Colorectal CancerNCT04567459
The Effect of Nutrition for the Colorectal Cancer Patients Receiving Chemotherapy-randomized Controlled Study
A study testing Premium Amino Acids in people with Colorectal Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
We use clinical trial to explore the effect of nutrition support in colorectal cancer patients receiving postoperative adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Premium Amino Acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Jan 2021to 22 Feb 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 20
- Radical operation for stage III and stage II with high risk colorectal cancer
- Agree to join the trial and sign the informed consent form
Who cannot join
- Unable to receive chemotherapy
- Unstable vital sign
- Not suitable after evaluation by Principal Investigator
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital,Kaohsiung
Kaohsiung City, 833
Wan Hsiang Hu, +886-7-7317123 ext. 8008, gary.hu0805@gmail.com
About this study
We use clinical trial to explore the effect of nutrition support in colorectal cancer patients receiving postoperative adjuvant chemotherapy.
Read the detailed description
Colorectal cancer is the most common cancer in Taiwan. Side effects induced by postoperative adjuvant chemotherapy will affect nutrition status and may delay treatment and affect prognosis. Sarcopenia may be noted in some patients and increase the toxicities of chemotherapy. The studies of intervention include nutrition consultant and treatment like protein, fish oil or Vitamin D supplement. Premium amino acids include multiple amino acids and organic Selenium and have effect in inhibition of tumor proliferation according to colorectal cancer cell and animal experiments.
- Conditions
- Colorectal Cancer
- Being tested
- Premium Amino Acids
- Keywords
- colorectal cancer, Chemotherapy, Nutrition, Sarcopenia
- Medical subject headings
- Colorectal Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premium Amino AcidsDietary supplement
after Chemotherapy ang surgery one pack of Premium Amino Acids in the morning and evening
| Study group | Role | What they receive |
|---|---|---|
| control group: chemotherapy | No intervention | No intervention |
| experimental group: chemotherapy and nutrition support | Experimental | Premium amino acids 1pc bid for 6 months Receives: Dietary Supplement: Premium Amino Acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adverse event
Evaluation of adverse event(Grade 1-4) between control group and experimental group before every chemotherapy(total 12 times)
Measured: 2 weeks after chemotherapy
1)Nutrition assessment
albumin level between two group before every chemotherapy(total 12 times)
Measured: 2 weeks after chemotherapy
2)Nutrition assessment
pre-albumin level between two group before every chemotherapy(total 12 times)
Measured: 2 weeks after chemotherapy
1)Sarcopenia assessment muscle power
1-1)Assessment with Grip strength(Kg)
Measured: At 1st cycle of chemotherapy (each cycle is 2 weeks).
1)Sarcopenia assessment muscle power
1-2)Assessment with Grip strength(Kg)
Measured: At 12th cycle of chemotherapy (each cycle is 2 weeks).
2)Sarcopenia assessment muscle power
2-1)Assessment with ASM/heigh2(Kg/m2)
Measured: At 1st cycle of chemotherapy (each cycle is 2 weeks).
2)Sarcopenia assessment muscle power
2-2)Assessment with ASM/heigh2(Kg/m2)
Measured: At 12st cycle of chemotherapy (each cycle is 2 weeks).
3)Sarcopenia assessment
3-1)Assessment with speed(m/s)
Measured: At 1st cycle of chemotherapy (each cycle is 2 weeks).
3)Sarcopenia assessment
3-2)Assessment with speed(m/s)
Measured: At 12th cycle of chemotherapy (each cycle is 2 weeks).
4)Sarcopenia assessment
4-1)Assessment with DXA(g/cm2)
Measured: At 1st cycle of chemotherapy (each cycle is 2 weeks).
4)Sarcopenia assessment
4-2)Assessment with DXA(g/cm2)
Measured: At 12th cycle of chemotherapy (each cycle is 2 weeks).
