Wheatgrass Juice / Lifestyle Recommendations / Cancer Patients' Quality of Life / Chemotherapy Treatment

Study Overview
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Brief Summary
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This study is aimed to study the impact of wheatgrass juice and lifestyle recommendations (diet, physical activity and breathing exercises) on the well being, fatigue and hematological parameters of chemotherapy-naive patients with no evidence for symptoms of active oncological disease.The researchers hypothesize that both wheatgrass juice and lifestyle recommendations can improve patient's well-being during chemotherapy.

Detailed Description
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Chemotherapy-naive patients will be offered to participate in a two arms study. Following consent, patients will be randomized to one of two arms. Patients in both arms will be provided by booklet and audio-cassette that specify lifestyle recommendations (diet, physical activity and breathing exercises). Patients in one of the study arms will be provided in addition with frozen wheatgrass juice (recommended daily dosage of 55-110 CC daily). Patients in both arms will be asked to fill in a daily patient's diary monitoring the practice of the lifestyle recommendations. Baseline assessment will include the following questionnaires: ESAS, MYCAW, FACIT- Fatigue. Evaluation will include weekly ESAS and FACIT-Fatigue questionnaire and subsequent evaluation (including ESAS, MYCAW, FACIT- Fatigue questionnaires) following 3 and 4 chemotherapy cycles of treatment. Follow-up evaluation will be performed at the completion of chemotherapy.

Official Title
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Impact of Wheatgrass Juice and Lifestyle Recommendations on Cancer Patients' Quality of Life During Chemotherapy Treatment

Conditions
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Fatigue

Intervention / Treatment
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* Dietary Supplement: Wheatgrass juice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of cancer with no sign of active disease First-time treatment with chemotherapy Exclusion Criteria: Treatment with per os administration of chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Lifestyle changes<br>Lifestyle changes(booklet and audio cassette of recommended diet, physical activity and breathing exercises) | |
| Experimental: Wheatgrass juice & lifestyle changes<br>Wheatgrass juice & lifestyle changes | Dietary Supplement: Wheatgrass juice<br>* 110 CC daily od frozen wheatgrass juice in the intervention arm<br>* Other names: Triticum aestivum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing impact of wheatgrass juice and lifestyle recommendations on cancer patients' quality of life | Assessing impact of wheatgrass juice and lifestyle recommendations on cancer patients' quality of life(including fatigue)during chemotherapy | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing compliance of patients to lifestyle recommendations during chemotherapy | Assessing compliance of patients to lifestyle recommendations (diet, physical activity and breathing exercises) during chemotherapy | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Quality of life, Lifestyle, Complementary medicine