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AzTrials

Local Advanced Non-small Cell Lung CancerPhase 2NCT03673657

Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer

A Phase 2 study testing Early Nutrition Intervention from the start of CCRT, Thoracic radiotherapy and Weekly DP chemotherapy concurrent with thoracic radiotherapy in people with Local Advanced Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This single-arm phase II prospective study is to determine the efficacy of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Early Nutrition Intervention from the start of CCRT, Thoracic radiotherapy and Weekly DP chemotherapy concurrent with thoracic radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteChina
Study dates
10 Aug 2018to 31 Aug 2023
Phase
Phase 2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed unresectable stage IIIA-IIIC non-small cell lung cancer.
  • Recieved definitive concurrent chemoradiotherapy.
  • Pretreatment PG-SGA score A or B.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Estimated life expectancy of at least 6 months.
  • Without contraindication for chemoradiotherapy.

Who cannot join

  • Severe impairment of intestinal function, or intolerance of enteral nutrition.
  • Severe vomiting, gastrointestinal bleeding, or intestinal obstruction.
  • Severe malnutrition, or intolerance of chemoradiotherapy.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: A Prospective, Single-arm, Phase II Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer

This single-arm phase II prospective study is to determine the efficacy of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer.

Read the detailed description

This single-arm phase II prospective study is to determine the efficacy of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer.

Patients in the study group received early nutritional intervention, including individualized nutrition counseling and oral nutritional supplements from the initiation of CCRT to 2 weeks after its completion. Weekly counseling sessions, conducted by both doctors and nurses, aimed to educate patients on regulating their regular dietary intake to meet specific energy, protein, and other macronutrient requirements. Dietary advice provided precise instructions on food type and quantity, meal frequency, and calorie or protein intake to ensure a daily energy intake of approximately 30 kcal/kg. All patients received definitive thoracic radiotherapy with total radiation doses of 60-68 Gy, concurrent with weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡).

Being tested
Early Nutrition Intervention from the start of CCRT, Thoracic radiotherapy, Weekly DP chemotherapy concurrent with thoracic radiotherapy
Keywords
Local Advanced Non-small Cell Lung Cancer, Chemoradiotherapy, Early nutritional intervention

What participants receive

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

  • Early Nutrition Intervention from the start of CCRTDietary supplement

    Nutrition counseling and oral nutritional supplements from the start of radiotherapy; weekly counseling sessions; daily energy intake of approximately 30 kcal/kg.

  • Thoracic radiotherapyRadiation

    Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy

  • Weekly DP chemotherapy concurrent with thoracic radiotherapyDrug

    Weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡) concurrent with thoracic radiotherapy

Study groups in NCT03673657
Study groupRoleWhat they receive
The study groupExperimentalPatients in the study group received early nutritional intervention, including individualized nutrition counseling and oral nutritional supplements from the initiation of CCRT to 2 weeks after its completion. Energy goal: daily total nutritional intake of about 30 kcal/kg. Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy; Weekly DP chemotherapy concurrent with thoracic radiotherapy.
Receives: Dietary Supplement: Early Nutrition Intervention from the start of CCRT; Radiation: Thoracic radiotherapy; Drug: Weekly DP chemotherapy concurrent with thoracic radiotherapy

What is being measured

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

  1. The incidence of weight loss ≥5% during the treatment

    The proportion of patients experiencing a weight loss of 5% or more during the CCRT

    Measured: From the start to the end of CCRT

Secondary outcomes (5)

  1. Nutrition-related parameters

    Nutrition-related parameters, including weight, body mass index (BMI), hemoglobin (HGB), serum albumin (ALB), pre-albumin (PA), lymphocyte (LY)

    Measured: up to 6 months after radiotherapy

  2. EORTC Quality of Life Questionnaire C30 (QLQ-C30)

    Quality of Life

    Measured: up to 6 months after radiotherapy

  3. Scored Patient-Generated Subjective Global Assessment

    PG-SGA scores and grades

    Measured: up to 6 months after radiotherapy

  4. Toxicities

    Treatment-related toxicities, including hematologic adverse effects, radiation pneumonitis, and radiation esophagitis.

    Measured: up to 1 year after radiotherapy

  5. Survival outcomes

    Including overall survival and progression-free survival.

    Measured: 3 years

Timeline

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

  1. First posted17 Sep 2018
  2. Study start10 Aug 2018
  3. Primary completion16 Mar 2020
  4. Study completion31 Aug 2023

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03673657
Sponsor's protocol ID
GASTO-1041
Status last verified
Dec 2023
First submitted
5 Sep 2018
Last updated
8 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bovio G, Montagna G, Bariani C, Baiardi P. Upper gastrointestinal symptoms in patients with advanced cancer: relationship to nutritional and performance status. Support Care Cancer. 2009 Oct;17(10):1317-24. doi: 10.1007/s00520-009-0590-x. Epub 2009 Feb 8.

