Effect of Dietary Counseling and Nutritional Monitoring in Reducing Cancer-related Cachexia Among… (NCT07112482) | Clinical Trial Compass
CompletedNot Applicable
Effect of Dietary Counseling and Nutritional Monitoring in Reducing Cancer-related Cachexia Among Female Oncology Patients
Pakistan140 participantsStarted 2024-08-15
Plain-language summary
In this parallel, two-arm randomized controlled trial (RCT), 140 female patients with advanced-stage breast cancer and clinical features of cachexia will be randomized using block-stratified allocation into an intervention group (n = 70) and a control group (n = 70). The intervention group will receive standard oncological care along with personalized dietary counseling and monthly nutritional monitoring for six months, whereas the control group will receive standard care alone. The severity of cachexia will be assessed at baseline and follow-up using the Mini-CASCO tool, which will evaluate five domains: body composition, inflammatory-metabolic profile (C-reactive protein, serum albumin, hemoglobin, absolute lymphocyte count), physical performance (Eastern Cooperative Oncology Group \[ECOG\] status), anorexia (Simplified Nutritional Appetite Questionnaire \[SNAQ\]), and quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 \[EORTC QLQ-C30\]).
Who can participate
Age range
20 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female patients aged 20 to 60 years
. Histologically confirmed advanced breast cancer
. Documented unintentional weight loss of ≥5% over the past 6 months
. Hemoglobin level \<12 g/dL or average daily energy intake \<1500 kcal/day
. Ability to provide written and verbal informed consent
Exclusion criteria
. Malnutrition due to non-cancer causes (e.g., chronic starvation, eating disorders)
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.
What they're measuring
1
Change in cachexia severity measured by the Mini-CASCO composite score
. Presence of chronic gastrointestinal or endocrine disorders affecting nutritional status (e.g., Crohn's disease, Cushing's syndrome)
. Current pregnancy or lactation
. Concurrent diagnosis of another malignancy
. Any condition that, in the opinion of the investigator, may interfere with study participation or outcomes (e.g., severe psychiatric illness, cognitive impairment)