Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer (NCT00053053) | Clinical Trial Compass
CompletedPhase 3
Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
United States, Canada472 participantsStarted 2002-12
Plain-language summary
RATIONALE: Nutritional supplements may help prevent loss of appetite, weight loss, and fatigue in patients with advanced cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two nutritional supplements in preventing loss of appetite, weight loss, and fatigue in patients who have stage III or stage IV solid tumors.
Who can participate
Age range
17 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed solid tumor or lymphoma with no leukemic aspect
* Stage III or IV or any other stage associated with current metastatic disease at presentation
* No primary or metastatic brain tumors
* Weight loss of at least 2% but no more than 10% within the past 3 months
* No ascites
PATIENT CHARACTERISTICS:
Age
* 17 and over
Performance status
* Zubrod 0-2
Life expectancy
* At least 3 months
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* No hypercalcemia
Cardiovascular
* No persistent moderate or severe peripheral edema
* No uncontrolled congestive heart failure
Gastrointestinal
* No enteric fistula
* No concurrent intestinal obstruction
* Prior intestinal obstruction allowed
Other
* Not pregnant or nursing
* Negative pregnancy test
* No uncontrolled infections
* No other serious medical illness
* No metabolic disorder
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Concurrent chemotherapy allowed
Endocrine therapy
* No dexamethasone as an appetite stimulant
* Intermittent dexamethasone during concurrent chemotherapy allowed
Radiotherapy
* Concurrent radiotherapy allowed
Surgery
* At least 1 week since prior minor surgery
* At least 3 weeks since prior major surgery
Other
* At least 30 days since prior total parenteral nutrition
* No concurrent parenteral feedings
* No concurrent known appetite stimulants (e.g., megestrol or dronabinol)
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.