NCT05059613

Brief Summary

Study on the application of thalidomide with or without probiotics in radioactive oral mucositis

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

August 31, 2021

Last Update Submit

September 19, 2021

Conditions

Oral MucositisQuality of Life

Outcome Measures

Primary Outcomes (4)

  • the incidence of Radiation Therapy Oncology Group grade 3 mucositis

    Radiation oral mucositis

    one month

  • the variaty of immune index

    CD3,CD4,CD8

    one month

  • the variaty of immune index

    Hemoglobin

    one month

  • the variaty of immune index

    lymphocyte ratio

    one month

Study Arms (3)

probiotics group

EXPERIMENTAL

Use thalidomide in combination with probiotics during radiotherapy and chemotherapy

Other: probiotics

thalidomide group

NO INTERVENTION

Thalidomide is used only during radiotherapy and chemotherapy

healthy control group

NO INTERVENTION

healthy control group

Interventions

probioticsOTHER

one times a day during the whole treatment

probiotics group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Karnofsky score ≥80 ,newly diagnosed NPC without distant metastasis, confirmed by pathology without any other malignant disease history ,no any other anti-cancer treatment for NPC previously ,received radiotherapy and chemotherapy at our Cancer Center

You may not qualify if:

  • any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location

MeSH Terms

Conditions

Stomatitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Chunling Jiang, MD PHD

    Jiangxi Provincial Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunling Jiang, MD PHD

CONTACT

13979109200jclil2002@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 28, 2021

Study Start

September 20, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations

CN(1)