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Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients

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赞助商
University of Westminster
合作者
All India Institute of Medical Sciences, New Delhi

关键词

抽象

The main aim of the study is to assess the effectiveness of tailored nutritional intervention in delaying the progression of cachexia to refractory cachexia in adult female cancer patients.
The tested hypothesis stated that intake of nutrient rich bread mix (along with dietary and physical activity counselling) for six months, improved the anthropometric and biochemical indices in free-living patients suffering from cancer cachexia.

描述

Patients were randomly distributed into two groups i.e. control and intervention group. 30 patients were allocated in intervention group and received nutrient rich bread mix i.e. IAtta (100 g) along with dietary and physical activity counseling and 33 patients were allocated in the control group who received only dietary and physical activity counseling. Patients in the intervention group collected 14 packets of 100 g of IAtta every fortnight during their clinician appointments while the control patients were advised regarding their dietary habits at every clinician visit for 6 months.

Dietary counseling for 30 minutes was imparted to all patients on each visit by the researcher. Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), was encouraged daily during counseling sessions.

Nutritional, biochemical, quality of life and anthropometric estimations were assessed at baseline, after 3 months and at 6 months of intervention for all patients.

Patients' daily energy, carbohydrate, protein and fat intake were calculated using food frequency (Indian Migrant study food frequency questionnaire- IMS-FFQ) questionnaire and two day 24 hour recall data. PG-SGA questionnaire was used to monitor patient nutritional status throughout the study.

EORTC-QLQ- C30 questionnaire was used to analyse patients' quality of life and asked personally by the researcher.

Haemoglobin and serum albumin levels were assessed at the start of the study, after 3 months and at 6 months of intervention for all patients.

Indian Migrant Study Physical Activity questionnaire (IMS-PAQ) was used to assess patients' physical activity throughout the day.

Anthropometric estimations included body weight, mid upper arm circumference and four site skin fold thickness (SFT) measurement (i.e. triceps, biceps, subscapular and suprailiac).

日期

最后验证: 12/31/2014
首次提交: 01/25/2015
提交的预估入学人数: 01/28/2015
首次发布: 01/29/2015
上次提交的更新: 01/28/2015
最近更新发布: 01/29/2015
实际学习开始日期: 11/30/2013
预计主要完成日期: 06/30/2014
预计完成日期: 07/31/2014

状况或疾病

Cachexia
Cancer

干预/治疗

Dietary Supplement: Intervention group

Other: Nutritional counseling

Behavioral: Physical activity counseling

相 2

手臂组

干预/治疗
Experimental: Intervention group
Patients in the intervention group were given dietary supplement (Improved Atta: 100 g) daily along with nutritional counseling and physical activity counseling for six months.
Dietary Supplement: Intervention group
Improved Atta is a multi macro- micronutrient bread mix. Patients were given 100 grams of Improved Atta (in the from of unleavened bread) everyday for consumption for six months.
Other: Control group
Patients in the control group were given nutritional and physical activity counseling for six months every fortnight.

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别Female
接受健康志愿者
标准

Inclusion Criteria:

- Female, age 18 years and above.

- Diagnosed with cancer.

- Weight loss >5% from pre-treatment weight or BMI<20kg/m2.

- Hemoglobin level <12 g/dl.

- Energy intake < 1500 kcal/d (to be assessed on consultation).

Exclusion Criteria:

- Incapable to provide written consent.

- Patient diagnosed with refractory cachexia.

- Life expectancy < 3 months.

- Unresponsive to anti-cancer therapy.

- Patient is a pregnant woman or a nursing mother.

- Suffering from secondary illnesses.

- Gastrointestinal tract defects which affect nutrient absorption

结果

主要结果指标

1. Body weight [6 months]

Body weight was assessed using a Tanita segmental composition scale at baseline, mid-intervention (3 months) and at the end of intervention (6 months).

次要成果指标

1. Mid upper arm circumference (MUAC) [6 months]

MUAC was measured using a non-stretchable measuring tape at baseline, mid-intervention (3 months) and at the end of intervention (6 months).

2. Body fat percentage (BF%) [6 months]

Four site skin fold thickness (SFT) measurement (i.e. triceps, biceps, subscapular and suprailiac) by the help of scientific Harpenden Skinfold Caliper was noted to the nearest 0.2mm reading, to calculate percentage body density. Body fat percentage was calculated using body density value in Siri equation. SFT was measured at baseline, mid-intervention (3 months) and end of intervention (6 months) to determine the BF%.

3. Nutritional status assessment (Indian Migrant study food frequency questionnaire (IMS-FFQ), two day 24 hour dietary recall and patient generated subjective global assessment) [6 months]

Indian Migrant study food frequency questionnaire (IMS-FFQ), two day 24 hour dietary recall and patient generated subjective global assessment were used to assess patient nutritional status at baseline, mid-intervention and end of intervention (6 months). Food frequency questionnaire and 24 hour dietary recall is an accurate method to record the frequency of consumption of individual foods and can help provide information on patients' eating patterns.IMS-FFQ consists of 184 commonly consumed food items and was validated among the rural and urban Indian population. PG-SGA is most effective and sensitive tool for assessing and evaluating cancer patients' nutritional status and validated on Indian cancer patients.

4. Physical activity assessment (Indian Migrant Study Physical Activity questionnaire (IMS-PAQ) [6 months]

Indian Migrant Study Physical Activity questionnaire (IMS-PAQ) was used to assess patients' physical activity throughout the day. We assessed physical activity at three time points during the study: baseline, at 3 months of intervention and at 6 months end of intervention. IMS-PAQ is a validated questionnaire on both Indian rural and urban population.

5. Quality of life (QoL) assessment (EORTC-QLQ- C30 questionnaire) [6 months]

EORTC-QLQ- C30 questionnaire was used to analyse patients' QoL at baseline, mid- intervention and at the end of intervention period.

6. Haemoglobin (Haemoglobin levels) [6 months]

Haemoglobin levels were monitored at baseline, at three months and at the end of intervention (6 months).

7. Serum albumin (Serum albumin levels) [6 months]

Serum albumin levels were monitored at baseline, at three months and at the end of intervention (6 months).

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