Trial Outcomes & Findings for A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia (NCT NCT00815685)
NCT ID: NCT00815685
Last Updated: 2017-03-23
Results Overview
Change in protein status at 6 weeks after initial diagnosis of weight loss of \>5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
6 weeks per patient
Results posted on
2017-03-23
Participant Flow
Eligible participants will include cancer patients with Men and Women \>25 years of age (inclusive), with a confirmed diagnosis of cancer, unintentional weight loss of \>5% of body weight, using uniform established diagnostic criteria and be admitted to the study within 3 month of diagnosis.
Participant milestones
| Measure |
Eicosapentaenoic Acid (Lovaza)
Participants to receive Lovaza at a dose of 4 g for 6 weeks.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia
Baseline characteristics by cohort
| Measure |
Eicosapentaenoic Acid (Lovaza)
n=36 Participants
Participants to receive Lovaza at a dose of 4 g for 6 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 weeks per patientChange in protein status at 6 weeks after initial diagnosis of weight loss of \>5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers.
Outcome measures
| Measure |
Eicosapentaenoic Acid (Lovaza)
n=14 Participants
Participants to receive Lovaza at a dose of 4 g for 6 weeks.
|
|---|---|
|
Change in Serum Albumin
|
4.0 g/dL
Interval 3.1 to 4.7
|
SECONDARY outcome
Timeframe: 6 weeks per patientPopulation: Participants with available pre and post-treatment serum samples.
There is no expected range for "normal" activity since there is not currently a clinical indication for these molecular markers. Comparison of ranges can be made between groups (such as those that received treatment and not). This was an exploration of potential in the pilot study and further research is indicated to better understand the metabolic abnormalities observed in cancer cachexia as well as potential benefits of using agents such as EPA.
Outcome measures
| Measure |
Eicosapentaenoic Acid (Lovaza)
n=14 Participants
Participants to receive Lovaza at a dose of 4 g for 6 weeks.
|
|---|---|
|
Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%.
|
9 Participants
|
Adverse Events
Eicosapentaenoic Acid (Lovaza)
Serious events: 4 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eicosapentaenoic Acid (Lovaza)
n=36 participants at risk
Participants to receive Lovaza at a dose of 4 g for 6 weeks.
|
|---|---|
|
Vascular disorders
CNS
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Gastrointestinal disorders
Dehydration
|
5.6%
2/36 • Number of events 2 • 6 weeks per participant
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
2/36 • Number of events 2 • 6 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Febrile Neutropenia
|
5.6%
2/36 • Number of events 2 • 6 weeks per participant
|
|
Metabolism and nutrition disorders
Glucose serum-high
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Cardiac disorders
Hypotension
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Gastrointestinal disorders
Mucositis/stomach - Oral cavity
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Gastrointestinal disorders
Nausea
|
5.6%
2/36 • Number of events 2 • 6 weeks per participant
|
|
General disorders
Pain - Chest/Thorax
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Pain - abdomen
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Metabolism and nutrition disorders
Potassium serum-low
|
5.6%
2/36 • Number of events 2 • 6 weeks per participant
|
|
Gastrointestinal disorders
Vomitting
|
5.6%
2/36 • Number of events 2 • 6 weeks per participant
|
Other adverse events
| Measure |
Eicosapentaenoic Acid (Lovaza)
n=36 participants at risk
Participants to receive Lovaza at a dose of 4 g for 6 weeks.
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
5.6%
2/36 • Number of events 2 • 6 weeks per participant
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
5.6%
2/36 • Number of events 2 • 6 weeks per participant
|
|
Gastrointestinal disorders
Anorexia
|
13.9%
5/36 • Number of events 6 • 6 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Bruising in absence of Grade 3 or 4 thrombocytopenia
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Gastrointestinal disorders
Constipation
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
2/36 • Number of events 3 • 6 weeks per participant
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Dizziness
|
5.6%
2/36 • Number of events 2 • 6 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
3/36 • Number of events 3 • 6 weeks per participant
|
|
Blood and lymphatic system disorders
Edema: limb
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Fatigue
|
30.6%
11/36 • Number of events 13 • 6 weeks per participant
|
|
Metabolism and nutrition disorders
Glucose, serum-high
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
13.9%
5/36 • Number of events 6 • 6 weeks per participant
|
|
Blood and lymphatic system disorders
Hemoglobin
|
8.3%
3/36 • Number of events 3 • 6 weeks per participant
|
|
Blood and lymphatic system disorders
Hemorrhage: nose
|
5.6%
2/36 • Number of events 2 • 6 weeks per participant
|
|
General disorders
Insomnia
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Blood and lymphatic system disorders
International Normalized Ratio of prothrombin time (INR)
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
5.6%
2/36 • Number of events 2 • 6 weeks per participant
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.8%
1/36 • Number of events 2 • 6 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
8.3%
3/36 • Number of events 3 • 6 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
2.8%
1/36 • Number of events 3 • 6 weeks per participant
|
|
Gastrointestinal disorders
Nausea
|
22.2%
8/36 • Number of events 9 • 6 weeks per participant
|
|
Musculoskeletal and connective tissue disorders
Neuropathy: sensory
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Eye disorders
Opthalmoplegia/diplopia (double vision)
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Pain - Chest/thorax NOS
|
5.6%
2/36 • Number of events 2 • 6 weeks per participant
|
|
General disorders
Pain - Extremity-limb
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Pain - back
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Pain - head/headache
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Pain - lymph node
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Pain - neck
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Pain - sinus
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Pain - stomach
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Blood and lymphatic system disorders
Partial Thromboplastin Time (PTT)
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Rigors/chills
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Metabolism and nutrition disorders
Sodium, serum-low
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
General disorders
Sweating
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Gastrointestinal disorders
Taste alteration
|
5.6%
2/36 • Number of events 2 • 6 weeks per participant
|
|
Renal and urinary disorders
Urine color change
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
4/36 • Number of events 6 • 6 weeks per participant
|
|
General disorders
Weight loss
|
2.8%
1/36 • Number of events 1 • 6 weeks per participant
|
Additional Information
Nagi Kumar, Ph.D., via Moffitt Cancer Center
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-6885
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place