Pre-Radiotherapy n-6/n-3 Fatty Acid Ratio Predicts Severe Oral Mucositis in Nasopharyngeal Carcinoma
NCT07920250, Phase 2, Completed, Affiliated Hospital of Guangdong Medical University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Pre-Radiotherapy n-6/n-3 Fatty Acid Ratio Predicts Severe Oral Mucositis in Nasopharyngeal Carcinoma | ClinicalTrials.gov |
| NCT number | NCT07920250 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 210 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Affiliated Hospital of Guangdong Medical University | ClinicalTrials.gov |
| Conditions | Nasopharyngeal Carcinoma (NPC), Radiation-induced Oral Mucositis, Head and Neck Neoplasms | ClinicalTrials.gov |
| Interventions | Toripalimab (240mg day1, Q3W*3cycle), Cisplatin (80 mg/m2), Nab-paclitaxel, Intensity-Modulated Radiotherapy (IMRT) | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Longitudinal change in erythrocyte membrane n-6/n-3 fatty acid ratio. | Baseline (within 1 week before treatment) to 1 month after radiotherapy (T7). | Change in erythrocyte membrane n-6/n-3 polyunsaturated fatty acid (PUFA) ratio from baseline to 1 month after radiotherapy. | ClinicalTrials.gov |
| Primary | Longitudinal change in erythrocyte membrane ALA level. | Baseline (within 1 week before treatment) to 1 month after radiotherapy (T7). | Change in erythrocyte membrane alpha-linolenic acid (ALA) level from baseline to 1 month after radiotherapy. | ClinicalTrials.gov |
| Primary | Longitudinal change in erythrocyte membrane EPA level. | Baseline (within 1 week before treatment) to 1 month after radiotherapy (T7). | Change in erythrocyte membrane eicosapentaenoic acid (EPA) level from baseline to 1 month after radiotherapy. | ClinicalTrials.gov |
| Primary | Longitudinal change in erythrocyte membrane DHA level. | Baseline (within 1 week before treatment) to 1 month after radiotherapy (T7). | Change in erythrocyte membrane docosahexaenoic acid (DHA) level from baseline to 1 month after radiotherapy. | ClinicalTrials.gov |
| Primary | Longitudinal change in erythrocyte membrane LA level. | Baseline (within 1 week before treatment) to 1 month after radiotherapy (T7). | Change in erythrocyte membrane linolenic acid (LA) level from baseline to 1 month after radiotherapy. | ClinicalTrials.gov |
| Primary | Longitudinal change in erythrocyte membrane AA level. | Baseline (within 1 week before treatment) to 1 month after radiotherapy (T7). | Change in erythrocyte membrane arachidonic acid (AA) level from baseline to 1 month after radiotherapy. | ClinicalTrials.gov |
| Primary | Longitudinal change in erythrocyte membrane DTA level. | Baseline (within 1 week before treatment) to 1 month after radiotherapy (T7). | Change in erythrocyte membrane docosatetraenoic acid (DTA) level from baseline to 1 month after radiotherapy. | ClinicalTrials.gov |
| Secondary | Dynamic Changes in IL-4 | Baseline (T0) to 1 month after radiotherapy (T7). | Changes in plasma levels of interleukin-4 (IL-4) during treatment. | ClinicalTrials.gov |
| Secondary | Dynamic Changes in IL-6 | Baseline (T0) to 1 month after radiotherapy (T7). | Changes in plasma levels of interleukin-6 (IL-6) during treatment. | ClinicalTrials.gov |
| Secondary | Dynamic Changes in IL-10 | Baseline (T0) to 1 month after radiotherapy (T7). | Changes in plasma levels of interleukin-10 (IL-10) during treatment. | ClinicalTrials.gov |
| Secondary | Dynamic Changes in IL-12p70 | Baseline (T0) to 1 month after radiotherapy (T7). | Changes in plasma levels of interleukin-12p70 (IL-12p70) during treatment. | ClinicalTrials.gov |
| Secondary | Dynamic Changes in IL-17 | Baseline (T0) to 1 month after radiotherapy (T7). | Changes in plasma levels of interleukin-17 (IL-17) during treatment. | ClinicalTrials.gov |
| Secondary | Dynamic Changes in IFN-γ | Baseline (T0) to 1 month after radiotherapy (T7). | Changes in plasma levels of interferon-gamma (IFN-γ) during treatment. | ClinicalTrials.gov |
| Secondary | Dynamic Changes in TNF-α | Baseline (T0) to 1 month after radiotherapy (T7). | Changes in plasma levels of tumor necrosis factor-alpha (TNF-α) during treatment. | ClinicalTrials.gov |
| Other | Incidence, Severity, and Timing of Treatment-Related Adverse Events | From start of treatment to 1 month after radiotherapy (T7). | Incidence, severity (CTCAE v5.0), and timing of all treatment-related adverse events, with particular attention to radiation-induced oral mucositis (RIOM). | ClinicalTrials.gov |
| Other | Correlation Between Severe RIOM and Erythrocyte Fatty Acid Profile or Cytokine Levels | Pre-radiotherapy (T4) and mid-radiotherapy (T5, 40 Gy). | Correlation between grade ≥3 radiation-induced oral mucositis and erythrocyte membrane fatty acid parameters or plasma cytokine levels at key time points. | ClinicalTrials.gov |
| Other | Dynamic Changes in Body Weight | Baseline (T0) to 1 month after radiotherapy (T7). | Changes in body weight (kg) during treatment. | ClinicalTrials.gov |
| Other | Dynamic changes in Patient-Generated Subjective Global Assessment (PG-SGA) classification | Baseline (T0) to 1 month after radiotherapy (T7). | Change in nutritional status classification assessed by the Patient-Generated Subjective Global Assessment (PG-SGA) from baseline to 1 month after radiotherapy. Nutritional status is classified into three categories: Stage A (well-nourished), Stage B (moderate or suspected malnutrition), and Stage C (severe malnutrition). | ClinicalTrials.gov |
| Other | Predictive Value of Pre-Radiotherapy n-6/n-3 Ratio for Grade ≥3 RIOM | From the pre-radiotherapy assessment (T4) until the first documented occurrence of grade ≥3 RIOM or completion of the 1-month post-radiotherapy follow-up (T7), whichever came first, assessed up to a maximum of 12 weeks. | Predictive performance of pre-radiotherapy erythrocyte membrane n-6/n-3 fatty acid ratio for grade ≥3 radiation-induced oral mucositis, including odds ratio, area under the ROC curve, sensitivity, specificity, and negative predictive value. | ClinicalTrials.gov |
| Other | Dynamic Changes in BMI | Baseline (T0) to 1 month after radiotherapy (T7). | Changes in body mass index (BMI, kg/m²) during treatment. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)