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Clinical Trials/NCT01215448
NCT01215448CompletedNot Applicable

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

Carmel Medical Center1 site in 1 country17 target enrollmentStarted: October 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
17
Locations
1
Primary Endpoint
Assessing impact of wheatgrass juice and lifestyle recommendations on cancer patients' quality of life

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 95 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Lifestyle changes

No Intervention

Lifestyle changes(booklet and audio cassette of recommended diet, physical activity and breathing exercises)

Wheatgrass juice & lifestyle changes

Experimental

Wheatgrass juice & lifestyle changes

Intervention: Wheatgrass juice (Dietary Supplement)

Outcomes

Primary Outcomes

Assessing impact of wheatgrass juice and lifestyle recommendations on cancer patients' quality of life

Time Frame: 4 months

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

Secondary Outcomes

  • Assessing compliance of patients to lifestyle recommendations during chemotherapy(4 months)

Investigators

Sponsor
Carmel Medical Center
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eran Ben-Arye

integrative Oncology Program, Medical director, The Oncology Service and Lin Medical center, Clalit Health Services.

Carmel Medical Center

Study Sites (1)

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