    PubMed 19199106

  • Kiss N, Isenring E, Gough K, Krishnasamy M. The prevalence of weight loss during (chemo)radiotherapy treatment for lung cancer and associated patient- and treatment-related factors. Clin Nutr. 2014 Dec;33(6):1074-80. doi: 10.1016/j.clnu.2013.11.013. Epub 2013 Nov 25.

    PubMed 24325888

  • Unsal D, Mentes B, Akmansu M, Uner A, Oguz M, Pak Y. Evaluation of nutritional status in cancer patients receiving radiotherapy: a prospective study. Am J Clin Oncol. 2006 Apr;29(2):183-8. doi: 10.1097/01.coc.0000198745.94757.ee.

    PubMed 16601440

  • Luo J, Chen YJ, Narsavage GL, Ducatman A. Predictors of survival in patients with non-small cell lung cancer. Oncol Nurs Forum. 2012 Nov;39(6):609-16. doi: 10.1188/12.ONF.609-616.

    PubMed 23107855

  • Sanchez-Lara K, Turcott JG, Juarez E, Guevara P, Nunez-Valencia C, Onate-Ocana LF, Flores D, Arrieta O. Association of nutrition parameters including bioelectrical impedance and systemic inflammatory response with quality of life and prognosis in patients with advanced non-small-cell lung cancer: a prospective study. Nutr Cancer. 2012;64(4):526-34. doi: 10.1080/01635581.2012.668744. Epub 2012 Apr 10.

    PubMed 22489794

  • Ma L, Ye W, Li Q, Wang B, Luo G, Chen Z, Guo S, Qiu B, Liu H. Subjective Global Assessment (SGA) Score Could Be a Predictive Factor for Radiation Pneumonitis in Lung Cancer Patients With Normal Pulmonary Function Treated by Intensity-Modulated Radiation Therapy and Concurrent Chemotherapy. Clin Lung Cancer. 2018 Mar;19(2):e211-e217. doi: 10.1016/j.cllc.2017.09.001. Epub 2017 Sep 19.

    PubMed 29017827

  • Isenring EA, Capra S, Bauer JD. Nutrition intervention is beneficial in oncology outpatients receiving radiotherapy to the gastrointestinal or head and neck area. Br J Cancer. 2004 Aug 2;91(3):447-52. doi: 10.1038/sj.bjc.6601962.

    PubMed 15226773

  • Ravasco P, Monteiro-Grillo I, Marques Vidal P, Camilo ME. Impact of nutrition on outcome: a prospective randomized controlled trial in patients with head and neck cancer undergoing radiotherapy. Head Neck. 2005 Aug;27(8):659-68. doi: 10.1002/hed.20221.

    PubMed 15920748

  • Ravasco P, Monteiro-Grillo I, Vidal PM, Camilo ME. Dietary counseling improves patient outcomes: a prospective, randomized, controlled trial in colorectal cancer patients undergoing radiotherapy. J Clin Oncol. 2005 Mar 1;23(7):1431-8. doi: 10.1200/JCO.2005.02.054. Epub 2005 Jan 31.

    PubMed 15684319

  • Kiss NK, Krishnasamy M, Isenring EA. The effect of nutrition intervention in lung cancer patients undergoing chemotherapy and/or radiotherapy: a systematic review. Nutr Cancer. 2014;66(1):47-56. doi: 10.1080/01635581.2014.847966. Epub 2013 Dec 9.

    PubMed 24320097

  • Sanders KJ, Hendriks LE, Troost EG, Bootsma GP, Houben RM, Schols AM, Dingemans AM. Early Weight Loss during Chemoradiotherapy Has a Detrimental Impact on Outcome in NSCLC. J Thorac Oncol. 2016 Jun;11(6):873-9. doi: 10.1016/j.jtho.2016.02.013. Epub 2016 Mar 3.

    PubMed 26940529

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Early Nutrition Intervention from the start of CCRT, Thoracic radiotherapy and Weekly DP chemotherapy concurrent with thoracic radiotherapy in people with Local Advanced Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.

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 6 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: finished, as of the sponsor's last update on 8 Dec 2023. 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 China. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The incidence of weight loss ≥5% during the treatment (time frame: From the start to the end of CCRT). 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 NCT03673657, 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 8 Dec 2023.

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