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Cachexia; Cancer; SarcopeniaTELE-CACHENCT07606417

Telemedicine Nutritional Counseling for Cancer Cachexia in Pakistan

A study testing Telemedicine-Delivered Nutritional Counseling and Standard In-Person Nutritional Counseling in people with Cachexia; Cancer; Sarcopenia, run by King Edward Medical University at 1 site in Pakistan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cachexia; Cancer; Sarcopenia
What is being tested?
Telemedicine-Delivered Nutritional Counseling and Standard In-Person Nutritional Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 sitePakistan
Study dates
1 May 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 44Show fewer
  • 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

Who cannot join

  • 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
Show all 51Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Department of Radiotherapy and Medical Oncology, Mayo Hospital Lahore, 54000, Lahore, Pakistan.

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Telemedicine-Delivered Nutritional Counseling Versus Standard Care for Cancer Cachexia in Pakistani Cancer Patients: A Pilot Randomized Controlled Trial

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?

Read more

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

Read the detailed description

BACKGROUND AND RATIONALE Cancer cachexia is a metabolic syndrome characterized by progressive involuntary weight loss, skeletal muscle depletion, systemic inflammation, and anorexia, affecting 50-80% of cancer patients and contributing to 30% of cancer-related deaths. International guidelines from ESPEN and ASCO recommend nutritional counselling as a cornerstone of multimodal cachexia management; however, high-quality randomized evidence remains limited, particularly in low-and-middle-income countries.

In Pakistan, 31-97% of cancer patients experience malnutrition, compounded by geographic barriers, critical shortage of trained clinical nutritionists, and catastrophic out-of-pocket healthcare expenditure. No randomized controlled trial has evaluated telemedicine-delivered nutritional counselling for cancer cachexia anywhere in South Asia, representing a critical evidence gap.

STUDY DESIGN Single-centre, parallel-group, pilot randomized controlled trial with 1:1 allocation. Randomization is computer-generated with variable block sizes (4-6), stratified by cancer type (gastrointestinal vs. non-gastrointestinal) using sequentially numbered sealed opaque envelopes. The trial uses a single-blind design: outcomes assessors, laboratory staff, and the statistician are blinded to group allocation; participants and dietitians cannot be blinded due to the nature of the intervention.

INTERVENTION RATIONALE Both arms receive identical nutritional counselling content from the same registered dietitians following standardized ESPEN-based protocols (energy ≥25 kcal/kg/day; protein ≥1.0 g/kg/day), with culturally adapted Pakistani meal plans. Sessions are delivered bi-weekly at equal frequency (7 sessions over 12 weeks) so that delivery modality - not counselling dose - is the sole variable under study. The telemedicine arm uses WhatsApp Video Call as the primary platform (given its widespread use and low-bandwidth requirements in Pakistan), with Zoom or Microsoft Teams as alternatives. Patients participate from home; dietitians conduct sessions from a dedicated workspace at the Department of Medical Oncology, KEMU.

NON-INFERIORITY RATIONALE Given that both groups receive equivalent counselling frequency and content, a non-inferiority design is appropriate. The non-inferiority margin of -1.0 kg for body weight change at 12 weeks was selected based on clinical judgment and published cachexia literature, representing the maximum weight difference that would still be considered clinically acceptable for telemedicine to be adopted as a delivery alternative. Telemedicine will be declared non-inferior if the lower limit of the 95% confidence interval for mean weight difference (telemedicine minus standard care) exceeds -1.0 kg.

SAMPLE SIZE Using G*Power for an independent samples t-test: Cohen's d = 0.75, α = 0.05 (two-sided), power = 85%, yields 29 participants per group. Adjusted for 20% anticipated dropout in cancer cachexia trials, the final sample is 40 per group (80 total), with an expected evaluable sample of 64 participants.

STATISTICAL ANALYSIS Primary analysis is intention-to-treat. The primary outcome (body weight change, baseline to Week 12) will be analysed using an independent samples t-test or Mann-Whitney U test as appropriate, with ANCOVA adjusting for baseline weight, cancer type, ECOG performance status, and treatment changes during the study. Missing data will be handled by multiple imputation using chained equations (20 imputations) for <20% missingness, with complete case analysis as a sensitivity check. Per-protocol analysis (participants completing ≥75% of sessions) will be conducted as a secondary analysis. Exploratory subgroup analyses are planned by cancer type, baseline cachexia severity, sex, and urban versus rural residence.

SIGNIFICANCE This is the first RCT of telemedicine nutritional counselling for cancer cachexia in South Asia. The design isolates the effect of delivery modality by equalizing counselling frequency across arms. Results will provide effect size estimates to power a larger multi-centre trial, cost-effectiveness data for health policy decisions, and a scalable evidence-based model for nutritional care delivery in resource-constrained settings.

