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Clinical Trials/CTRI/2024/06/069291
CTRI/2024/06/069291
Not yet recruiting
Phase 4

A randomized clinical trial to assess the effectiveness of post operative swallowing exercises and nutritional intervention in patients undergoing Head and Neck Cancer treatment at a tertiary care center

Doppalapudi Radhika1 site in 1 country80 target enrollmentStarted: July 29, 2024Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Doppalapudi Radhika
Enrollment
80
Locations
1
Primary Endpoint
Improvement in mouth opening

Overview

Brief Summary

PhD THESIS with the title of A Randomized clinical trial to assess the effectiveness of swallowing exercises and nutritional intervention in patients undergoing head and neck cancer treatment at a tertiary care center

Swallowing exercises are to be performed by the head and neck cancer patients as demonstrated and the improvement in mouth opening are noted. Nutritional health education is provided by the nutritionist and height, weight, body mass index before and after the treatment is noted. The EORCTC head and neck cancer questionnaire will be distributed to these patients and the responses on quality of life of these patients will be recorded.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
30.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • head and neck cancer patients treated at a tertiary care center.

Exclusion Criteria

  • patients who have undergone glossectomy as a part of the treatment for head and neck cancer patients who are not willing to participate in the study.

Outcomes

Primary Outcomes

Improvement in mouth opening

Time Frame: 6 months | 12 months

Body mass Index

Time Frame: 6 months | 12 months

Secondary Outcomes

  • Quality of life assessment using EORCTC Head & Neck questionnaire(6 months & 12 months)

Investigators

Sponsor
Doppalapudi Radhika
Sponsor Class
Other [self sponsor]
Responsible Party
Principal Investigator
Principal Investigator

DrDoppalapudi Radhika

Saveetha Dental College, SIMATS

Study Sites (1)

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