5)Sarcopenia assessment
5-1)Assessment with abdominal CT
Measured: At 6th cycle of chemotherapy (each cycle is 2 weeks).
5)Sarcopenia assessment
5-2)Assessment with abdominal CT
Measured: At 12th cycle of chemotherapy (each cycle is 2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start27 Jan 2021 (estimated)
- Primary completion22 Feb 2021 (estimated)
- Study completion22 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hanben Enterprise
- Responsible party
- Principal investigator, Wan-Hsiang Hu, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567459
- Sponsor's protocol ID
- 202000035A3
- Status last verified
- Jan 2021
- First submitted
- 26 Aug 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chiang CJ, Lo WC, Yang YW, You SL, Chen CJ, Lai MS. Incidence and survival of adult cancer patients in Taiwan, 2002-2012. J Formos Med Assoc. 2016 Dec;115(12):1076-1088. doi: 10.1016/j.jfma.2015.10.011. Epub 2016 Jan 16.
PubMed 26786251Andre T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, Bonetti A, Clingan P, Bridgewater J, Rivera F, de Gramont A. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009 Jul 1;27(19):3109-16. doi: 10.1200/JCO.2008.20.6771. Epub 2009 May 18.
PubMed 19451431Casadaban L, Rauscher G, Aklilu M, Villenes D, Freels S, Maker AV. Adjuvant chemotherapy is associated with improved survival in patients with stage II colon cancer. Cancer. 2016 Nov 15;122(21):3277-3287. doi: 10.1002/cncr.30181. Epub 2016 Jul 15.
PubMed 27417445Gelibter AJ, Caponnetto S, Urbano F, Emiliani A, Scagnoli S, Sirgiovanni G, Napoli VM, Cortesi E. Adjuvant chemotherapy in resected colon cancer: When, how and how long? Surg Oncol. 2019 Sep;30:100-107. doi: 10.1016/j.suronc.2019.06.003. Epub 2019 Jul 2.
PubMed 31500770Jung HW, Kim JW, Kim JY, Kim SW, Yang HK, Lee JW, Lee KW, Kim DW, Kang SB, Kim KI, Kim CH, Kim JH. Effect of muscle mass on toxicity and survival in patients with colon cancer undergoing adjuvant chemotherapy. Support Care Cancer. 2015 Mar;23(3):687-94. doi: 10.1007/s00520-014-2418-6. Epub 2014 Aug 28.
PubMed 25163434Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
PubMed 24461239Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372Bano G, Trevisan C, Carraro S, Solmi M, Luchini C, Stubbs B, Manzato E, Sergi G, Veronese N. Inflammation and sarcopenia: A systematic review and meta-analysis. Maturitas. 2017 Feb;96:10-15. doi: 10.1016/j.maturitas.2016.11.006. Epub 2016 Nov 13.
PubMed 28041587Lin JX, Lin JP, Xie JW, Wang JB, Lu J, Chen QY, Cao LL, Lin M, Tu R, Zheng CH, Huang CM, Li P. Prognostic Value and Association of Sarcopenia and Systemic Inflammation for Patients with Gastric Cancer Following Radical Gastrectomy. Oncologist. 2019 Nov;24(11):e1091-e1101. doi: 10.1634/theoncologist.2018-0651. Epub 2019 Mar 25.
PubMed 30910865Tessier AJ, Chevalier S. An Update on Protein, Leucine, Omega-3 Fatty Acids, and Vitamin D in the Prevention and Treatment of Sarcopenia and Functional Decline. Nutrients. 2018 Aug 16;10(8):1099. doi: 10.3390/nu10081099.
PubMed 30115829Mazzuca F, Roberto M, Arrivi G, Sarfati E, Schipilliti FM, Crimini E, Botticelli A, Di Girolamo M, Muscaritoli M, Marchetti P. Clinical Impact of Highly Purified, Whey Proteins in Patients Affected With Colorectal Cancer Undergoing Chemotherapy: Preliminary Results of a Placebo-Controlled Study. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419866920. doi: 10.1177/1534735419866920.
