Cancer of BreastNCT04400552
Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients
A study testing ONS Pre-op + ONS Post-op, ONS Pre-op + ONS Post-op + ONS Post-op 3 months and Usual intake Pre-op + ONS Post-op in people with Cancer of Breast and Cancer Colon, run by IMU University, Malaysia at 1 site in Malaysia.
Trial summary
The aim of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ONS) on nutritional status in malnourished cancer patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Cancer of Breast, Cancer Colon
- What is being tested?
- ONS Pre-op + ONS Post-op, ONS Pre-op + ONS Post-op + ONS Post-op 3 months and Usual intake Pre-op + ONS Post-op
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteMalaysia
- Study dates
- 26 Dec 2018to 30 Jun 2021
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female from all ethnicity
- 25 to 65 years
- BMI not less than 18.0 kg/m²
- Cancer patients who are confirmed with elective surgery whose co-morbidities are stabilized based on the ASA Physical Status Classification System ASA Class 1 and 2
- Fulfil at least two characteristics of AND/ ASPEN Diagnosis of Malnutrition These characteristics are insufficient energy intake, weight loss, loss of muscle mass, loss of subcutaneous fat, localized or generalized fluid accumulation and diminished functional status as measured by handgrip strength.
Who cannot join
- Patients who require enteral or parenteral feeding
- Pregnant or lactating
- On chemotherapy or radiotherapy
- Total gastrectomy or ileostomy
- Metastasized cancer, upper gastrointestinal cancer, terminal diseases, decompensated liver or renal disease, major concurrent metabolic problem such as uncontrolled diabetes, dementia
- On regular steroids prescription
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients- A Randomized Controlled Trial
The aim of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ONS) on nutritional status in malnourished cancer patients undergoing elective surgery.
The hypothesis is pre-operative ONS feeding in malnourished surgical cancer patients is effective on improving nutritional status. An extended period of 3 months post-operative ONS feeding is effective on improving nutritional status as compared to ONS feeding post-operatively during hospital stay only. Perioperative feeding is effective on improving secondary outcomes such as sleep quality, post-operative complications and length of hospital stay.
Read the detailed description
The main objective of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ONS) on nutritional status in malnourished cancer patients undergoing elective surgery.
The specific objectives are:
- To evaluate the baseline nutritional status of cancer patients undergoing elective surgery
- To evaluate the effectiveness of pre-operative ONS feeding on nutritional status in malnourished surgical cancer patients
- To evaluate the effectiveness of an extended 3 months post-operative ONS feeding after discharge versus ONS feeding only post-operatively during hospital on nutritional status
- To evaluate secondary outcomes of perioperative feeding such as sleep quality, post-operative complications and length of hospital stay
Study Design: This is a randomised-controlled-open label-parallel group(s)-trial which will be conducted on malnourished cancer patients undergoing elective surgery.
Study duration: The participation duration for each participant is 4 months. The completion of the study will take around 30 months.
- Conditions
- Cancer of Breast, Cancer Colon
- Being tested
- ONS Pre-op + ONS Post-op, ONS Pre-op + ONS Post-op + ONS Post-op 3 months, Usual intake Pre-op + ONS Post-op
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONS Pre-op + ONS Post-opDietary supplement
Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively and post-operatively up to participants being discharged from the hospital.
ONS Pre-op + ONS Post-op + ONS Post-op 3 monthsDietary supplement
Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively, post-operatively up to participants being discharged from the hospital and an extended oral nutrition supplementation post-operatively up to 3 months.
