Breast CancerNCT07112482
Effect of Dietary Counseling and Nutritional Monitoring in Reducing Cancer-related Cachexia Among Female Oncology Patients
A study testing Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring in people with Breast Cancer and Cachexia, run by Pakistan Society of Pediatric Oncology at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cachexia
- What is being tested?
- Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Malnutrition due to non-cancer causes (e.g., chronic starvation, eating disorders)
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Cachexia Status in Pakistani Cancer Patients Using the Mini-CASCO Score
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]).
Read the detailed description
This randomized controlled trial evaluates the impact of individualized dietary counseling with ongoing nutritional monitoring on cancer cachexia severity in women with advanced breast cancer. Cancer cachexia is a multifactorial syndrome characterized by muscle wasting, anorexia, inflammation, and reduced functional status, significantly impairing quality of life and treatment tolerance. Despite its clinical relevance, targeted interventions for cachexia remain underutilized in routine oncology care.
The study is designed as a two-arm, parallel-group trial comparing standard oncological care alone with standard care plus a tailored nutritional intervention. The intervention is structured to address energy and protein intake requirements using individualized plans developed by a clinical dietitian. It incorporates scheduled nutritional counseling sessions, structured adherence monitoring through food logs and checklists, and reinforcement strategies including light physical activity promotion and psychosocial support.
To ensure methodological rigor, the study employs block-stratified randomization with concealed allocation using opaque, sealed envelopes. While blinding of participants and care providers is not feasible due to the nature of the intervention, outcome assessors and data analysts will be blinded to minimize bias. The primary outcome-change in cachexia severity over six months-will be evaluated using a validated multidimensional tool that captures clinical, functional, and patient-reported parameters.
Data will be entered into a secure, password-protected database with built-in quality control processes, including double data entry and discrepancy checks. Missing data will be handled using multiple imputation under the assumption of missing at random. Statistical analyses will be conducted on an intention-to-treat basis, with appropriate covariate adjustment and effect size reporting.
This trial is expected to provide practical evidence on the feasibility and effectiveness of structured, individualized nutritional interventions as part of supportive oncology care in resource-constrained settings.
- Conditions
- Breast Cancer, Cachexia
- Being tested
- Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring
- Keywords
- Cancer-associated cachexia, Randomize Controlled Trail, Dietary Counselling, Nutritional Monitoring, Breast cancer
- Medical subject headings
- Breast Neoplasms, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Oncological Care + Tailored Dietary Counseling + Nutritional MonitoringBehavioural
Participants in this group will receive:
Standard oncological care (e.g., chemotherapy and routine cancer treatments)
Individualized dietary counseling: Nutrition plans tailored by a clinical dietitian to meet energy needs (25-30 kcal/kg/day) and protein needs (1.2-1.5 g/kg/day), adapted to clinical status, dietary tolerance, and treatment side effects.
Regular nutritional monitoring: Counseling sessions every 15-21 days over a period of six months.
Dietary adherence tracking: Through structured food records and goal adherence checklists.
Light physical activity guidance: Encouragement to engage in low-intensity activity suited to patient capacity.
Psychosocial support: Sessions with a certified clinical psychologist addressing emotional distress, fatigue, and anorexia.
Adherence criteria: Defined as attending ≥75% of sessions and meeting ≥80% of dietary goals.
| Study group | Role | What they receive |
|---|---|---|
| Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring | Experimental | Participants in the intervention group will receive:
Standard oncological care (including chemotherapy and other routine cancer treatments) plus
Individualized dietary counseling: Tailored nutrition plans developed by a clinical dietitian based on energy (25-30 kcal/kg/day) and protein (1.2-1.5 g/kg/day) needs, adjusted for clinical status, dietary tolerance, and treatment side effects.
Regular nutritional monitoring: Counseling sessions every 15-21 days over a period of six months.
Dietary adherence tracking: Using structured food records and goal adherence checklists.
Light physical activity guidance: Encouragement to engage in low-intensity activity appropriate to patient capacity.
Psychosocial support: Sessions with a certified clinical psychologist to address emotional distress, fatigue, and anorexia.
Adherence criteria: Defined as attending ≥75% of sessions and meeting ≥80% of dietary goals. Receives: Behavioral: Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring |
| Standard Oncological Care | Active comparator | Participants in this group will receive standard oncological care only, including chemotherapy and other routine cancer treatments, without additional dietary or psychosocial interventions. Receives: Behavioral: Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cachexia severity measured by the Mini-CASCO composite score
The primary outcome will be the change in cachexia severity from baseline to six months, measured using Mini-CASCO, which includes:
Body Composition (40%): Body weight and lean body mass assessed by digital scale and BIA.
Inflammatory/Metabolic/Immune Status (20%): CRP, albumin, hemoglobin, and lymphocyte count.
Physical Performance (15%): ECOG scale, handgrip strength, stair climbing, and fatigue assessments.
