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Non Small Cell Lung CancerPhase 3ReliefNCT06840704

Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer

A Phase 3 study testing Oral immunonutrition in people with Non Small Cell Lung Cancer and Small Cell Lung Cancer, run by Hunan Cancer Hospital at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to evaluate the efficacy of immunonutrition in reducing acute esophagitis after thoracic radiotherapy in lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oral immunonutrition
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
6 sitesChina
Study dates
25 Feb 2025to 30 Dec 2026
Phase
Phase 3
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject voluntarily participates in this clinical study, understands the study procedures, and is able to provide written informed consent.
  • Age ≥ 18 years.
  • Pathologically confirmed diagnosis of lung cancer, including non-small cell lung cancer and small cell lung cancer.
  • Indication for thoracic radiotherapy, with the esophagus within 1 cm of the PTV.
  • Prescription dose for the PTV: 60-70 Gy once daily (2 Gy/Fx), 45 Gy twice daily (1.5 Gy/Fx, with intervals exceeding 6 hours), or 45 Gy once daily (3 Gy/Fx).
  • Ability to orally intake food normally.
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  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
  • The volume of both lungs receiving more than 20 Gy (V20) should not exceed 30% of the total lung volume.
  • Expected survival of more than 3 months.
  • Laboratory test results during the screening period:
  • Complete blood count: ANC ≥ 1.5 × 10^9/L; PLT ≥ 80 × 10^9/L; Hb ≥ 90 g/L. Blood biochemistry: TBIL ≤ 1.5 × ULN; ALT and AST ≤ 2 × ULN; BUN and Cr ≤ 1.5 × ULN, with creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula).
  • Female subjects of childbearing potential, male subjects, and partners of male subjects agree to use reliable contraceptive methods during the study period (such as abstinence, sterilization, oral contraceptives, or other contraceptive measures).

Who cannot join

  • Previous history of thoracic radiotherapy.
  • Suspected or confirmed tumor invasion of the esophagus.
  • Patients with other primary tumors.
  • History of esophageal cancer, gastric cancer, or prior esophageal surgery.
  • Concurrent active reflux esophagitis.
  • Current regular use of immunonutrition (e.g., Oral Impact®).
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  • Patients with severe cardiovascular or cerebrovascular diseases, or comorbidities such as liver or kidney diseases.
  • Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
  • Concurrent active autoimmune diseases requiring treatment.
  • Known history of human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS).
  • Any medical (e.g., pulmonary, metabolic, endocrine, or neurological diseases, congenital disorders, etc.), psychiatric, or social condition that, in the investigator's judgment, may interfere with the subject's rights, safety, health, or ability to provide informed consent, cooperate and participate in the study, or interfere with the evaluation of the study drug, interpretation of patient safety, or study results.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Huai Liu, M.D. contact

+8673189762230

liuhuai@hnca.org.cn

6 sites in 1 country

China6 sites, 6 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Huai Liu, M.D., +8673189762230, liuhuai@hnca.org.cn

    Recruiting

  • Third Xiangya Hospital, Central South University

    Changsha, Hunan, 410013

    Xuewen Liu, +8618711033808, aveinliu@163.com

    Recruiting

  • Xiangya Hospital of Central South University,

    Changsha, Hunan

    Rongrong Zhou, +8613875898127, zhourr@csu.edu.cn

    Recruiting

  • The First People's Hospital of Chenzhou

    Chenzhou, Hunan

    Qiyuan Zhou, 8618175547107, czyyflgcp@163.com

    Recruiting

  • The Fisrt Affilated Hospital of University of South China

    Hengyang, Hunan, 421001

    Yuehua Li, +8618216037899, liyuehua2020@stu.usc.edu.cn

    Recruiting

  • Yueyang Central Hospital

    Yueyang, Hunan

    Jie Weng, 8613975070672, 3173720582@qq.com

    Recruiting

Other trials in China

About this study

Official title: Immunonutrition in Reducing Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer: a Prospective, Randomized, Controlled, Open-label Clinical Trial

This study aims to evaluate the efficacy of immunonutrition in reducing acute esophagitis after thoracic radiotherapy in lung cancer.

