Effect of exercise training in head and neck cancer patients
Phase 1
- Conditions
- Health Condition 1: C140- Malignant neoplasm of pharynx, unspecified
- Registration Number
- CTRI/2023/11/059839
- Lead Sponsor
- Father Muller Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with head and neck cancer (stage III & IV a & IV b) receiving CRT with Eastern Cooperative Oncology Group (ECOG) score <2.
Exclusion Criteria
1 Patients contraindicated to combined aerobic and resistance training
2 Platelet count : < 30000/µl.
3 Hb count : < 8gm/dl.
4 Patients with severe orthopaedic and neurological problems.
5 Inability to comply with study procedures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Sarcopenia will be evaluated by: <br/ ><br>a)Skeletal Muscle Mass, assessed using Bio Impedance Analyser (BIA) <br/ ><br>b)Muscle strength (as hand grip strength) using JAMAR hand Dynamometer <br/ ><br>c)Physical performance by Time-up-and- go test (TUG) <br/ ><br>2)Sleep quality will be assessed by: <br/ ><br>a)Urinary melatonin excretion by ELISA method <br/ ><br>b)Pitts Berg Sleep Quality Index <br/ ><br>3)Systemic inflammation assessed using inflammatory markers: <br/ ><br>a)Serum C-Reactive Protein (CRP), immunoturbidometric method <br/ ><br>b)Serum Albumin, Bromo cresol green dye binding method <br/ ><br>c)CRP/albumin ratio(CAR), calculated <br/ ><br>d)Neutrophil-Lymphocyte ratio (NLR), based on determination of these tests using automated cell counter <br/ ><br>e)Platelet-Lymphocyte ratio (PLR), based on determination of these tests using automated cell counter <br/ ><br> <br/ ><br>Timepoint: Pre chemo-radiation day 1 and at the end of 7th week
- Secondary Outcome Measures
Name Time Method 4)Quality of life, assessed by the FACT-H&N scale. <br/ ><br>5)Fatigue is assessed by Brief Fatigue Inventory Scale <br/ ><br>6)Functional Capacity: using a six -minute walk test. <br/ ><br>Timepoint: Pre Chemo-radiation day 1 and at the end of 7th week