NCT04082793

Brief Summary

Head and neck cancer originate from the several different anatomical subsites especially the squamous cell carcinoma. This involves mainly Oropharynx, Hypopharynx, and Larynx. The common treatment approaches for HNC is radiation therapy, alone or combined with chemotherapy and surgery. In the present scenario, very little literature is available improving the QOL by physiotherapeutic measures in patients with HNC. To improve QOL, a well-designed study is needed. The study will be a two-group pretest-posttest design. The study will include patients with HNC receiving radiation or chemotherapy. One group will receive photobiomodulation therapy and another group will receive Sonophoresis. Both the group will receive Mandibular mobilization and stabilization exercises after electrotherapy. The Algometer, Digital Vernier caliper and core measure Questionnaire-C30 (QLQ-C30) will be used as an outcome measure to measure the effect of interventions between baseline and post-interventions.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable head-and-neck-cancer

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, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

August 31, 2019

Last Update Submit

March 6, 2020

Conditions

Head and Neck CancerTrismus

Keywords

ElectrotherapyPhotobiomodulationQuality of life

Outcome Measures

Primary Outcomes (2)

  • Algometer

    Algometer is a digital calibrated outcome measure, measures the pain pressure threshold.

    Change from baseline, 2 weeks after intervention and at the end of 4th week will be measured.

  • Core measure Questionnaire-C30 (QLQ-C30)

    The questionnaire are designed to measure physical, social and psychological functions of patients with cancer. The questionnaire contains physical, social, emotional and cognitive functioning multi item scales and 9 single items. These items are pain, fatigue, financial impact, appetite loss, nausea and vomiting, diarrhea, constipation, sleep disturbance and quality of life. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Time required for administration is 10 to 15 minutes.

    Change from baseline, 2 weeks after intervention and at the end of 4th week will be measured.

Secondary Outcomes (1)

  • Digital Vernier calliper

    Change from baseline, 2 weeks after intervention and at the end of 4th week will be measured.

Study Arms (2)

Photobiomodulation group

EXPERIMENTAL

Low-level laser therapy will be given to the PTMB group along with mandibular mobilization and stabilization exercises

Combination Product: Photobiomodulation therapy with mandibular exercisesCombination Product: Sonophoresis with mandibular exercises

Sonophoresis group

EXPERIMENTAL

Ultrasonic massage with diclofenac gel will be given to the sonophoresis group along with mandibular mobilization and stabilization exercises

Combination Product: Photobiomodulation therapy with mandibular exercisesCombination Product: Sonophoresis with mandibular exercises

Interventions

Photobiomodulation therapy with mandibular exercisesCOMBINATION_PRODUCT

Low-level laser therapy (BMI 1005 Laser 2200) Wavelength: 658 nm Power: 100 MW Energy density: 4J/cm2 Dose administered: 4J Mode: Pulsed Site of application: Over bilateral Temporomandibular joint Number of sessions: 3 sessions/week on alternating days for 12 minutes each, for 4 weeks Mandibular mobilization exercises Side to side movement of the jaw Forward jaw movement Tongue up Goldfish exercise (Partial opening) Goldfish exercise (Full opening) Exercise duration: 6 repetitions X 2 sets X 4 times a day Mandibular Stabilization exercises Exercise duration: 5 repetitions X 3 sec. Hold X 4 times a day

Also known as: Low-level laser therapy
Photobiomodulation groupSonophoresis group
Sonophoresis with mandibular exercisesCOMBINATION_PRODUCT

Ultrasound (BM1-1039) Ultrasonic massage with Diclofenac gel Frequency: 1.0 MHz Mode: Continuous Intensity: 0.8 to 1.5 W/cm2 Site of application: Over bilateral Temporomandibular joint Number of sessions: 3 sessions per week on alternating days for 8 minutes each, for 4 weeks Mandibular mobilization exercises Side to side movement Forward jaw movement Tongue up Goldfish exercise (Partial opening) Goldfish exercise (Full opening) Exercise duration: 6 repetition X 2 sets X 4 times a day Mandibular Stabilization exercises Exercise duration: 5 repetitions X 3 sec. Hold X 4 times a day

Also known as: Ultrasonic massage with diclofenac gel
Photobiomodulation groupSonophoresis group

Eligibility Criteria

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

You may qualify if:

  • Patients with Clinical diagnosis of HNC undergoing chemo and radiation therapy
  • Patient having joint pain and stiffness following chemo and radiation therapy
  • Patients with the age group of 18 - 70 years

You may not qualify if:

  • Patients with Mandibular reconstruction surgery
  • Patients with platelet count \<80,000/µl of blood and haemoglobin count \<8g/dl
  • Patients with cervical spine dysfunction and nerve damage
  • Patients who is not willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Gautam AP, Fernandes DJ, Vidyasagar MS, Maiya AG, Vadhiraja BM. Low level laser therapy for concurrent chemoradiotherapy induced oral mucositis in head and neck cancer patients - a triple blinded randomized controlled trial. Radiother Oncol. 2012 Sep;104(3):349-54. doi: 10.1016/j.radonc.2012.06.011. Epub 2012 Aug 10.

    PMID: 22884841BACKGROUND

  • Zecha JA, Raber-Durlacher JE, Nair RG, Epstein JB, Elad S, Hamblin MR, Barasch A, Migliorati CA, Milstein DM, Genot MT, Lansaat L, van der Brink R, Arnabat-Dominguez J, van der Molen L, Jacobi I, van Diessen J, de Lange J, Smeele LE, Schubert MM, Bensadoun RJ. Low-level laser therapy/photobiomodulation in the management of side effects of chemoradiation therapy in head and neck cancer: part 2: proposed applications and treatment protocols. Support Care Cancer. 2016 Jun;24(6):2793-805. doi: 10.1007/s00520-016-3153-y. Epub 2016 Mar 17.

    PMID: 26984249BACKGROUND

  • Shin SM, Choi JK. Effect of indomethacin phonophoresis on the relief of temporomandibular joint pain. Cranio. 1997 Oct;15(4):345-8. doi: 10.1080/08869634.1997.11746030.

    PMID: 9481998BACKGROUND

  • Samuel SR, Maiya GA, Babu AS, Vidyasagar MS. Effect of exercise training on functional capacity & quality of life in head & neck cancer patients receiving chemoradiotherapy. Indian J Med Res. 2013 Mar;137(3):515-20.

    PMID: 23640558BACKGROUND

  • Samuel SR, Maiya AG, Fernandes DJ, Guddattu V, Saxena PUP, Kurian JR, Lin PJ, Mustian KM. Effectiveness of exercise-based rehabilitation on functional capacity and quality of life in head and neck cancer patients receiving chemo-radiotherapy. Support Care Cancer. 2019 Oct;27(10):3913-3920. doi: 10.1007/s00520-019-04750-z. Epub 2019 Mar 27.

    PMID: 30919154BACKGROUND

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsTrismus

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Neha Sharma, MPT

    Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asir J Samuel, MPT, (PhD)

CONTACT

8059930222asirjohnsamuel@mmumullana.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Participants, outcome assessors and care provider will be blinded in the study. This will be a triple blinded randomized controlled trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 31, 2019

First Posted

September 9, 2019

Study Start

June 1, 2020

Primary Completion

March 31, 2021

Study Completion

May 31, 2021

Last Updated

March 9, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share