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

NCT ID: NCT01215448

Last Updated: 2014-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-08-31

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.

Conditions

Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Lifestyle changes

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Wheatgrass juice & lifestyle changes

Wheatgrass juice \& lifestyle changes

Group Type: EXPERIMENTAL

Wheatgrass juice

Intervention Type: DIETARY_SUPPLEMENT

110 CC daily od frozen wheatgrass juice in the intervention arm

Interventions

Wheatgrass juice

110 CC daily od frozen wheatgrass juice in the intervention arm

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Triticum aestivum

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eran Ben-Arye

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eran Ben-Arye, MD

Role: PRINCIPAL_INVESTIGATOR

Clalait Health Services

Locations

Lin Medical Center

Haifa, , Israel

Countries

Israel

References

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. doi: 10.1080/01635580701308083.

Reference Type: BACKGROUND

PMID: 17571966 (View on PubMed)

Other Identifiers

CMC-10-0054-CTIL

Identifier Type: -

Identifier Source: org_study_id