The Effect of Ganoderma on Patients With Head-and-neck Cancer

NCT ID: NCT02238587

Last Updated: 2014-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-05-31

Brief Summary

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To study the effect of Ganoderma Spores Powder Capsules on the life quality and immunity status of the patients with head-and-neck cancer after complete treatment (including surgery and / or radiotherapy and/or chemotherapy)

Detailed Description

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Ganoderma is known to modulate immunity and improve health. However, the mechanism is not clear. We hypothesize that patients who have completed standard treatment with/without radiotherapy might require biological modifier such as Ganoderma to improve life quality and immunity status.

A total of 100 patients are randomized to study and control groups. In study group, Ganoderma Spores Powder Capsules are given to the patients for 6 weeks, In control group, only placebos are given during the same period. Then the patients in study and control groups are switched, Ganoderma Spores Powder Capsules and placebos are given for 6 weeks. The data pertaining to their Life quality are collected using Quality of Life Questionnaire after the first 6 weeks and the second 6 weeks. The immunity status is also studied at the same time.

Conditions

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Head-and-neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo/Ganoderma

In control group, oral placebos for 6 weeks. Then the patients in control groups are switched, Ganoderma Spores Powder Capsules are given for 6 weeks. The data pertaining to their life quality are collected using Quality of Life Questionnaire after the first 6 weeks and the second 6 weeks. The immunity status is also studied at the same time.

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type OTHER

In control group, only placebos are given for 6 weeks. The patients who are in control groups are switched to receive Ganoderma Spores Powder Capsules for 6 weeks.

Ganoderma Spores Powder Capsules

Intervention Type DIETARY_SUPPLEMENT

In experimental group, Ganoderma Spores Powder Capsules for 12 weeks.

Ganoderma

In experimental group, Ganoderma Spores Powder Capsules for 12 weeks. The data pertaining to their life quality are collected using Quality of Life Questionnaire after the first 6 weeks and the second 6 weeks. The immunity status is also studied at the same time.

Group Type EXPERIMENTAL

Ganoderma Spores Powder Capsules

Intervention Type DIETARY_SUPPLEMENT

In experimental group, Ganoderma Spores Powder Capsules for 12 weeks.

Interventions

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Control group

In control group, only placebos are given for 6 weeks. The patients who are in control groups are switched to receive Ganoderma Spores Powder Capsules for 6 weeks.

Intervention Type OTHER

Ganoderma Spores Powder Capsules

In experimental group, Ganoderma Spores Powder Capsules for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients with head-and-neck cancer after complete treatment for at least 3 months (including surgery and/or radiotherapy and/or chemotherapy)

Exclusion Criteria

* Patients with head-and-neck cancer under treatment or within 3 months after treatment
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Bing Show Chwan Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kuender D. Yang

MD, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kuender D. Yang, PhD

Role: STUDY_DIRECTOR

Chang Bing Show Chwan Memorial Hospital

Ching-Yeh Hsiung

Role: PRINCIPAL_INVESTIGATOR

Chang Bing Show Chwan Memorial Hospital

Locations

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Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital

Changhua County, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ching-Yeh Hsiung

Role: CONTACT

886-975617327

Kuender D. Yang

Role: CONTACT

886-975617006

Facility Contacts

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Kuender D. Yang, PhD

Role: primary

886-975617006

Other Identifiers

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1020304

Identifier Type: -

Identifier Source: org_study_id

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