UMIN-ICDS Clinical Trial

Public title

Predictors and Predictive Models of Radiation Therapy Side Effects in Head and Neck Cancer: A Scoping Review.

Acronym

Predictors and Predictive Models of Radiation Therapy Side Effects in Head and Neck Cancer: A Scoping Review.

Scientific Title

Predictors and Predictive Models of Radiation Therapy Side Effects in Head and Neck Cancer: A Scoping Review.

Scientific Title:Acronym

Predictors and Predictive Models of Radiation Therapy Side Effects in Head and Neck Cancer: A Scoping Review.

Region

Japan

Condition

Head and Neck Cancer

Classification by specialty

Oto-rhino-laryngology	Oral surgery	Nursing

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To identify the risk factors and predictive models for side effects of radiation therapy for head and neck cancer.

Basic objectives2

Others

Basic objectives -Others

To determine the accuracy of a predictive model for the side effects of radiation therapy for head and neck cancer.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The side effects of radiation therapy for head and neck cancer.

Key secondary outcomes

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Head and neck cancer patients undergoing radiation therapy
2. Studies that predict symptoms (by constructing predictive models or identifying predictive factors)
3. The research designs to be adopted are as follows:
(1) Observational studies (prospective and retrospective cohort studies, cross-sectional studies)
(2) Intervention studies (including RCTs and non-randomized controlled trials), as well as secondary analyses

Key exclusion criteria

1. Esophageal cancer, brain tumors, skin cancer and malignant lymphoma of the head and neck region
2. Surgery alone or anticancer drug therapy alone
3. Studies limited to descriptive statistics or univariate analysis
4. Studies with survival rates or tumor reduction as the primary outcomes
5. Qualitative studies, case series, case reports, review articles, conference abstracts, research protocols, letters, and commentaries

Target sample size

Name of lead principal investigator

1st name	Sawaguchi
Middle name
Last name	Hiroto

Organization

Mie University

Division name

Graduate School of Medicine

Zip code

514-8507

Address

2-174 Edobashi, Tsu

TEL

059-232-1211

Email

326d104@m.mie-u.ac.jp

Name of contact person

1st name	Sawaguchi
Middle name
Last name	Hiroto

Organization

Mie University

Division name

Graduate School of Medicine

Zip code

514-8507

Address

2-174 Edobashi, Tsu

TEL

059-232-1211

Homepage URL

Email

326d104@m.mie-u.ac.jp

Institute

Mie University

Institute

Department

Personal name

Hiroto Sawaguchi

Organization

JSPS KAKENHI Grant

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Mie University

Address

2-174 Edobashi, Tsu

Tel

059-232-1211

Email

326d104@m.mie-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

05

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

05

Month

15

Day

Date of IRB

Anticipated trial start date

2026

Year

05

Month

15

Day

Last follow-up date

2027

Year

05

Month

15

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. Data sources and strategy
We will conduct a scoping review to identify predictive factors and predictive models for the side effects of radiation therapy for head and neck cancer. This scoping review will be conducted using the electronic databases, PubMed, CINAHL, PsycInfo, the Cochrane Library, and Ichushi Web version 5. The search will use keywords related to "head and neck cancer," "symptoms," and "prediction" across all literature to identify studies published between January 1, 2010, and May 15, 2026.
2. Selection of studies in the included studies
Two review authors will independently assess whether studies meet the inclusion criteria. Any discrepancies in study selection will be resolved through discussion with a third author.

Registered date

2026

Year

05

Month

22

Day

Last modified on

2026

Year

05

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070556