Telemedicine Nutritional Counseling for Cancer Cachexia in Pakistan

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 \<3 months per treating oncologist's assessment
  * Imminent end-of-life care or transition to hospice care 3. Uncontrolled Comorbid Conditions
  * Uncontrolled diabetes mellitus defined as:

    * Glycated hemoglobin (HbA1c) \>9% within past 3 months, OR
    * Frequent hypoglycemic or hyperglycemic episodes requiring emergency care
    * Rationale: Uncontrolled diabetes affects nutritional metabolism and requires specialized dietary management beyond scope of this intervention
  * End-stage renal disease requiring dialysis (hemodialysis or peritoneal dialysis)

    o Rationale: Dialysis patients require specialized renal diet with protein, fluid, potassium, and phosphorus restrictions that differ substantially from cancer cachexia nutritional recommendations
  * Severe heart failure, New York Heart Association (NYHA) Functional Class IV:

    * Symptoms at rest; any physical activity causes discomfort
    * Rationale: Severe cardiac cachexia has different pathophysiology and requires cardiology-directed nutritional management 4. Psychiatric or Cognitive Impairment
  * Active psychiatric illness that would preclude meaningful participation or informed consent, including:

    * Severe major depressive disorder with active suicidal ideation
    * Acute psychotic episode (schizophrenia, bipolar disorder with psychosis)
    * Severe anxiety disorder preventing participation in counseling sessions
  * Cognitive impairment preventing informed consent or ability to participate, including:

    * Advanced dementia (moderate to severe; unable to follow simple instructions)
    * Severe delirium (acute confusional state)
    * Significant brain metastases causing cognitive dysfunction
  * Note: Mild cognitive impairment or controlled psychiatric conditions with stable treatment are not exclusionary 5. Concurrent Study Participation
  * Currently enrolled in another interventional clinical trial testing nutritional interventions, dietary supplements, or appetite stimulants
  * Rationale: Concurrent nutritional interventions would confound outcome assessment
  * Note: Participation in observational studies, cancer treatment trials (chemotherapy, radiation), or non-nutritional supportive care trials is permitted 6. Pregnancy or Lactation
  * Pregnant women (confirmed by urine or serum pregnancy test if reproductive potential)
  * Breastfeeding/lactating women
  * Rationale: Pregnancy and lactation have substantially different and increased nutritional requirements that require specialized prenatal/postnatal nutritional counseling beyond the scope of cancer cachexia management in this protocol 7. Severe Food Allergies or Intolerances
  * Known severe allergy or intolerance to recommended nutritional supplements (oral nutrition supplements, protein powders, vitamins/minerals) for which no suitable alternatives are available in Pakistan
  * Note: Common food allergies (dairy, eggs, nuts) are not exclusionary as alternative food sources can be recommended 8. Logistical Barriers
  * Unable to attend baseline assessment visit (Week 0) at King Edward Medical University/Mayo Hospital, Lahore
  * Unable to attend final assessment visit (Week 12) at the hospital
  * For telemedicine group: Complete inability to access internet or use smartphone/tablet even with family assistance
  * No reliable means of contact (no phone number, no address) 9. Other
  * Enrolled in this study previously (re-enrollment not permitted)
  * Non-cancer-related causes of weight loss that would confound cachexia assessment:

    * Active eating disorder (anorexia nervosa, bulimia nervosa) requiring psychiatric treatment
    * Intentional weight loss through dieting for weight management
    * Hyperthyroidism causing unintentional weight loss (must be controlled before enrollment)
    * Active gastrointestinal infection (parasites, chronic diarrhea from infectious cause)
  * Any condition that, in the opinion of the principal investigator, would compromise patient safety, study integrity, or ability to complete study procedures