Usual intake Pre-op + ONS Post-opDietary supplement
Participants will follow a meal plan of 2000 kcal / day using conventional foods for 14 days pre-operatively and consume oral nutrition supplementation (ONS) in addition to normal diet post-operatively up to participants being discharged from the hospital
| Study group | Role | What they receive |
|---|---|---|
| ONS Pre-op + ONS Post-op | Active comparator | Oral nutrition supplementation (ONS) pre-operatively and post-operatively up to being discharged from hospital Receives: Dietary Supplement: ONS Pre-op + ONS Post-op |
| ONS Pre-op + ONS Post-op + ONS Post-op 3 months | Active comparator | Oral nutrition supplementation (ONS) pre-operatively, post-operatively up to being discharged from hospital and an extended oral nutrition supplementation post-operatively up to 3 months Receives: Dietary Supplement: ONS Pre-op + ONS Post-op + ONS Post-op 3 months |
| Usual intake Pre-op + ONS Post-op | Active comparator | Follow a meal plan of 2000 kcal / day using conventional foods and oral nutrition supplementation (ONS) post-operatively up to being discharged from hospital Receives: Dietary Supplement: Usual intake Pre-op + ONS Post-op |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Anthropometry measurement
Measured: Change from baseline body weight at 4 months
Change in body mass index (BMI)
Anthropometry measurement
Measured: Change from baseline body mass index (BMI) at 4 months
Change in serum albumin level
Serum albumin is an indicator of protein stores to assess nutritional status
Measured: Change from baseline serum albumin level at 4 months
Change in serum pre-albumin level
Serum pre-albumin is an indicator of protein stores to assess nutritional status
Measured: Change from baseline serum pre-albumin level at 4 months
Secondary outcomes (13)
Change in handgrip force
Handgrip force is a measure of handgrip strength by dynamometer
Measured: Change from baseline handgrip force at 4 months
Change in muscle mass
Muscle mass reported in kilogram is measured by bioelectrical impedance analyser
Measured: Change from baseline muscle mass at 4 months
Change in fat mass
Fat mass reported in kilogram is measured by bioelectrical impedance analyser
Measured: Change from baseline fat mass at 4 months
Change in serum transferrin level
Serum transferrin is a measure of nutritional status
Measured: Change from baseline serum transferrin level at 4 months
Change in hemoglobin level
Serum hemoglobin is a measure of nutritional status
Measured: Change from baseline hemoglobin level at 4 months
Change in high sensitivity c-reactive protein (HsCRP) level
High sensitivity c-reactive protein (HsCRP) is a measure of inflammatory status
Measured: Change from baseline high sensitivity c-reactive protein (HsCRP) level at 4 months
Change in Interleukin-6 (IL-6)
Interleukin-6 (IL-6) is a measure of inflammatory status
Measured: Change from baseline Interleukin-6 (IL-6) at 4 months
Change in salivary cortisol level
Salivary cortisol level is a biological marker of stress reaction
Measured: Change from baseline salivary cortisol level at 4 months
Change in energy intake
Energy intake reported in calories is a dietary measure to assess nutritional status
Measured: Change from baseline energy intake at 4 months
Change in protein intake
Protein intake reported in gram is a dietary measure to assess nutritional status
Measured: Change from baseline protein intake at 4 months
Change in Pittsburgh Sleep Quality Index (PSQI) scores
Pittsburgh Sleep Quality Index (PSQI) scores range from 0-42.Higher scores indicate poorer sleep quality
Measured: Change from baseline Pittsburgh Sleep Quality Index (PSQI) scores at 4 months
Presence of post-surgical complications
Post-surgical complications are indicated by presence of wound infection, chest infection and use of antibiotics, responses are either yes or no
Measured: Change from baseline post-surgical complications at 3 months
Length of hospital stay
Number of days participants are admitted into the hospital
Measured: Up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start26 Dec 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of BreastStudies 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
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMU University, Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Kotra Pharma (M) Sdn Bhd
- Responsible party
- Principal investigator, Winnie Chee, IMU University, Malaysia
- Investigators
- Winnie SS Chee, PhD, Principal investigator, IMU University, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400552
- Sponsor's protocol ID
- IMU R204/2017
- Status last verified
- Aug 2021
- First submitted
- 28 Apr 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong TX, Chen ST, Ong SH, Shyam S, Kandasami P, Chee WSS. Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery. Trials. 2021 Nov 3;22(1):767. doi: 10.1186/s13063-021-05716-5.
PubMed 34732233
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04400552
- Acronym / sponsor ID
- IMU R204/2017
- Conditions
- Cancer of Breast, Cancer Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- IMU University, MalaysiaUniversity, hospital or other
- Collaborators
- Kotra Pharma (M) Sdn Bhd
- Study start
- 26 Dec 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 22 May 2020 (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 aim of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ONS) on nutritional status in malnourished cancer patients undergoing elective surgery.
The hypothesis is pre-operative ONS feeding in malnourished surgical cancer patients is effective on improving nutritional status. An extended period of 3 months post-operative ONS feeding is effective on improving nutritional status as compared to ONS feeding post-operatively during hospital stay only. Perioperative feeding is effective on improving secondary outcomes such as sleep quality, post-operative complications and length of hospital stay.
Detailed description
The main objective of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ONS) on nutritional status in malnourished cancer patients undergoing elective surgery.
The specific objectives are:
- To evaluate the baseline nutritional status of cancer patients undergoing elective surgery
- To evaluate the effectiveness of pre-operative ONS feeding on nutritional status in malnourished surgical cancer patients
- To evaluate the effectiveness of an extended 3 months post-operative ONS feeding after discharge versus ONS feeding only post-operatively during hospital on nutritional status
- To evaluate secondary outcomes of perioperative feeding such as sleep quality, post-operative complications and length of hospital stay
Study Design: This is a randomised-controlled-open label-parallel group(s)-trial which will be conducted on malnourished cancer patients undergoing elective surgery.
