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

Fatigue Clinical Trial

— 4001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215448
• Other study ID #: CMC-10-0054-CTIL
• Status: Completed
• Phase: N/A
• First received: September 28, 2010
• Last updated: June 16, 2014
• Start date: October 2010
• Est. completion date: August 2013

Study information

• Verified date: June 2014
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fatigue

Intervention

Dietary Supplement:
• Wheatgrass juice
110 CC daily od frozen wheatgrass juice in the intervention arm

Locations

Country	Name	City	State
Israel	Lin Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Bar-Sela G, Tsalic M, Fried G, Goldberg H. Wheat grass juice may improve hematological toxicity related to chemotherapy in breast cancer patients: a pilot study. Nutr Cancer. 2007;58(1):43-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No