PubMed 31370717
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutrition for the Colorectal Cancer Patients Receiving Chemotherapy-randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04567459
- Acronym / sponsor ID
- 202000035A3
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, Chemotherapy, Nutrition, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Hanben Enterprise
- Study start
- 27 Jan 2021 (estimated)
- Primary completion
- 22 Feb 2021 (estimated)
- Study completion
- 22 Feb 2021 (estimated)
- First posted
- 28 Sep 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.
We use clinical trial to explore the effect of nutrition support in colorectal cancer patients receiving postoperative adjuvant chemotherapy.
Detailed description
Colorectal cancer is the most common cancer in Taiwan. Side effects induced by postoperative adjuvant chemotherapy will affect nutrition status and may delay treatment and affect prognosis. Sarcopenia may be noted in some patients and increase the toxicities of chemotherapy. The studies of intervention include nutrition consultant and treatment like protein, fish oil or Vitamin D supplement. Premium amino acids include multiple amino acids and organic Selenium and have effect in inhibition of tumor proliferation according to colorectal cancer cell and animal experiments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group: chemotherapy | No intervention | –No intervention |
| experimental group: chemotherapy and nutrition support | Experimental | Dietary Supplement: Premium Amino AcidsPremium amino acids 1pc bid for 6 months |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 20
- Radical operation for stage III and stage II with high risk colorectal cancer
- Agree to join the trial and sign the informed consent form
Key exclusion criteria (3 listed)
- Unable to receive chemotherapy
- Unstable vital sign
- Not suitable after evaluation by Principal Investigator
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 |
|---|---|---|
| Premium Amino Acidsafter Chemotherapy ang surgery one pack of Premium Amino Acids in the morning and evening | Dietary supplement | experimental group: chemotherapy and nutrition support |
Primary outcome
Assessment of adverse event
Time frame: 2 weeks after chemotherapy
Evaluation of adverse event(Grade 1-4) between control group and experimental group before every chemotherapy(total 12 times)
1)Nutrition assessment
Time frame: 2 weeks after chemotherapy
albumin level between two group before every chemotherapy(total 12 times)
2)Nutrition assessment
Time frame: 2 weeks after chemotherapy
pre-albumin level between two group before every chemotherapy(total 12 times)
1)Sarcopenia assessment muscle power
Time frame: At 1st cycle of chemotherapy (each cycle is 2 weeks).
1-1)Assessment with Grip strength(Kg)
1)Sarcopenia assessment muscle power
Time frame: At 12th cycle of chemotherapy (each cycle is 2 weeks).
1-2)Assessment with Grip strength(Kg)
2)Sarcopenia assessment muscle power
Time frame: At 1st cycle of chemotherapy (each cycle is 2 weeks).
2-1)Assessment with ASM/heigh2(Kg/m2)
2)Sarcopenia assessment muscle power
Time frame: At 12st cycle of chemotherapy (each cycle is 2 weeks).
2-2)Assessment with ASM/heigh2(Kg/m2)
3)Sarcopenia assessment
Time frame: At 1st cycle of chemotherapy (each cycle is 2 weeks).
3-1)Assessment with speed(m/s)
3)Sarcopenia assessment
Time frame: At 12th cycle of chemotherapy (each cycle is 2 weeks).
3-2)Assessment with speed(m/s)
4)Sarcopenia assessment
Time frame: At 1st cycle of chemotherapy (each cycle is 2 weeks).
4-1)Assessment with DXA(g/cm2)
4)Sarcopenia assessment
Time frame: At 12th cycle of chemotherapy (each cycle is 2 weeks).
4-2)Assessment with DXA(g/cm2)
5)Sarcopenia assessment
Time frame: At 6th cycle of chemotherapy (each cycle is 2 weeks).
5-1)Assessment with abdominal CT
5)Sarcopenia assessment
Time frame: At 12th cycle of chemotherapy (each cycle is 2 weeks).
