Breast Cancer Early Stage Breast Cancer (Stage 1-3)IPENIPANCT06890221
Impact of PErioperative Nutrition Intervention on Bioimpedance Phase Angle (IPENIPA) In Breast Cancer Patients
A study testing B-Crobes intake complete nutrition in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Mastectomy Patient, run by University of Malaya at 1 site in Malaysia.
Trial summary
The goal of this clinical trial is to measure the mean difference of phase angle after nutritional intervention in breast cancer patients. The main question it aims to answer is: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Mastectomy Patient
- What is being tested?
- B-Crobes intake complete nutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteMalaysia
- Study dates
- 7 Mar 2025to 31 Dec 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Histopathologically confirmed operable breast cancer
- Aged 18 of years and above
- Consented and scheduled for mastectomy
Who cannot join
- On enteral supplementation prior to the study
- Lactose intolerance
- Pregnant or lactating
- Previous history of gastrectomy or small bowel resection surgery
- Advanced breast cancer staging, presence of pacemaker, decompensated liver disease, end stage renal failure, uncontrolled diabetes, on steroid therapy or complementary traditional medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Malaya Medical Centre
Petaling Jaya, Kuala Lumpur, 50603
Wai Yin Soo, MD, +60 16-3658711, waiyin@ummc.edu.my
Wai Yin Soo, MD
About this study
Official title: Impact of PErioperative Nutrition Intervention on Bioimpedance Phase Angle (IPENIPA) In Breast Cancer Patients: A Double-Blinded Randomized Controlled Trial
The goal of this clinical trial is to measure the mean difference of phase angle after nutritional intervention in breast cancer patients. The main question it aims to answer is:
- Can perioperative nutrition interventions improve phase angle in relation to other bioimpedance parameters, handgrip strength and surgical outcomes in breast cancer population?
Read more
Researchers will compare oral nutritional supplement to a placebo to see if oral nutritional supplement can improve phase angle.
Participants will:
- Be randomized into either arm
- Take oral nutritional supplement or placebo according to the result of randomization for 7 days preoperatively and 30 days postoperatively
- Have their measurements (weight, height, phase angle, handgrip strength) done at least 7 days preoperative, 1 day preoperative and 30 days postoperative
- Being tested
- B-Crobes intake complete nutrition, Placebo
- Keywords
- bioimpedance phase angle, nutritional intervention, oral nutritional supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-Crobes intake complete nutritionDietary supplement
Also called Oral nutrition supplement
Contains whey and plant based proteins, enriched with prebiotics and probiotics, Ca-Hmb, minerals and multivitamins.
PlaceboDietary supplement
Contains full cream dairy milk
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
| Cohort B | Active comparator | Oral nutrition supplement Receives: Dietary Supplement: B-Crobes intake complete nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference of phase angle after nutritional intervention
To measure the mean difference of phase angle between groups after nutritional intervention
Measured: From enrollment to 30 days post operation
Secondary outcomes (4)
Changes in handgrip strength
To study the changes on handgrip strength, body composition by bioimpedance analysis (skeletal muscle mass, skeletal muscle mass index, fat free mass and fat mass) after nutritional interventions.
Measured: From enrollment to 30 days post operation
Correlation of phase angle with bioimpedance analysis parameters
To describe the correlation of phase angle with nutritional status, handgrip strength, and body compositions by bioimpedance analysis (Skeletal muscle mass, skeletal muscle mass index, fat free mass, and fat mass).
Measured: From enrollment to 30 days post operation
Potential factors associated with postoperative complications
To identify the potential factors associated with complications and readmission in 30-days post-mastectomy participants.
Measured: From enrollment to 30 days post operation
Cutoff value of phase angle
To identify the cutoff value of PA in relation to GLIM malnutrition, nutrition risk, and sarcopenia
Measured: From enrollment to 30 days post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start7 Mar 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- B-Crobes Laboratory
- Responsible party
- Principal investigator, Soo Wai Yin, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890221
- Sponsor's protocol ID
- IPENIPA
- Other IDs
- MECID 2024521-13747, NMRR ID-24-01805-DNE
- Acronym
- IPENIPA
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of PErioperative Nutrition Intervention on Bioimpedance Phase Angle (IPENIPA) In Breast Cancer Patients: A Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06890221
- Acronym / sponsor ID
- IPENIPA / IPENIPA
- Keywords
- bioimpedance phase angle, nutritional intervention, oral nutritional supplement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- B-Crobes Laboratory
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Mar 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.
The goal of this clinical trial is to measure the mean difference of phase angle after nutritional intervention in breast cancer patients. The main question it aims to answer is:
- Can perioperative nutrition interventions improve phase angle in relation to other bioimpedance parameters, handgrip strength and surgical outcomes in breast cancer population?
Researchers will compare oral nutritional supplement to a placebo to see if oral nutritional supplement can improve phase angle.
Participants will:
- Be randomized into either arm
- Take oral nutritional supplement or placebo according to the result of randomization for 7 days preoperatively and 30 days postoperatively
- Have their measurements (weight, height, phase angle, handgrip strength) done at least 7 days preoperative, 1 day preoperative and 30 days postoperative
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
| Cohort B | Active comparator | Dietary Supplement: B-Crobes intake complete nutritionOral nutrition supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Histopathologically confirmed operable breast cancer
- Aged 18 of years and above
- Consented and scheduled for mastectomy
Key exclusion criteria (5 listed)
- On enteral supplementation prior to the study
- Lactose intolerance
- Pregnant or lactating
- Previous history of gastrectomy or small bowel resection surgery
- Advanced breast cancer staging, presence of pacemaker, decompensated liver disease, end stage renal failure, uncontrolled diabetes, on steroid therapy or complementary traditional medications
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 |
|---|---|---|
| B-Crobes intake complete nutritionAlso: Oral nutrition supplementContains whey and plant based proteins, enriched with prebiotics and probiotics, Ca-Hmb, minerals and multivitamins. | Dietary supplement | Cohort B |
| PlaceboContains full cream dairy milk | Dietary supplement | Cohort A |
Primary outcome
Mean difference of phase angle after nutritional intervention
Time frame: From enrollment to 30 days post operation
To measure the mean difference of phase angle between groups after nutritional intervention
4 secondary outcomes
Changes in handgrip strength
Time frame: From enrollment to 30 days post operation
Correlation of phase angle with bioimpedance analysis parameters
Time frame: From enrollment to 30 days post operation
Potential factors associated with postoperative complications
Time frame: From enrollment to 30 days post operation
Cutoff value of phase angle
Time frame: From enrollment to 30 days post operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-Crobes intake complete nutrition in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Mastectomy Patient, run by University of Malaya at 1 site in Malaysia.
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 4 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: looking for participants now, as of the sponsor's last update on 26 Mar 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 Malaysia. 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. Some participants in this study may receive a placebo. 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?
Contact Wai Yin Soo, MD (+60 16-365 8711, waiyin@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference of phase angle after nutritional intervention (time frame: From enrollment to 30 days post operation). 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 26 Mar 2025.