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Active Not Recruiting
NCT07606417
Telemedicine Nutritional Counseling for Cancer Cachexia in Pakistan
Conditions: Cachexia; Cancer; Sarcopenia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: King Edward Medical University
Location: Department of Radiotherapy and Medical Oncology, Mayo Hospital Lahore, 54000, Lahore, Pakistan. Lahore Punjab Province
Summary
What is this study about? Cancer often causes unwanted weight loss and loss of appetite, a condition called "cancer cachexia." This affects patients' strength, quality of life, and ability to tolerate cancer treatment. Proper nutrition is very important to help maintain weight and strength during cancer treatment. Currently, cancer patients receive nutritional counseling during hospital visits, which requires travel time and expense. With telemedicine (video calls on mobile phones), nutritional counseling can be provided from patients' homes.
What is the purpose of this study?
This study compares two ways of providing nutritional counseling to cancer patients who have experienced weight loss:
Telemedicine group: Counseling through video calls (WhatsApp, Zoom, or Microsoft Teams) from home Standard care group: Counseling during in-person hospital visits Both groups receive the same nutritional advice every 2 weeks for 12 weeks. The only difference is how the counseling is delivered (video call vs. in-person).
Who can participate? Adults (18 years or older) with cancer who have lost weight in recent months and have access to a smartphone with internet connection.
What will participants do?
Telemedicine group:
Receive counseling through 20-30 minute video calls every 2 weeks (7 sessions total) Come to hospital only twice: at the beginning and end (Week 0 and Week 12)
Standard care group:
Come to hospital every 2 weeks for 30-45 minute counseling sessions (7 visits total)
Both groups receive:
Personalized dietary advice from registered dietitians Help with eating problems (poor appetite, nausea, taste changes) Pakistani meal plans that fit their preferences Free nutritional counseling throughout the study Reimbursement for travel or mobile data costs
What will be measured? Body weight change over 12 weeks Food and protein intake Arm muscle measurements Nutritional status and quality of life Patient satisfaction with counseling method Costs of each method
Why is this study important? This will be the first study in Pakistan and South Asia to test whether telemedicine nutritional counseling works as well as hospital visits for cancer patients. Results will help make nutritional care more accessible, especially for patients living far from hospitals.
Study Location: King Edward Medical University/Mayo Hospital, Lahore, Pakistan Duration: 12 weeks per participant Total Participants Needed: 80 patients
Eligibility Criteria
Inclusion Criteria:
* 1\. Age and Consent Capacity
* Age ≥18 years (adults of either biological sex or gender identity)
* Able to understand study procedures and provide written informed consent independently or with assistance from legally authorized representative 2. Cancer Diagnosis
* Histologically or cytologically confirmed solid tumor malignancy of any type, including but not limited to:
* Lung cancer (non-small cell or small cell)
* Breast cancer
* Gastrointestinal cancers: gastric (stomach), colorectal, pancreatic, esophageal, hepatobiliary (liver, gallbladder, bile duct)
* Head and neck cancers (oral cavity, pharynx, larynx, nasal cavity, salivary glands)
* Gynecological cancers: cervical, ovarian, endometrial, vulvar, vaginal
* Genitourinary cancers: prostate, bladder, renal (kidney), testicular
* Other solid tumors: sarcomas, melanoma, thyroid, brain tumors
* Any cancer stage eligible (Stage I, II, III, or IV) 3. Cancer Cachexia
* Documented unintentional weight loss meeting at least one of the following criteria:
* Weight loss ≥3% of body weight within the past 3 months, OR
* Weight loss ≥5% of body weight within the past 6 months
* Weight loss must be documented by medical records, patient self-report, or measurement at screening visit compared to documented previous weight 4. Active Cancer Treatment
* Currently receiving active anti-cancer treatment, OR
* Scheduled to begin active anti-cancer treatment within 2 weeks of enrollment
* Eligible anti-cancer treatments include:
* Chemotherapy (cytotoxic agents, any regimen)
* Radiation therapy (external beam or brachytherapy)
* Targeted molecular therapy (tyrosine kinase inhibitors, monoclonal antibodies)
* Immunotherapy (checkpoint inhibitors, CAR-T cell therapy)
* Hormonal therapy for hormone-sensitive cancers
* Combination therapies
* Patients receiving palliative/supportive care only (without active anti-cancer treatment) are excluded 5. Performance Status
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2:
* Grade 0: Fully active; able to carry on all pre-disease activities without restriction
* Grade 1: Restricted in physically strenuous activity but ambulatory; able to carry out light or sedentary work (e.g., light housework, office work)
* Grade 2: Ambulatory and capable of all self-care activities but unable to carry out any work activities; up and about \>50% of waking hours 6. Technology Access and Literacy
* Access to a smartphone or tablet device with video calling capability (personal device or family member's device that participant can use)
* Reliable internet connectivity available via at least one of:
* Home Wi-Fi network
* Mobile cellular data plan (3G, 4G, or 5G)
* Access to public/community Wi-Fi
* For telemedicine group: willingness and ability to participate in video consultations 7. Language
* Able to communicate verbally in Urdu (national language of Pakistan) or English
* Able to understand spoken instructions and questions
* Literacy not required; illiterate participants eligible with assistance from family/witness for consent and questionnaires 8. Geography
* Able to attend in-person assessments at King Edward Medical University/Mayo Hospital, Lahore, Pakistan at baseline (Week 0) and Week 12
* For telemedicine group: only 2 hospital visits required (Weeks 0 and 12)
* For standard care group: able to attend 7 hospital visits (Weeks 0, 2, 4, 6, 8, 10, 12) 9. Commitment
* Willing to participate in the study for the full 12-week duration
* Willing to comply with study procedures including dietary assessments, questionnaires, blood tests, and nutritional counseling sessions
Exclusion Criteria:
* Inability to Eat Orally
* Severe dysphagia (difficulty swallowing) requiring enteral nutrition support via:
* Nasogastric tube feeding
* Percutaneous endoscopic gastrostomy (PEG) tube
* Jejunostomy tube
* Complete bowel obstruction preventing oral intake
* Total parenteral nutrition (TPN) as sole nutritional support
* Note: Partial oral intake supplemented with enteral nutrition is eligible if patient can consume at least some food by mouth 2. Refractory Cachexia
* ECOG Performance Status 3 or 4:
* Grade 3: Capable of only limited self-care; confined to bed or chair \>50% of waking hours
* Grade 4: Completely disabled; cannot carry out any self-care; totally confined to bed or chair
* Active cachexia management deemed not clinically appropriate or futile by treating oncologist
* Estimated life expectancy \
Source: ClinicalTrials.gov (NCT07606417). StuddyBuddy aggregates publicly available trial information.