5-2)Assessment with abdominal CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Background: PubMed 26786251Chiang CJ, Lo WC, Yang YW, You SL, Chen CJ, Lai MS. Incidence and survival of adult cancer patients in Taiwan, 2002-2012. J Formos Med Assoc. 2016 Dec;115(12):1076-1088. doi: 10.1016/j.jfma.2015.10.011. Epub 2016 Jan 16.
- Background: PubMed 19451431Andre T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, Bonetti A, Clingan P, Bridgewater J, Rivera F, de Gramont A. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009 Jul 1;27(19):3109-16. doi: 10.1200/JCO.2008.20.6771. Epub 2009 May 18.
- Background: PubMed 27417445Casadaban L, Rauscher G, Aklilu M, Villenes D, Freels S, Maker AV. Adjuvant chemotherapy is associated with improved survival in patients with stage II colon cancer. Cancer. 2016 Nov 15;122(21):3277-3287. doi: 10.1002/cncr.30181. Epub 2016 Jul 15.
- Background: PubMed 31500770Gelibter AJ, Caponnetto S, Urbano F, Emiliani A, Scagnoli S, Sirgiovanni G, Napoli VM, Cortesi E. Adjuvant chemotherapy in resected colon cancer: When, how and how long? Surg Oncol. 2019 Sep;30:100-107. doi: 10.1016/j.suronc.2019.06.003. Epub 2019 Jul 2.
- Background: PubMed 25163434Jung HW, Kim JW, Kim JY, Kim SW, Yang HK, Lee JW, Lee KW, Kim DW, Kang SB, Kim KI, Kim CH, Kim JH. Effect of muscle mass on toxicity and survival in patients with colon cancer undergoing adjuvant chemotherapy. Support Care Cancer. 2015 Mar;23(3):687-94. doi: 10.1007/s00520-014-2418-6. Epub 2014 Aug 28.
- Background: PubMed 24461239Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
- Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Background: PubMed 28041587Bano G, Trevisan C, Carraro S, Solmi M, Luchini C, Stubbs B, Manzato E, Sergi G, Veronese N. Inflammation and sarcopenia: A systematic review and meta-analysis. Maturitas. 2017 Feb;96:10-15. doi: 10.1016/j.maturitas.2016.11.006. Epub 2016 Nov 13.
- Background: PubMed 30910865Lin JX, Lin JP, Xie JW, Wang JB, Lu J, Chen QY, Cao LL, Lin M, Tu R, Zheng CH, Huang CM, Li P. Prognostic Value and Association of Sarcopenia and Systemic Inflammation for Patients with Gastric Cancer Following Radical Gastrectomy. Oncologist. 2019 Nov;24(11):e1091-e1101. doi: 10.1634/theoncologist.2018-0651. Epub 2019 Mar 25.
- Background: PubMed 30115829Tessier AJ, Chevalier S. An Update on Protein, Leucine, Omega-3 Fatty Acids, and Vitamin D in the Prevention and Treatment of Sarcopenia and Functional Decline. Nutrients. 2018 Aug 16;10(8):1099. doi: 10.3390/nu10081099.
- Background: PubMed 31370717Mazzuca F, Roberto M, Arrivi G, Sarfati E, Schipilliti FM, Crimini E, Botticelli A, Di Girolamo M, Muscaritoli M, Marchetti P. Clinical Impact of Highly Purified, Whey Proteins in Patients Affected With Colorectal Cancer Undergoing Chemotherapy: Preliminary Results of a Placebo-Controlled Study. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419866920. doi: 10.1177/1534735419866920.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Premium Amino Acids in people with Colorectal Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jan 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan-Hsiang Hu, M.D. (886-975056227, gary.hu0805@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of adverse event (time frame: 2 weeks after chemotherapy). The study lists 13 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 NCT04567459, which also lists 11 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 28 Jan 2021.