Study duration: The participation duration for each participant is 4 months. The completion of the study will take around 30 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| ONS Pre-op + ONS Post-op | Active comparator | Dietary Supplement: ONS Pre-op + ONS Post-opOral nutrition supplementation (ONS) pre-operatively and post-operatively up to being discharged from hospital |
| ONS Pre-op + ONS Post-op + ONS Post-op 3 months | Active comparator | Dietary Supplement: ONS Pre-op + ONS Post-op + ONS Post-op 3 monthsOral nutrition supplementation (ONS) pre-operatively, post-operatively up to being discharged from hospital and an extended oral nutrition supplementation post-operatively up to 3 months |
| Usual intake Pre-op + ONS Post-op | Active comparator | Dietary Supplement: Usual intake Pre-op + ONS Post-opFollow a meal plan of 2000 kcal / day using conventional foods and oral nutrition supplementation (ONS) post-operatively up to being discharged from hospital |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female from all ethnicity
- 25 to 65 years
- BMI not less than 18.0 kg/m²
- Cancer patients who are confirmed with elective surgery whose co-morbidities are stabilized based on the ASA Physical Status Classification System ASA Class 1 and 2
- Fulfil at least two characteristics of AND/ ASPEN Diagnosis of Malnutrition These characteristics are insufficient energy intake, weight loss, loss of muscle mass, loss of subcutaneous fat, localized or generalized fluid accumulation and diminished functional status as measured by handgrip strength.
Key exclusion criteria (6 listed)
- Patients who require enteral or parenteral feeding
- Pregnant or lactating
- On chemotherapy or radiotherapy
- Total gastrectomy or ileostomy
- Metastasized cancer, upper gastrointestinal cancer, terminal diseases, decompensated liver or renal disease, major concurrent metabolic problem such as uncontrolled diabetes, dementia
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 |
|---|---|---|
| ONS Pre-op + ONS Post-opParticipants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively and post-operatively up to participants being discharged from the hospital. | Dietary supplement | ONS Pre-op + ONS Post-op |
| ONS Pre-op + ONS Post-op + ONS Post-op 3 monthsParticipants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively, post-operatively up to participants being discharged from the hospital and an extended oral nutrition supplementation post-operatively up to 3 months. | Dietary supplement | ONS Pre-op + ONS Post-op + ONS Post-op 3 months |
| Usual intake Pre-op + ONS Post-opParticipants will follow a meal plan of 2000 kcal / day using conventional foods for 14 days pre-operatively and consume oral nutrition supplementation (ONS) in addition to normal diet post-operatively up to participants being discharged from the hospital | Dietary supplement | Usual intake Pre-op + ONS Post-op |
Primary outcome
Change in body weight
Time frame: Change from baseline body weight at 4 months
Anthropometry measurement
Change in body mass index (BMI)
Time frame: Change from baseline body mass index (BMI) at 4 months
Anthropometry measurement
Change in serum albumin level
Time frame: Change from baseline serum albumin level at 4 months
Serum albumin is an indicator of protein stores to assess nutritional status
Change in serum pre-albumin level
Time frame: Change from baseline serum pre-albumin level at 4 months
Serum pre-albumin is an indicator of protein stores to assess nutritional status
13 secondary outcomes
Change in handgrip force
Time frame: Change from baseline handgrip force at 4 months
Change in muscle mass
Time frame: Change from baseline muscle mass at 4 months
Change in fat mass
Time frame: Change from baseline fat mass at 4 months
Change in serum transferrin level
Time frame: Change from baseline serum transferrin level at 4 months
Change in hemoglobin level
Time frame: Change from baseline hemoglobin level at 4 months
Change in high sensitivity c-reactive protein (HsCRP) level
Time frame: Change from baseline high sensitivity c-reactive protein (HsCRP) level at 4 months
Change in Interleukin-6 (IL-6)
Time frame: Change from baseline Interleukin-6 (IL-6) at 4 months
Change in salivary cortisol level
Time frame: Change from baseline salivary cortisol level at 4 months
Change in energy intake
Time frame: Change from baseline energy intake at 4 months
Change in protein intake
Time frame: Change from baseline protein intake at 4 months
Change in Pittsburgh Sleep Quality Index (PSQI) scores
Time frame: Change from baseline Pittsburgh Sleep Quality Index (PSQI) scores at 4 months
Presence of post-surgical complications
Time frame: Change from baseline post-surgical complications at 3 months
Length of hospital stay
Time frame: Up to 5 days
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 25 Aug 2021.
- Derived from this study: PubMed 34732233Wong TX, Chen ST, Ong SH, Shyam S, Kandasami P, Chee WSS. Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery. Trials. 2021 Nov 3;22(1):767. doi: 10.1186/s13063-021-05716-5.
- Individual participant dataSharing planned: No
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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.
Winnie SS Chee, PhD principal investigator
IMU University, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONS Pre-op + ONS Post-op, ONS Pre-op + ONS Post-op + ONS Post-op 3 months and Usual intake Pre-op + ONS Post-op in people with Cancer of Breast and Cancer Colon, run by IMU University, Malaysia 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 5 inclusion and 6 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 25 Aug 2021. 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. 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 body weight (time frame: Change from baseline body weight at 4 months). The study lists 4 primary outcomes in all. 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 NCT04400552, which also lists 1 linked publication.
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 25 Aug 2021.