Anorexia (15%): SNAQ scores, 24-hour recall, and food frequency questionnaires.
The Mini-Cancer Cachexia Score (Mini-CASCO) is a validated multidimensional scoring system that assesses cancer cachexia severity using five domains: body composition, inflammation/metabolism, physical performance, anorexia, and quality of life. The total score ranges from 0 to 100, with higher scores indicating more severe cachexia.
Measured: From baseline to 6 months
Secondary outcomes (6)
Change in Body Weight
Change in body weight measured using a calibrated digital scale.
Measured: From baseline to 6 months
Change in Lean Body Mass
Kilograms (kg) Description: Change in lean mass assessed via Bioelectrical Impedance Analysis (BIA).
Measured: From baseline to 6 months
Change in C-Reactive Protein (CRP)
Description: Assessed as a marker of systemic inflammation. Milligrams per liter (mg/L)
Measured: From baseline to 6 months
Change in ECOG Performance Status
Eastern Cooperative Oncology Group (ECOG) performance score; higher values indicate worse performance. ECOG scale (0-5)
Measured: From baseline to 6 months
Change in SNAQ Score (Simplified Nutritional Appetite Questionnaire)
Lower scores indicate higher risk of weight loss. SNAQ score (4-20)
Measured: From baseline to 6 months
Change in Quality of Life (EORTC QLQ-C30, Urdu version)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30), global health status scale; higher scores indicate better quality of life. Global Health Status/QoL scale (0-100)
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start15 Aug 2024
- Primary completion30 Jun 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group will receive standard oncological care along with tailored dietary counseling and monthly nutritional monitoring for six months. Plans will target 25-30 kcal/kg/day and 1.2-1.5 g/kg/day protein intake, adapted to clinical condition, treatment tolerance, and preferences. Counseling sessions (every 15-21 days) will last 25-30 minutes and address dietary challenges, food tolerance, and symptom-related barriers. Dietary adherence will be tracked using structured food logs and checklists. Light physical activity and psychosocial support will be encouraged. Adherence will be defined as ≥75% session attendance and ≥80% dietary goal achievement.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Society of Pediatric Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Pakistan Institute of Medical Sciences
- Responsible party
- Principal investigator, Junaid Jamshed, Pakistan Society of Pediatric Oncology
- Investigators
- Clinical Research Coordinator, MSPH, DrPH, Study chair, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112482
- Sponsor's protocol ID
- 794/RC/FFH/RWP
- Status last verified
- Aug 2025
- First submitted
- 16 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, individual participant data (IPD) will be shared. The following data will be shared: de-identified demographic data, baseline characteristics, outcome data, and adverse events. Data will be available beginning 6 months after publication and will be shared for a period of 3 years. Data will be accessible to researchers with a methodologically sound proposal via a secure data-sharing platform, upon request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Cachexia Status in Pakistani Cancer Patients Using the Mini-CASCO Score
- ClinicalTrials.gov ID
- NCT07112482
- Acronym / sponsor ID
- 794/RC/FFH/RWP
- Conditions
- Breast Cancer, Cachexia
- Keywords
- Cancer-associated cachexia, Randomize Controlled Trail, Dietary Counselling, Nutritional Monitoring, Breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Pakistan Society of Pediatric OncologyUniversity, hospital or other
- Collaborators
- Pakistan Institute of Medical Sciences
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Detailed description
This randomized controlled trial evaluates the impact of individualized dietary counseling with ongoing nutritional monitoring on cancer cachexia severity in women with advanced breast cancer. Cancer cachexia is a multifactorial syndrome characterized by muscle wasting, anorexia, inflammation, and reduced functional status, significantly impairing quality of life and treatment tolerance. Despite its clinical relevance, targeted interventions for cachexia remain underutilized in routine oncology care.
The study is designed as a two-arm, parallel-group trial comparing standard oncological care alone with standard care plus a tailored nutritional intervention. The intervention is structured to address energy and protein intake requirements using individualized plans developed by a clinical dietitian. It incorporates scheduled nutritional counseling sessions, structured adherence monitoring through food logs and checklists, and reinforcement strategies including light physical activity promotion and psychosocial support.
To ensure methodological rigor, the study employs block-stratified randomization with concealed allocation using opaque, sealed envelopes. While blinding of participants and care providers is not feasible due to the nature of the intervention, outcome assessors and data analysts will be blinded to minimize bias. The primary outcome-change in cachexia severity over six months-will be evaluated using a validated multidimensional tool that captures clinical, functional, and patient-reported parameters.
Data will be entered into a secure, password-protected database with built-in quality control processes, including double data entry and discrepancy checks. Missing data will be handled using multiple imputation under the assumption of missing at random. Statistical analyses will be conducted on an intention-to-treat basis, with appropriate covariate adjustment and effect size reporting.
