safeer Khan
University of Lahore
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Able to provide both written and verbal consent. 2. Clinically diagnosed with chronic obstructive pulmonary disease (COPD). 3. Diagnosis of pulmonary cachexia according to Cachexia Consensus Conference criteria
Exclusion criteria
1. Patients experiencing acute exacerbations of COPD. 2. Patients with co-morbid chronic diseases that can also cause cachexia, including cancer, HIV/AIDS, heart failure, chronic renal failure, liver cirrhosis, and rheumatoid arthritis 3. Pregnant women and patients with abnormal liver and/or renal function tests. 4. Patients who have taken n-3 PUFAs, Vitamin D, or any intervention for cachexia in the past four weeks. 5. Patients on oral or parenteral corticosteroids for more than four weeks. 6. Patients with a history of allergies to fish-derived products, n-3 polyunsaturated fatty acids (PUFAs), or Vitamin D. 7. Patients with a metabolic disorder that can lead to changes in body composition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | Baseline and Week 6 | Change in BMI from baseline (pre-intervention), measured using a calibrated weight and height scale, and expressed in kg/m². |
| Fat-Free Mass Index (FFMI) | Baseline and week 6 | Change in FFMI from baseline (pre-intervention), measured using bioelectrical impedance analysis, and expressed in kg/m². |
| Fat Mass Index (FMI) | Baseline and week 6 | Change in FFM from baseline (pre-intervention), measured using bioelectrical impedance analysis, and expressed in kg/m². |
| Handgrip Strength (HGS) | Baseline and week 6 | Change from baseline HGS measured in kilograms using a calibrated dynamometer. |
| Mid-Arm Muscle Circumference (MAMC) | Baseline and week 6 | Change in MAMC from baseline (pre-intervention), calculated using the formula: MAMC = Mid-Arm Circumference (MAC) - (π × Triceps Skinfold (TSF)), expressed in centimeters (cm). The Mid-Arm Circumference (MAC) is measured using a flexible tape measure at the midpoint of the upper arm, and Triceps Skinfold (TSF) is measured using skinfold caliper. |
| Simplified Nutritional Appetite Questionnaire (SNAQ) - Anorexia | Baseline and week 6 | Change in SNAQ score from baseline (pre-intervention). SNAQ is a brief, four-item screening tool used to assess anorexia with a score of 14 or below indicates poor appetite. |
| Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) | Baseline and week 6 | Change in FACIT-F score from baseline (pre-intervention). FACIT-F is a 13-item scale used to assess the severity of fatigue in patients with chronic illnesses, with a scale range of 0 to 52. Higher scores indicate less fatigue (better functional status), while lower scores indicate more severe fatigue (worse functional status). |
| Edmonton Symptom Assessment System (ESAS) - Symptom Burden | Baseline and week 6 | Change in ESAS score from baseline (pre-intervention). ESAS is a multi-item scale used to assess symptom burden in patients. The scale ranges from 0 to 100, with higher scores indicating greater symptom severity and lower scores indicating less severe symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | Week 6 | Percentage of patients achieving medication adherence of 80% or more, as assessed through pill count. |
| Adverse Effects | Eight weeks | Percentage of patients experiencing adverse effects, assessed throughout the study. |
Countries
Pakistan
Outcome results
None listed