Being tested
Telemedicine-Delivered Nutritional Counseling, Standard In-Person Nutritional Counseling
Keywords
cachexia, nutritional counselling, telemedicine
Medical subject headings
Cachexia, Neoplasms, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemedicine-Delivered Nutritional CounselingBehavioural

    Also called Remote nutritional counseling, Video consultation nutrition therapy, Tele-nutrition

    Bi-weekly video consultation-based nutritional counseling delivered remotely via WhatsApp Video Call (primary platform), Zoom, or Microsoft Teams. Individual one-on-one sessions lasting 20-30 minutes conducted by registered dietitians from the hospital while patients participate from their homes.

  • Standard In-Person Nutritional CounselingBehavioural

    Also called Conventional nutrition counseling, Hospital-based nutritional counseling, Traditional nutritional counseling

    Bi-weekly in-person hospital-based nutritional counseling delivered at the hospital nutrition clinic. Individual face-to-face sessions lasting 30-45 minutes conducted by registered dietitians at the Department of Medical Oncology, King Edward Medical University/Mayo Hospital.

Study groups in NCT07606417
Study groupRoleWhat they receive
Telemedicine Nutritional CounselingExperimentalParticipants receive bi-weekly nutritional counseling via video consultations using WhatsApp Video Call (primary platform), Zoom, or Microsoft Teams for 12 weeks. Registered dietitians conduct sessions from the Department of Medical Oncology, King Edward Medical University, while patients participate from home or any convenient private location with internet access.
Receives: Behavioral: Telemedicine-Delivered Nutritional Counseling
Standard In-Person Nutritional CounselingActive comparatorParticipants receive bi-weekly nutritional counseling via traditional face-to-face hospital visits for 12 weeks. Registered dietitians conduct sessions at the hospital nutrition clinic, Department of Medical Oncology, King Edward Medical University/Mayo Hospital, Lahore.
Receives: Behavioral: Standard In-Person Nutritional Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body Weight From Baseline to 12 Weeks

    Mean change in body weight (measured in kilograms) from baseline (Week 0) to end of intervention (Week 12). Body weight is measured using a calibrated digital scale (±0.1 kg precision) with standardized protocol: patient wearing light clothing without shoes, with empty bladder, measured at consistent time of day. Higher positive values indicate weight gain; negative values indicate weight loss. The primary objective is to assess non-inferiority of telemedicine-delivered nutritional counseling compared to standard in-person counseling, with a non-inferiority margin of -1.0 kg. Body weight is a validated, objective, clinically meaningful outcome for cancer cachexia interventions and recommended by international guidelines (ESPEN, ASCO) as a key endpoint for nutritional intervention trials in oncology.

    Measured: Baseline (Week 0) and Week 12 (end of 12-week intervention period). Measurements also collected at Week 6 (mid-point) for trajectory analysis.

Secondary outcomes (6)

  1. Proportion of Participants Achieving Adequate Daily Energy Intake at 12 Weeks

    Proportion (percentage) of participants achieving adequate daily energy intake, operationally defined as ≥25 kilocalories per kilogram of actual or adjusted body weight per day, consistent with European Society for Clinical Nutrition and Metabolism (ESPEN) clinical practice guidelines for cancer patients. Energy intake assessed via two non-consecutive 24-hour dietary recalls (one weekday and one weekend day) conducted by trained dietitians using the validated USDA 5-step multiple-pass method. Dietary data analyzed using the Pakistani Food Composition Database from the National Institute of Health, Islamabad. Higher proportions indicate better nutritional adequacy. This outcome reflects the effectiveness of nutritional counseling interventions in improving actual dietary intake behaviors.

    Measured: Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary comparison at Week 12.

  2. Proportion of Participants Achieving Adequate Daily Protein Intake at 12 Weeks

    Proportion (percentage) of participants achieving adequate daily protein intake, operationally defined as ≥1.0 gram per kilogram of actual or adjusted body weight per day, consistent with ESPEN clinical practice guidelines for cancer patients. Protein intake assessed via two non-consecutive 24-hour dietary recalls (one weekday and one weekend day) conducted using the validated USDA 5-step multiple-pass method and analyzed using the Pakistani Food Composition Database. Higher proportions indicate better protein adequacy. Adequate protein intake is critical for preventing muscle wasting and supporting immune function during cancer treatment. This outcome measures the effectiveness of counseling in achieving evidence-based protein intake targets.

    Measured: Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary comparison at Week 12.

  3. Change in Mid-Upper Arm Circumference (MUAC) From Baseline to 12 Weeks

    Mean change in mid-upper arm circumference (MUAC) measured in centimeters as a proxy anthropometric measure for skeletal muscle mass. MUAC is measured on the non-dominant arm at the midpoint between the acromion process (shoulder) and olecranon process (elbow) using a non-stretchable measuring tape with the arm relaxed at the side, recorded to the nearest 0.1 cm by trained personnel following standardized protocol. MUAC <23 cm indicates malnutrition; decreases indicate muscle wasting (sarcopenia); increases indicate muscle gain. Higher positive change scores indicate muscle mass preservation or gain. MUAC is a validated, simple, low-cost anthropometric assessment tool recommended by WHO and FAO for nutritional surveillance in clinical populations and has been validated as a muscle mass surrogate in cancer cachexia research.

