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

Not Applicable

Completed

• Conditions: Fatigue

• Registration Number: NCT01215448
• Lead Sponsor: Carmel Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-09-28
• Study Start: 2010-10
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-06
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-16
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assessing impact of wheatgrass juice and lifestyle recommendations on cancer patients' quality of life	4 months	Assessing impact of wheatgrass juice and lifestyle recommendations on cancer patients' quality of life(including fatigue)during chemotherapy

Secondary Outcome Measures

Name	Time	Method
Assessing compliance of patients to lifestyle recommendations during chemotherapy	4 months	Assessing compliance of patients to lifestyle recommendations (diet, physical activity and breathing exercises) during chemotherapy

Trial Locations

Locations (1)

Lin Medical Center; 🇮🇱 Haifa, Israel