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Effectiveness of a Physical Recovery Program for Head and Neck Cancer Patients (3C-CUIDATE)

U

University of Granada (UGR)

Status

Completed

Conditions

Dysfunction
Head and Neck Cancer
Pain

Treatments

Other: Manual therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04145180
0045-N-16

Details and patient eligibility

About

People receiving a head and neck cancer treatment often do not find an adequate therapeutic response for the side effects derived from this treatment. The objective of this study is to assess the effectiveness of a physical recovery program based on manual therapy over these problems.

Previous studies have shown the effectiveness of this type of programs on patients who have had cancer in other locations with clinically relevant results. There is a shortage of proposals for this subgroup of patients that require special attention. This project intends to carry out an experimental randomized controlled study with 84 patients treated of head and neck cancer who will be assigned randomly to the study groups: a) manual therapy program or, b) control group. The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 months of patient follow-up.

Full description

Manual therapy program consists of 3 sessions a week during 6 weeks, with a total of 18 appointments. Measurements are done before starting, after the last intervention and 6 months after finishing the treatment.

Enrollment

55 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • To have ended their treatment in the previous 6-24 months
  • To have no metastasis or active cancer
  • To have cervical and/or temporomandibular joint pain >3 in a Visual Analogue Scale

Exclusion criteria

  • Mental or physical illness preventing subjects from participating in the study
  • Previous chronic pain conditions
  • Previous cervical or temporomandibular joint pain
  • Previous dysphagia disorders

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

55 participants in 2 patient groups

Manual Therapy
Experimental group
Description:
Manual Therapy-based intervention
Treatment:
Other: Manual therapy
Control
No Intervention group
Description:
Patients waiting list

Trial contacts and locations

1

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Central trial contact

Lucía Ortiz-Comino, MSc; Carolina Fernández-Lao, PhD

Data sourced from clinicaltrials.gov

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