    Measured: Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.

  4. Change in Patient-Generated Subjective Global Assessment (PG-SGA) Score From Baseline to 12 Weeks

    Mean change in Patient-Generated Subjective Global Assessment (PG-SGA) total score from baseline to Week 12. The PG-SGA is the gold standard validated nutritional assessment instrument specifically developed and validated for cancer patients. The tool comprises a patient-completed section (weight history, food intake, nutrition impact symptoms, activities and function) and a professional-completed section (disease and metabolic stress, physical examination). Total score ranges from 0 to 35 points, with higher scores indicating greater malnutrition risk and severity. Score categories: well-nourished (0-1), moderately malnourished (2-8), severely malnourished (≥9). Negative change scores indicate nutritional improvement; positive change scores indicate deterioration. The PG-SGA has demonstrated reliability, validity, and sensitivity to change in multiple international studies and is recommended by the Oncology Nutrition Dietetic Practice Group of the Academy of Nutrition and Dietetics.

    Measured: Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.

  5. Change in Global Health Status/Quality of Life Score (EORTC QLQ-C30) From Baseline to 12 Weeks

    Mean change in the Global Health Status/Quality of Life (QoL) scale from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) from baseline to Week 12. The EORTC QLQ-C30 is a validated, cancer-specific, multidimensional health-related quality of life instrument comprising 30 items organized into functional scales (physical, role, emotional, cognitive, social functioning), symptom scales (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties), and a global health status/QoL scale. The global health status/QoL scale (items 29-30) is scored and linearly transformed to a 0-100 scale, where higher scores represent better quality of life. The validated Urdu version will be used. Positive change scores indicate QoL improvement. The EORTC QLQ-C30 has been extensively validated internationally including in Pakistani cancer populations and is recommended by EORTC for cancer

    Measured: Measured at baseline (Week 0) and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.

  6. Nutritional Counseling Session Adherence Rate Over 12 Weeks

    Session adherence rate calculated as the percentage of scheduled nutritional counseling sessions actually completed by the participant over the 12-week intervention period. Calculated as: (number of sessions attended ÷ number of sessions scheduled) × 100%. Total of 7 sessions are scheduled per participant at Weeks 0, 2, 4, 6, 8, 10, and 12. For the telemedicine group, a session is considered "attended" if the participant successfully joins the video call and completes the counseling session. For the standard care group, a session is considered "attended" if the participant presents for the in-person hospital visit and completes the session. Adherence ≥70% (completing ≥5 out of 7 sessions) is defined as good adherence based on behavioral intervention literature. Higher adherence rates indicate better intervention engagement and may predict better outcomes. Adherence is a key implementation outcome for assessing intervention feasibility and acceptability.

    Measured: Assessed continuously throughout the 12-week intervention period. Final adherence rate calculated at Week 12 (end of intervention).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2026
  2. Study start1 May 2026
  3. Primary completion1 May 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07606417
Sponsor's protocol ID
KEMU-IRB-337-RC-2026
Acronym
TELE-CACHE
Status last verified
Jun 2026
First submitted
19 May 2026
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared publicly to protect patient confidentiality and comply with institutional ethics requirements. The study involves vulnerable cancer patients with sensitive health information that could potentially identify individuals given the single-center setting.De-identified aggregate data may be shared upon reasonable request to the principal investigator after publication of primary results. Requests require: data sharing agreement, ethics approval, and compliance with Pakistani data protection regulations.This approach balances participant privacy protection with scientific transparency and enables future meta-analyses advancing cancer cachexia research.

Publications

  • Roeland EJ, Bohlke K, Baracos VE, Bruera E, Del Fabbro E, Dixon S, Fallon M, Herrstedt J, Lau H, Platek M, Rugo HS, Schnipper HH, Smith TJ, Tan W, Loprinzi CL. Management of Cancer Cachexia: ASCO Guideline. J Clin Oncol. 2020 Jul 20;38(21):2438-2453. doi: 10.1200/JCO.20.00611. Epub 2020 May 20.

    PubMed 32432946

  • Ng KLS, Munisamy M, Lim JBY, Alshagga M. The Effect of Nutritional Mobile Apps on Populations With Cancer: Systematic Review. JMIR Cancer. 2025 Feb 5;11:e50662. doi: 10.2196/50662.

    PubMed 39908548

  • Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15.

    PubMed 33946039

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine-Delivered Nutritional Counseling and Standard In-Person Nutritional Counseling in people with Cachexia; Cancer; Sarcopenia, run by King Edward Medical University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 44 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Weight From Baseline to 12 Weeks (time frame: Baseline (Week 0) and Week 12 (end of 12-week intervention period). Measurements also collected at Week 6 (mid-point) for trajectory analysis.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07606417, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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