This trial is expected to provide practical evidence on the feasibility and effectiveness of structured, individualized nutritional interventions as part of supportive oncology care in resource-constrained settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention group will receive standard oncological care along with tailored dietary counseling and monthly nutritional monitoring for six months. Plans will target 25-30 kcal/kg/day and 1.2-1.5 g/kg/day protein intake, adapted to clinical condition, treatment tolerance, and preferences. Counseling sessions (every 15-21 days) will last 25-30 minutes and address dietary challenges, food tolerance, and symptom-related barriers. Dietary adherence will be tracked using structured food logs and checklists. Light physical activity and psychosocial support will be encouraged. Adherence will be defined as ≥75% session attendance and ≥80% dietary goal achievement.
| Arm | Type | Receives |
|---|---|---|
| Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring | Experimental | Behavioral: Standard Oncological Care + Tailored Dietary Counseling + Nutritional MonitoringParticipants in the intervention group will receive: Standard oncological care (including chemotherapy and other routine cancer treatments) plus Individualized dietary counseling: Tailored nutrition plans developed by a clinical dietitian based on energy (25-30 kcal/kg/day) and protein (1.2-1.5 g/kg/day) needs, adjusted for clinical status, dietary tolerance, and treatment side effects. Regular nutritional monitoring: Counseling sessions every 15-21 days over a period of six months. Dietary adherence tracking: Using structured food records and goal adherence checklists. Light physical activity guidance: Encouragement to engage in low-intensity activity appropriate to patient capacity. Psychosocial support: Sessions with a certified clinical psychologist to address emotional distress, fatigue, and anorexia. Adherence criteria: Defined as attending ≥75% of sessions and meeting ≥80% of dietary goals. |
| Standard Oncological Care | Active comparator | Behavioral: Standard Oncological Care + Tailored Dietary Counseling + Nutritional MonitoringParticipants in this group will receive standard oncological care only, including chemotherapy and other routine cancer treatments, without additional dietary or psychosocial interventions. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Malnutrition due to non-cancer causes (e.g., chronic starvation, eating disorders)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Oncological Care + Tailored Dietary Counseling + Nutritional MonitoringParticipants in this group will receive: Standard oncological care (e.g., chemotherapy and routine cancer treatments) Individualized dietary counseling: Nutrition plans tailored by a clinical dietitian to meet energy needs (25-30 kcal/kg/day) and protein needs (1.2-1.5 g/kg/day), adapted to clinical status, dietary tolerance, and treatment side effects. Regular nutritional monitoring: Counseling sessions every 15-21 days over a period of six months. Dietary adherence tracking: Through structured food records and goal adherence checklists. Light physical activity guidance: Encouragement to engage in low-intensity activity suited to patient capacity. Psychosocial support: Sessions with a certified clinical psychologist addressing emotional distress, fatigue, and anorexia. Adherence criteria: Defined as attending ≥75% of sessions and meeting ≥80% of dietary goals. | Behavioural | Standard Oncological Care, Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring |
Primary outcome
Change in cachexia severity measured by the Mini-CASCO composite score
Time frame: From baseline to 6 months
The primary outcome will be the change in cachexia severity from baseline to six months, measured using Mini-CASCO, which includes: Body Composition (40%): Body weight and lean body mass assessed by digital scale and BIA. Inflammatory/Metabolic/Immune Status (20%): CRP, albumin, hemoglobin, and lymphocyte count. Physical Performance (15%): ECOG scale, handgrip strength, stair climbing, and fatigue assessments. Anorexia (15%): SNAQ scores, 24-hour recall, and food frequency questionnaires. The Mini-Cancer Cachexia Score (Mini-CASCO) is a validated multidimensional scoring system that assesses cancer cachexia severity using five domains: body composition, inflammation/metabolism, physical performance, anorexia, and quality of life. The total score ranges from 0 to 100, with higher scores indicating more severe cachexia.
6 secondary outcomes
Change in Body Weight
Time frame: From baseline to 6 months
Change in Lean Body Mass
Time frame: From baseline to 6 months
Change in C-Reactive Protein (CRP)
Time frame: From baseline to 6 months
Change in ECOG Performance Status
Time frame: From baseline to 6 months
Change in SNAQ Score (Simplified Nutritional Appetite Questionnaire)
Time frame: From baseline to 6 months
Change in Quality of Life (EORTC QLQ-C30, Urdu version)
Time frame: From baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Yes. Yes, individual participant data (IPD) will be shared. The following data will be shared: de-identified demographic data, baseline characteristics, outcome data, and adverse events. Data will be available beginning 6 months after publication and will be shared for a period of 3 years. Data will be accessible to researchers with a methodologically sound proposal via a secure data-sharing platform, upon request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Research Coordinator, MSPH, DrPH study chair
Pakistan Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Oncological Care + Tailored Dietary Counseling + Nutritional Monitoring in people with Breast Cancer and Cachexia, run by Pakistan Society of Pediatric Oncology 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 11 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 cachexia severity measured by the Mini-CASCO composite score (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2025.