Read the detailed description

This is a prospective, randomized, controlled, open-label clinical trial, which aimed to explore the efficacy and safety of oral immunonutrition therapy in reducing acute esophagitis after thoracic radiotherapy in lung cancer patients.

Being tested
Oral immunonutrition
Keywords
non-small cell lung cancer, small cell lung cancer, esophagitis, immunonutrition, radiotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Esophagitis

What participants receive

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

  • Oral immunonutritionDietary supplement

    Oral immunonutrition (Oral Impact®, Nestlé), 250 ml per bottle, with a dosage of 2 bottles per day, starting on the day of radiotherapy and continuing for three weeks after radiotherapy.

Study groups in NCT06840704
Study groupRoleWhat they receive
Oral immunonutritionExperimentalOral immunonutrition (Oral Impact®, Nestlé), 250 ml per bottle, with a dosage of 2 bottles per day, starting on the day of radiotherapy and continuing for three weeks after radiotherapy.
Receives: Dietary Supplement: Oral immunonutrition
Standard nutritionNo interventionIf the patient has concurrent nutritional risks, routine nutritional therapy (no immunonutrition) can be provided under the guidance of a nutritionist.

What is being measured

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

  1. Incidence rate of grade 2 or higher acute esophagitis

    Assessed according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

    Measured: 3 months

Secondary outcomes (11)

  1. Incidence rate of grade 2 or higher acute esophagitis

    Assessed according to RTOG toxicity criteria.

    Measured: 3 months

  2. Incidence rate of grade 3 or higher acute esophagitis assessed according to NCI-CTCAE v5.0 criteria

    Assessed according to NCI-CTCAE v5.0 criteria

    Measured: 3 months

  3. Incidence rate of grade 3 or higher acute esophagitis assessed according to RTOG toxicity criteria

    Assessed according to RTOG toxicity criteria

    Measured: 3 months

  4. Nutritional Assessment according to the Patient-Generated Subjective Global Assessment（PG-SGA）

    PG-SGA scores range from 0 to 35, with higher scores indicating a greater risk of severe malnutrition.

    Measured: 3 months

  5. Body weight

    Measured: 3 months

  6. Nutritional Risk

    Assessed according to Nutritional Risk Screening 2002 (NRS 2002)

    Measured: 3 months

  7. The duration period of esophagitis

    The number of days of grade 2 or higher esophagitis

    Measured: 3 months

  8. Opioid use

    Measured by documented opioid use

    Measured: 3 months

  9. Quality of life assessed by EORTC QLQ-C30

    EORTC QLQ-C30 scores range from 0 to 100, with higher scores indicating a better quality of life.

    Measured: 3 months

  10. Quality of life assessed by FACT-L

    FACT-L scores range from 0 to 108, with higher scores indicating a better quality of life.

    Measured: 3 months

  11. Quality of life assessed by FACT-E Eating and Swallowing Subscales

    FACT-E Eating and Swallowing Subscales scores range from 0 to 68, with higher scores indicating a better quality of life.

    Measured: 3 months

Timeline

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

  1. First posted21 Feb 2025
  2. Study start25 Feb 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06840704
Sponsor's protocol ID
IIT128
Acronym
Relief
Status last verified
Mar 2026
First submitted
8 Feb 2025
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Hospital policy

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oral immunonutrition in people with Non Small Cell Lung Cancer and Small Cell Lung Cancer, run by Hunan Cancer Hospital at 6 sites 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 12 inclusion and 11 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 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

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 Huai Liu, M.D. (+8673189762230, liuhuai@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of grade 2 or higher acute esophagitis (time frame: 3 months). 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 NCT06840704.

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 2 Apr 2026.

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