An Analysis of the Relative Risk for Low Triiodothyronine Syndrome in Patients With Chronic Radiation Enteritis

NCT ID: NCT02452073

Last Updated: 2015-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Radiation enteritis (RE) is by simple definition an inflammatory process occurring at the level of the intestines as a response to abdominal or pelvic radiation energy exposure. Due to the dosage of radiation, sensitivity of organs to radiation, and some patient characteristics, RE can present as either an acute or chronic syndrome. Clinical manifestations differ but may include abdominal pain, malabsorption, diarrhea, cachexia, intestinal bleeding, obstruction, and even perforation, which compromise quality of life. For many years, radiotherapy of the abdominal or pelvic region is commonly used for a significant percentage of patients with rectosigmoid and genitourinary system tumors. Different techniques have been developed to prevent the occurrence of radiation induced injury. However, the incidence of CRE is expected to continue to rise during the coming years. What's more, abdominal or pelvic radiotherapy can also lead to other side effects in addition to RE, such as skin desquamation, local soft tissue injury, and so on. Till now, lots of attention is only paid to local complications, there is little report on systemic damage of abdominal or pelvic radiotherapy.

Low triiodothyronine syndrome (LT3S), a condition characterized by low circulating triiodothyronine (T3) levels, normal thyroxine (T4), free thyroxine (FT4) and thyroid-stimulating hormone (TSH) levels in the absence of an intrinsic thyroid disease, is variously known as the "nonthyroidal illness syndrome (NTIS)". This condition is frequently detected in critical illness. Reichlin et al. first noticed that some aspects of thyroid hormone metabolism might change during many chronic illnesses as early as 1973. Data has shown that about 35-70% of acute and chronic critical conditions were associated with a significant abnormal thyroid hormone metabolism, of which LT3S was the most common type. Furthermore, these changes have been shown to be associated with disease severity and have been connected with poor short-term prognosis.

To date, there are lots of literatures include detailed reports on the relationship between LT3S and chronic illnesses such as rheumatoid arthritis, systemic lupus erythematosus, sepsis, and so on. However, no systematic analysis of LT3S in patients with CRE has been undertaken. As such, the present study aimed to investigate the frequency of LT3S in CRE patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

The Clinical Incidence of Low Triiodothyronine Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CRE group

patients with chronic radiation enteritis

Thyroid function tests

Intervention Type OTHER

malignancy group

patients with some kinds of malignant tumors but had not previously received radiotherapy

Thyroid function tests

Intervention Type OTHER

control group

age-matched healthy volunteers

Thyroid function tests

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thyroid function tests

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with chronic radiation enteritis
* patients with some kinds of malignant tumors but had not previously received radiotherapy
* age-matched healthy volunteers

Exclusion Criteria

* Patients with a chronic disease other than CRE, including RA, SLE, thyroid illness, infectious diseases, and hepatic or renal disorders were excluded.
* patients have taken any drugs that may influence thyroid hormone secretion and metabolism during the previous 3 months.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shengxian Fan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shengxian Fan

M.D.

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JinlingH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hyperthyroid Follow-Up Study
NCT02989103 COMPLETED