Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03114202
Other study ID # 1.954.066
Secondary ID
Status Recruiting
Phase N/A
First received March 23, 2017
Last updated July 14, 2017
Start date April 18, 2017
Est. completion date October 1, 2018

Study information

Verified date March 2017
Source University of Sao Paulo General Hospital
Contact Jose Eluf Neto
Phone +55(11)3061-8278
Email jose.eluf@hc.fm.usp.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigates the effects of nutritional counseling versus standard nutritional care on nutritional status and quality of life in patients with head and neck cancer submitted to radiotherapy.Half participants will receive intensive nutritional counseling while the other half will receive standard care.


Description:

Considering that head and neck cancer patients usually present reduced food intake with consequent involuntary weight loss and significant worsening of quality of life, this study investigates the effects of nutritional counseling versus standard nutritional care on nutritional status and quality of life in patients with head and neck cancer submitted to radiotherapy.

Half participants (45) will receive intensive nutritional counseling, that is, once they are admitted to the study and once a week during radiotherapy, following the protocol of nutritional care to cancer patients in radiotherapy proposed by the American Dietetic Association (ADA).

The other half (45) will receive standard care, that is, nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist (when there is a demand, usually 1 to 2 times during oncologic treatment).


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date October 1, 2018
Est. primary completion date August 6, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with head and neck cancer (oral cavity, oropharynx, hypopharynx and larynx); both sexes; aged 18 years and over, submitted to radiotherapy after chemotherapy or radiotherapy as a first-choice treatment or as adjuvant treatment (post-surgical).

Exclusion Criteria:

- Patients using parenteral nutrition; without cognitive ability to understand the concepts of the questionnaires; in palliative radiotherapy.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
intensive nutritional counseling
Individualised nutrition intervention in the form of regular and intensive nutrition counselling by a dietitian, following a predetermined standard nutrition protocol, the Medical Nutrition Therapy (Cancer/Radiation Oncology) protocol of the American Dietetic Association (ADA) every week during radiotherapy. Individually tailored sample meal plans, recipe suggestions and hints to minimise the side effects of the tumour and therapy will be provided.
Standard care
Nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist.

Locations

Country Name City State
Brazil Centro de Oncologia da Santa Casa Nossa Senhora do Perpétuo Socorro Alfenas Minas Gerais
Brazil Fundação Hospitalar do Município de Varginha - Hospital Bom Pastor Varginha Minas Gerais

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in weight Defined as mean weight change Baseline and 12 weeks
Primary Change in nutritional status Defined as mean body mass index change Baseline and 12 weeks
Primary Change in quality of life Self reported quality of life assessed using two questionnaires - Functional Assessment of Cancer Therapy - Head and Neck (FACT-H & N) and European Organization for Research and Treatment of Cancer - Quality of life questionnaire - Head and Neck (EORTC-QLQ-H & N35). Baseline and 12 weeks
Secondary Change in patient generated subjective global assessment Self reported nutritional assessment by the Scored Patient-Generated Subjective Global Assessment (PG-SGA) Baseline and 12 weeks
Secondary Energy and protein intake Mean changes in energy and protein intake, assessed by the 24 hour recording Baseline and 12 weeks
Secondary Fat free mass Mean changes in fat free mass, assessed by foot-to-foot bioimpedance Baseline and 12 weeks
Secondary Occurrence of complications due to radiotherapy Number of patients with complications due to radiotherapy, assessed from medical record 12 weeks
Secondary Occurrence of unplanned hospitalization Number of patients with unplanned hospitalization, assessed from medical record 12 weeks
Secondary Occurrence of interruption or delay in treatment. Number of patients with interruption or delay in treatment, assessed from medical records 12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05980598 - TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT02548377 - Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial N/A
Active, not recruiting NCT02229656 - Olaparib and Radiotherapy in Head and Neck Cancer Phase 1
Not yet recruiting NCT06347185 - Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study N/A
Not yet recruiting NCT06289049 - Heavy Strength Training in Head and Neck Cancer Survivors Phase 2
Terminated NCT02975739 - Feasibility of Holmium-166 Micro Brachytherapy in Head and Neck Tumors N/A
Recruiting NCT00982436 - Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer Phase 1/Phase 2
Completed NCT01025518 - DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients N/A
Active, not recruiting NCT00248235 - Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer Phase 2/Phase 3
Terminated NCT00073450 - Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530) Phase 2
Completed NCT00135161 - Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer Phase 1
Not yet recruiting NCT06458517 - Evaluation of Two Methods of Administration of Photobiomodulation in the Context of the Prevention and Treatment of Mucositis Induced by Radiotherapy, During the Treatment of Head and Neck Cancers N/A
Completed NCT05269342 - Nurse-led Exercise Improves Shoulder Pain, Shoulder Disability, and Quality of Life in Head and Neck Cancer N/A
Recruiting NCT05544136 - A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer Phase 2
Terminated NCT03286972 - PET/MRI to Enhance Precision Guidance in Head and Neck Radiation Treatment Planning
Recruiting NCT04435938 - A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck Phase 2
Recruiting NCT03678649 - A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC Phase 2
Recruiting NCT03975465 - EMST and Swallowing in Long-Term Survivors of HNCA N/A
Completed NCT03292250 - Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)] Phase 2
Completed NCT06446570 - Phase II Study of Durvalumab(MEDI4736) + Tremelimumab in Pulmonary Sarcomatoid Carcinoma Phase 2