MedPath

Yoga and Head & Neck Cancer

Phase 3
Conditions
Health Condition 1: C760- Malignant neoplasm of head, face and neck
Registration Number
CTRI/2024/01/061128
Lead Sponsor
Division of Yoga, Centre for Integrative Medicine and Research [CIMR-Yoga]
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Histologically or cytologically confirmed cases

2. Stage - T1 to T4b, NX to N3b and M0 - as per AJCC Staging

3. Functional ability as per Eastern Cooperative Oncology Group Score 0–1

4. Willing to undertake home-based yoga practice

Exclusion Criteria

1. Metastatic HNSCC,

2. Other comorbid conditions, including psychiatry

3. Patients with intravenous antibiotics

4. Exposure to Yoga in the past three months

5. Patients with continued substance abuse

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
EORTC-QLQ-C30 <br/ ><br>EORTC-QOQ H&N35Timepoint: Day0 <br/ ><br>Week6 or 7 <br/ ><br>Week10 0r 11 <br/ ><br>Week24 <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
1. Superoxide dismutase (SOD) <br/ ><br>2. Malondialdehyde (MDA) <br/ ><br>3. Systemic immune inflammation index (SIII) <br/ ><br>4. Systemic Inflammation Response Index (SIRI) <br/ ><br>5. Modified Glasgow prognostic score (mGPS) <br/ ><br>6. Montreal Cognitive Assessment (MoCA) <br/ ><br>7. The Distress thermometer (DT) <br/ ><br>8. Depression, Anxiety, & Stress Scale questionnaire (DASS- 21) <br/ ><br>9. Pittsburgh Sleep Quality Index <br/ ><br>10. EORTC FA-12 (Cancer-Related Fatigue Module) <br/ ><br>Timepoint: Day0 <br/ ><br>Week6 or 7 <br/ ><br>Week10 0r 11 <br/ ><br>Week24
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